Introduction
Falling is a major cause of morbidity and mortality in our society [1]. Falls often occur during gait [2], possibly caused by poor balance [3]. A decline in balance during gait, with increased gait variability and an associated increased risk of falls, correlates with aging [4] and with the presence of vestibular, cerebellar, functional, or other neurological diseases [5]. When standing, balance can, for example, be defined as an individual’s ability to maintain their center of mass (CoM) within a base of support (BoS) [3, 5–7] or as “the continuous and adequate adaptation of body posture to avoid falling” [8]. When walking, it is suggested that the vertical projection of the CoM plus its velocity times a factor should be within the BoS [7]. When describing balance during walking, i.e. gait, ‘gait stability’ is an important indicator [5].
Gait stability is a broad concept that can generally be defined as the ability to keep walking regardless of disturbances or the presence of control errors [9, 10]. A multitude of definitions for the stability of bipedal gait exist. Some frequently used ones are summarized in Bioinspired Legged Locomotion, Chapter 4.1 [11]. Kuo and Donelan (2010) distinguish local stability, i.e. step-to-step stability concerned with small deviations from nominal gait, and global stability, i.e. a person’s susceptibility to falling [12]. Although the global definition has more clinical relevance, it is proposed that local stability is a useful indicator of walking balance [3, 5, 12].
Gait stability can be assessed with a wide variety of measures, each with its own level and type of validity [3, 13, 14]. For example, kinematic variability measures show convergent validity in experimental studies, which reflects an experimentally induced change in stability [3]. For the more clinical spatio-temporal measures, convergent validity is often not reported, but predictive validity in observational studies does exist [13], which describes the correlation between the measure and probability of falling. Lab-based stability measures, such as Lyapunov exponents, usually require kinematic and/or kinetic data obtained during walking, with post-processing, for their calculation [13, 15]. Clinical measures are often based on discrete score assignments or simple units of measure [13]. Consequently, they provide an indirect evaluation of balance and gait stability. For the purpose of keeping this review and search more inclusive, both lab-based and clinical measures of gait stability are considered.
Modulating gait stability can either be done directly, by (mechanical) manipulation [16], or indirectly, through training [17]. Mechanical manipulation is here defined as the transmission of forces, or moments, onto a body part, intending to influence human body kinematics. These include external forces and moments applied with respect to an external reference frame (e.g., the floor or wall) or internal forces and moments applied to parts of the body by means of a (wearable) power source (e.g., an actuator).
The complexity of gait stability manipulation and assessment and the desire to improve rehabilitation has encouraged the development of robotic tools [8] that can either improve or disrupt balance to train balance [18, 19]. However, which body part must be manipulated for maximum effect remains a challenge and depends on the user’s limitations. While understanding of mechanisms underlying gait stability is improving [13, 20, 21], limited evidence exists on how various assistive devices perform in terms of gait stability.
When looking at balance, it has been reported that even small, haptic, or vibrotactile, forces can improve balance performance when the point of application is chosen correctly, such as on the hand [22] or on the hip [23]. It has also been shown that the point of application of a force on the upper body greatly influences gait velocity [24]. Similarly, the sensitivity of human gait stability to external forces or moments might vary between their points of application on the body. When developing novel devices, such as cold-gas thrusters, which can generate a linear force impulse [25], choosing the optimal point of application and impulse direction might be pivotal.
Various reviews exist on the definitions of gait stability [3, 13, 14] and on how devices are used to assess balance [8, 26]. To our knowledge, no overview exists on how actuated devices influence human gait stability and where and how they apply forces and moments on the body.
The primary aim of the study is to answer the following question: What is the level of evidence for different types of mechanical manipulations on improving gait stability? For this, we divided device type based on the point of application of forces and moments and their directions. The secondary aim is to create an overview of devices that directly impact gait stability and their manipulation characteristics, such as point of application of forces, force direction, control strategy, and peak force magnitude.
Furthermore, we categorise the reported outcome measures and their types of validity. Due to the heterogeneity of the reported outcome measures, this review will employ a best-evidence synthesis (BES) in order to objectify findings and compare amongst studies [27].
Methods
Study protocol and search strategy
The study protocol of this systematic review is registered on PROSPERO (CRD42020180631). The search strategy was developed according to the method described by Bramer et al. (2017) [28] and executed in collaboration with an information specialist from the Erasmus MC Medical Library, Rotterdam. In total, five databases were searched: Embase (Embase.com), Medline All (Ovid), Web of Science Core Collection (Web of Knowledge), Cochrane Central Register of Controlled Trials (Wiley), and Google Scholar. The databases were searched from inception to the 1st of December, 2022. The PRISMA guidelines were used for screening and reporting [29].
In summary, the search strategy was constructed by joining the following—synonyms and antonyms of—three concepts by AND; 1) gait/balance stability/symmetry; 2) (bio-)mechanical/kinematic manipulation; 3) devices/aids/robots. In Embase and Medline the index terms ‘gait’ and ‘walking’ were used to better define the scope. For redundancy, specific outcome measures keywords, such as ‘Lyapunov’, were joined to concept 3) with OR. The full search strategy for all databases can be found in the S1 Appendix.
Two authors (B.S. and S.J.) independently screened titles and abstracts of all identified studies and subsequently reviewed a selection of full texts based on the in- and exclusion criteria described in the next section. Any disagreements were arbitrated by P.B. and M.H.
Inclusion and exclusion criteria
To be included, studies had to: 1- contain any form of (mechanical) manipulation of gait stability in non-impaired subjects or in individuals with a locomotor problem due to a neurological or orthopedic condition, 2- have a pre-post intervention study design, 3- be written in English, and 4- be performed on humans. All peer-reviewed published studies were included, with no limit on the year of publication.
Studies were excluded if they: 1- contained a training phase between baseline and outcome measurements, 2- were performed in water, 3- investigated prosthetic devices, passive orthoses (kinetic tapes, elastic bands, rigid links locking joints, insoles), surgical procedures, functional electrical stimulation, visual feedback, vestibular sensory manipulation, vibrational feedback, exoskeletons with a fully-enforced multi-limb kinematic trajectory, 4- were performed in children aged less than 16, or 5- contained five or less participants (pilots and case reports), and 6- studies with perturbations were excluded unless the perturbation was applied to increase the challenge for the subject, while the main aim of the study was investigating a stabilising force or intervention. As literature that primarily addresses our research question is sparse, papers that look at gait stability in passing were included, as long as they enabled drawing conclusions on our research question.
In our initial PROSPERO registration, dead mass and elastic bands were also included. These were later dropped to focus the study on devices that provide external forces and moments or internal forces generated by a wearable actuator.
Data collection
For the included studies, data was collected by one of the researchers and reviewed by the other researcher. The following information was collected: 1- intervention and device type, 2- point of application of forces on the body, 3- force characteristics (i.e. main force direction, control strategy, and peak force magnitude), 4- population description (i.e. sample size, impairment, age mean and standard deviation), 5- intervention protocol, 6- reported outcome measures, and 7- main findings of the study).
Data analysis
Articles were grouped based on the point of application of forces and moments, and their directions. The evidence for impaired and non-impaired subjects was analysed separately. Instead of the meta-analysis mentioned in the preregistered protocol, a best-evidence synthesis (BES) was performed to allow comparison across heterogeneity outcome measures. The BES was based on; 1- the type of validity of the reported outcome measures and 2- the study’s quality and risk of bias score. Details of both criteria are described below. If a paper described multiple patient populations or multiple interventions, these were considered as separate studies if data presentation allowed separate interpretation. If not, the study was excluded. If a paper described multiple settings of one intervention type only the setting that showed the largest impact on gait stability was used.
Outcome measure validity.
Multiple reviews describe the various types of validity outcome measures [3, 13, 14, 30]. For the current review we used the categorisation and annotated type of validity as mentioned by Bruijn et al. (2013) [3], updated with recent literature [4, 15, 20, 31–40]. The system distinguishes four types of validity; 1) Construct validity—Whether the existence of a relationship between a measure and the probability of falling is plausible [3]. 2) Predictive validity in models—Whether the measure predicts a probability of falling in a simple model of human gait [41]. 3) Convergent validity in experimental studies—Whether the measure reflects an experimentally induced change in stability [42]. 4) Predictive validity in observational studies—Whether there is a correlation between the measure and the incidence—or probability—of falling in observational studies [43].
The categorisation and evidence for the various validity types can be found in Table 1. For the purpose of this study, we selected outcome measures for our analysis if at least predictive validity in observational studies was found. In the preregistration, we mentioned a broad range of outcome measures, e.g. maximum Lyapunov exponent, maximum Floquet multiplier, variability measures, long-range correlations, etc.. Upon occurrence in the included articles more measures were added to the inventory in Table 1. Outcome measures that were not mentioned in the included articles are not described in this overview.
[Figure omitted. See PDF.]
The references are provided for construct validity, predictive validity in models, convergent validity, and predictive validity in observational studies. F denotes evidence for falsification of support for a certain type of validity,—denotes no support or falsification of support for a certain type of validity was found.
Quality and risk of bias score.
In order to assess each study’s quality and risk of bias, we adopted the “Quality Assessment Tool for Before-After (Pre-Post) Studies With No Control Group” published by the National Institutes of Health (NIH) [53]. Two authors (B.S. and S.J.) scored each article independently, and after discussion, a final study score was awarded. Any conflicts were resolved by P.B. and M.H.. Some questions were deemed more important to the goal of our study, therefore their score weights were increased, specifically questions: 3 (intended user group), 5 (sample size), 10 (statistical analysis), and 11 (multiple base-line measurements). Questions 4 (participant enrollment) and 8 (blinding) were deemed Non-Applicable (NA) as these questions are irrelevant for our comparison. Our final questionnaire is provided in the S1 Table. Quality scores of 11 or higher were classified as ‘excellent’ quality, 8 to 10 were classified as ‘sufficient,’ and 7 or lower were ‘poor’ quality.
Best-evidence synthesis.
Based on a BES, the studies are categorised into five levels of evidence, ranging from Strong to Insufficient. The categorisation is based on the quality score and outcome measures’ type of validity. The full description is provided in Table 2. As the current study focuses on the direct effect of manipulations on gait stability during experiments, convergent validity was deemed most relevant. For the purpose of counting conflicting evidence, studies reporting a positive impact on gait stability were awarded a +1, studies reporting a negative impact received a -1, and those without conclusive findings received a zero. The net sum of these points determined the level of evidence in Table 2. For example, when four studies report an improvement in gait stability (+4) through measures with convergent validity, and one study reported a reduction in gait stability (-1) with similar outcome measure validity, the overall BES conclusion for the device based on these studies (+3) would be deemed ‘Strong’.
[Figure omitted. See PDF.]
The outcome of the BES can range from strong to insufficient evidence.
Results
Search results and identification of studies
All searches combined resulted in 4701 articles for screening. Title and abstract screening of all articles resulted in 171 articles for full-text screening. Assessment for eligibility led to the inclusion of 53 papers for analysis, see Fig 1 for more details.
[Figure omitted. See PDF.]
Preregistration of protocols and outcome measures was present in three studies [54–56]. Original data was made publicly available in seven studies [16, 54, 56–60], whereas seven studies mentioned data to be readily available upon request [61–67].
Categorisation
Overall 17 papers focused solely on impaired subjects, 28 papers focused on non-impaired subjects, and seven papers looked at both. One study added an artificial impairment to non-impaired participants by limiting movement of the leg [68]. A total of 81 interventions, taken from 53 articles, were included in the BES. A full description of all studies and the device characteristics can be found in Table 3.
[Figure omitted. See PDF.]
VT = Vertical, AP = anterior-posterior, ML = medio-lateral, NR = not reported, ABI = acquired brain injury, SCI = spinal cord injury, BWS = body weight support, GRF = ground reaction forces, PD = Parkinson’s disease, HD = Huntington’s disease, NR = not reported, BW = body weight.
Studies were divided into four groups; Trunk (n = 8), Pelvis (n = 19), Upper Extremity (n = 11), and Lower Extremity (n = 16), where Goncalves et al. [69] is counted towards both the Trunk and the Pelvis group for their two device types.
For the BES we identified 27 different subgroups based on population and type of intervention. A full description of each subgroup can be found in Table 4. A visual representation of the evidence levels concluded during the BES can be found in Fig 2. The outcomes of the quality and risk of bias assessment can be found in the S2 Table.
[Figure omitted. See PDF.]
Best-evidence synthesis (BES) conclusions for a) impaired and b) non-impaired subjects. Arrows indicate the point of application and main direction(s) of the forces and moments. Colours and line type indicate the level of evidence. The letter and number combinations are indices for the device types. P = Pelvis, P1: Medio-lateral forces, P2: 3D forces, P3: Vertical body weight support (BWS) unloading, while pelvis’ sway, roll, and yaw motions locked, P4: Vertical BWS unloading force, with trunk motion, pelvis’ sway, roll, and yaw motions locked, P5: Medio-lateral pelvis manipulation combined with handrail. L = Lower extremity, L1: Knee joint torque applied over thigh and shank, L2: Hip joint torque applied to pelvis and thigh, L3: Medial damping force applied to the shank, L4: Lateral damping force applied to the shank, L5: Forward assistance force applied to the shank, L6: Ankle joint torque applied by a powered ankle foot orthosis. T = Trunk, T1: Vertical BWS to the trunk, T2: Vertical BWS plus medio-lateral damping, T3: Flywheel-based torques applied to the trunk. Manipulation of the frontal plane medio-lateral trunk angle, T4: BWS plus handrail. U = Upper extremity, U1: Walking poles, walking sticks, cane, and crutches, U2: Walkers, ranging from non-wheeled to four-wheeled, U3: Handrail, U4: Forward force provided to the hand by a leash.
[Figure omitted. See PDF.]
For each device and intervention type, the overall BES is presented and followed by a description of the findings of the articles that were considered within that group. The change of the outcome measure as a result of using the device is denoted as; ↓—decrease, ↑—increase, ~—negligible, *—significant, NR—not reported.
Outcome measures
Across the 53 articles, we found more than 100 unique outcome measures, which were categorised into eleven categories based on their functional definitions, see Table 1. Due to this large number of measures, we denoted the outcome measure in Table 4 as denoted by the authors without providing separate definitions.
The six most commonly reported outcome measures were step width (SW) (n = 22), step length (SL) (n = 14), step width variability step width variability (σSW) (n = 14), walking speed (n = 13), ML margin of stability (n = 11), and step length variability (σSL) (n = 7). Of these only σSW and σSL are reported to have convergent validity. Lyapunov exponent (λ) was reported in ten papers but was calculated over 15 unique parameters (e.g. knee angle, trunk velocity, CoM pos). Whole-body centroidal angular momentum (Hr) was reported only once (n = 1).
Due to the heterogeneity of the data and reported outcome measures, a meta-analysis was not possible.
Only within each large body-part category there was some consistency of reported outcome measures. Some examples: within the Pelvis group, σSW was measured 9 times, i.e. in 47% of the Pelvis studies. In all groups combined σSW was measured 14 times (26%). Similarly, WS was reported 9 times (82%) in the Upper Extremity group, compared to 13 times (25%) in all groups combined.
Best-evidence synthesis
Fig 2 shows the overview of the level of evidence that was found for each intervention type, by visualising the various interventions, as depicted by their main force directions and device schematics. The intervention type codes (T1, P3, U2, etc.) are related to the matching codes in Table 4.
Trunk.
From the included papers, eight involved trunk manipulation, describing five interventions. In non-impaired subjects, the most frequently used intervention was conventional body weight support (T1), which showed limited evidence for the improvement of gait stability [59, 61, 69–71]. Indicative evidence was provided in a single study applying both body weight support (BWS) and medio-lateral (ML) damping (T2) [61]. Two studies provided indicative evidence for improving gait stability by applying torques to the trunk (T3) [57, 72]. For impaired subjects, insufficient evidence was found on all intervention types.
Pelvis.
19 papers involved force application on pelvis manipulation, describing five device types. The most frequently investigated device type contains ML forces applied to the pelvis (P1), for which moderate and indicative evidence was found, respectively, for non-impaired [16, 56, 58, 60, 65, 73–80] and impaired [60, 62, 73, 75, 78, 80–82] subjects. Other studies described BWS forces to the pelvis (P2), pelvis restriction devices (P3 and P4), and the effect of handrail combined with pelvis stabilisation (P5), providing insufficient evidence.
Upper extremity.
Twelve papers involved force application on the upper extremity (hands/arms), describing four device types. Devices included the use of canes and walking sticks, walkers, handrails, and a leash. For walkers (U2), moderate and indicative evidence for reducing gait stability was found, respectively, for impaired subjects [83, 84] and non-impaired subjects [85, 86]. We found limited evidence for the improvement of gait stability with the use of walking-sticks and poles in impaired subjects (U1) [64, 84, 87–90]. In contrast, for non-impaired subjects indicative evidence for improving gait stability was found [64, 91, 92]. Other studies provided insufficient evidence.
Lower extremity.
From the included articles, 16 involved force and/or torque application on the lower extremity, describing 6 device types, including external forces applied to the shank and powered hip-, knee- and ankle orthoses. Indicative evidence on improving gait stability was found for applying a knee-joint torque (L1) to non-impaired subjects [93–95]. Hip flexion assistance (L2) produced indicative and limited evidence respectively for non-impaired [96] and impaired subjects [54, 63, 66, 68]. The use of a powered ankle foot orthosis (AFO) (L6) shows contradictory findings for both impaired [55, 97] and non-impaired subjects [67, 98]. Other intervention types provided insufficient evidence.
Discussion
Main findings
For the impaired subjects, the highest level of evidence was found for ML pelvis stabilisation, showing indicative levels of evidence for improving gait stability. Limited evidence was found for hip joint stabilisation and canes. Interestingly, walkers produced a moderate level of evidence for reducing gait stability in impaired subjects. In non-impaired subjects, a moderate level of evidence was found for ML pelvis stabilisation, and limited evidence was found for body weight supports. For all other device types, at most, indicative evidence was found. Noteworthy is the indicative level of evidence that was found for reducing gait stability for hip joint assistance and walkers in non-impaired subjects. Due to the heterogeneity of the reported outcome measures, especially between groups, no meta-analysis was possible.
Best-evidence synthesis
Finding a moderate level of evidence for (P1) ML pelvis manipulation of non-impaired subjects was not surprising, as this is generally assumed [16]. One reason might be that due to the proximity of the pelvis to the CoM, any forces applied to the pelvis almost directly influence CoM motion, the derivatives of which are major predictors of gait stability [3]. However, in impaired individuals, we unexpectedly found a lower level of evidence, mainly due to conflicting findings in the studies. Possibly disturbing a compensatory walking strategy in impaired subjects initially decreases gait stability, as adaptation periods are required before subjects utilise supporting forces and moments [106, 107]. All other articles related to pelvic manipulations were exploratory studies providing insufficient evidence. No studies were found that provided controlled AP or rotational support to the pelvis. This is possibly an interesting direction of study as manual rotational facilitation to the pelvis is used in the clinic to manipulate the gait of patients [108].
Concerning trunk manipulation, only the direct vertical body weight unloading method (T1) provided limited evidence for improving gait stability in non-impaired subjects. These findings are similar to findings reported by Apte et al. (2020) [109], although these effects might also be due to the medio-lateral centering effect of BWS systems [24]. BWS in combination with mediolateral damping to the pelvis (T2) provided indicative evidence. More indicative evidence was found for (T3) devices that apply moments to the trunk, such as backpacks containing gyroscopes or oscillating masses, though only few studies were found in this group. The strong link between the angular momentum of the body and gait stability makes this a promising direction of investigation [13].
A variety of interventions were used to manipulate the lower extremity. Due to differences between devices, each group contained few papers, generating limited evidence at best. Limited evidence was found for hip joint torque applied to the pelvis and thigh (L2) in impaired subjects. This is mainly caused by the limited use of outcome measures with convergent validity. Indicative evidence was found for devices that apply forces to the shank to manipulate the foot placement (L3). Foot placement is one of the critical elements of balance during walking [110]. The complexity of grabbing and manipulating the shank while in mid-air might explain the limited number of studies.
The studies that focused on the upper extremity generated contradictory results. For impaired subjects, the investigations on walking sticks provided only limited evidence for improving gait stability, mainly due to contradictory findings. A systematic review by Oates et al. (2017) described a reduction in variability of gait parameters and body stability as a result of haptic input of canes and handrails [111]. It is noteworthy that most of these papers did not measure or quantify the interaction forces between the subject and the device, making it difficult to replicate or compare their results. One clear finding is the evidence for the reduction of gait stability caused by walkers, in both the non-impaired and impaired groups. Walkers are known to alter posture and arm swing [84, 85, 112], thereby influencing overall gait stability.
Performing a study with non-impaired subjects is a logical first step in evaluating novel medical technology, as it is easier to obtain ethical approvals. This most likely explains their high occurrence in our review. Nevertheless, an investigation of improvements in gait stability in non-impaired people offers only very limited insights into the potential effects for rehabilitation. For example, our indicative finding that devices such as walking poles and sticks improve gait stability in non-impaired subjects does not provide a meaningful basis for any conclusions on the possible benefits of such devices for individuals who need assistance.
Outcome measures
All studies combined reported over 100 unique outcome measures. For only three types of outcome measures, convergent validity is reported [3, 13, 15, 32, 45]. More than 40% percent of the papers rated eleven or higher, putting them in the upper ranges of our BES definition. This indicates that the low evidence levels found during our BES are mainly due to the lack of reported outcome measures with convergent validity and the large diversity of device types and not due to the quality of the studies.
The Lyapunov exponent (λ) is a widely accepted method of assessing gait stability [45]. The short-range λ has reported construct and predictive validity in models and convergent validity in experiments [3, 15]. In our review, it was reported in ten papers but was calculated over 15 unique parameters. This disparity in implementation and calculation was similarly concluded in a dedicated review by Mehdizadeh et al. (2018) [15]. We support their call for a standardisation of λ measurement and calculation across the field, for example, the Lyapunov exponent (λ) of the ML CoM position.
Kinematic variability is frequently used to assess gait stability [3, 14]. A reduction in variability, e.g. σSW, is correlated with an improvement in gait stability [13, 110]. Nevertheless, evidence against a correlation between σSW and dynamic stability is also reported [59]. Step width variability and step length variability are among the most reported outcome measures in our study. Interestingly, these are hardly reported in studies assessing devices for the upper and lower extremities. One hypothesis is that studies regarding more traditional gait aid devices (i.e. canes, walkers, AFOs) are more focused on clinical outcome measures. This hypothesis is indirectly supported by the fact that the clinical measure walking speed is, conversely, almost never reported in the Trunk and Pelvis groups. As σSW is widely accepted and relatively easy to measure and calculate, we implore colleagues in the field to always report σSW, or publish related raw data.
Even though MoS is an old [7] and widely used measure—it is among the most reported in our study—convergent validity in experimental studies seems to be lacking [3, 32, 37, 38] and differences in methodology and interpretation still seem to hinder comparison between studies [20].
Preregistration of studies
In the pool of included studies, the number of papers with a preregistered protocol and outcome measures is very low (< 6%). The absence of preregistration potentially allows researchers to change reported outcome measures after the data is retrieved, increasing the risk of p-hacking and cherry-picking [113, 114]. With websites such as https://osf.io/ [115] the process is fairly straightforward. Thus, we advise researchers to take this step into account before performing their study.
Limitations
Gait stability is a wide term encompassing the human ability to recover from 1) minor cyclic perturbations that occur every step, 2) large perturbations that require a change in overall walking pattern, and 3) the largest recoverable perturbation [3]. In our study, we focused mainly on minor perturbations.
During our analyses, we grouped devices based on the main point of application of their forces and their directions. Such a simplification is insufficient to fully describe how a device works regarding weight shifting, postural restrictions, and even a perceived sense of safety. Regardless, some grouping was required to provide a broad view of the sensitivity of gait stability to forces applied across varying points of applications. Additionally, when running simulations of gait manipulations, for instance in SCONE [116], the effect of a particular added force or moment is similarly distilled into a single point or segment of application, respectively.
Not all studies primarily aimed at gait stability manipulation, or used the term ‘gait stability’, which likely influenced their choice in reported outcome measures and influenced their comparability. Similarly, grouping all impaired subjects for the comparisons within each device type limits the strength of the conclusions that can be drawn. However, the presented cross-disorder conclusions on the direction of devices can still be justified, as we specifically looked at studies containing a baseline and direct intervention measurement.
Outlook
Our main findings can possibly be translated into further improvement of rehabilitation devices and aids. For instance, the evidence surrounding lateral stabilisation of the pelvis could be used in concert with the pelvis-manipulating active device MUCDA [117] or with cold-gas thrusters [25] to provide lateral damping forces. Similarly, the finding that walkers seem to cause a reduction in gait stability could warrant further investigation into the long-term effects of walker use.
Comparison among devices is hindered by the absence of a gold standard and the heterogeneity of the reported outcome measures. We advise using at least (one of) the following outcome measures: short-range Lyapunov exponent (λ), step width variability (σSW), and whole-body centroidal angular momentum (Hr). Furthermore, we implore researchers to preregister their trials to reduce the risk of cherry-picking and to share original data that would allow them to recalculate the above-mentioned outcome measures.
Conclusion
The best evidence synthesis found at most moderate evidence for any intervention. A moderate level of evidence was found for direct improvement of gait stability due to mediolateral pelvis manipulation for non-impaired subjects. Torques applied to the hip joint, and walking poles, sticks, canes and crutches only showed limited evidence for improving gait stability for impaired subjects. Promising, indicative evidence was found for torques applied to the trunk. Moderate and indicative evidence was found for reducing gait stability for walkers for impaired and non-impaired subjects, respectively. Our findings also highlight the lack of consensus on outcome measures amongst studies of devices focused on manipulating gait.
Supporting information
S1 Appendix. Search strategy.
The full search strategy for each database can be found in this supporting document.
https://doi.org/10.1371/journal.pone.0305564.s001
S1 Table. Quality and risk of bias assessment tool.
The modified NIH quality and risk of bias assessment tool can be found here.
https://doi.org/10.1371/journal.pone.0305564.s002
S2 Table. Quality and risk of bias scores.
The full results of the quality and risk of bias assessment tool, for each article, can be found here.
https://doi.org/10.1371/journal.pone.0305564.s003
S1 Checklist. PRISMA 2009 checklist.
https://doi.org/10.1371/journal.pone.0305564.s004
Acknowledgments
The authors wish to thank M.F.M. Engel, from the Erasmus MC Medical Library, for developing and updating the search strategies. Additionally, we wish to thank Dr. S.M. Bruijn from the VU Amsterdam, for his advice on gait stability outcome measures.
Citation: Sterke B, Jabeen S, Baines P, Vallery H, Ribbers G, Heijenbrok-Kal M (2024) Direct biomechanical manipulation of human gait stability: A systematic review. PLoS ONE 19(7): e0305564. https://doi.org/10.1371/journal.pone.0305564
About the Authors:
Bram Sterke
Contributed equally to this work with: Bram Sterke, Saher Jabeen
Roles: Conceptualization, Data curation, Formal analysis, Methodology, Visualization, Writing – original draft
E-mail: [email protected]
Affiliation: Rehabilitation Medicine, Erasmus Medical Center, Rotterdam, The Netherlands
ORICD: https://orcid.org/0000-0003-4869-3304
Saher Jabeen
Contributed equally to this work with: Bram Sterke, Saher Jabeen
Roles: Conceptualization, Data curation, Formal analysis, Methodology, Visualization, Writing – original draft
Affiliation: Department of Biomechanical Engineering, Technical University of Delft, Delft, The Netherlands
Patricia Baines
Roles: Formal analysis, Visualization, Writing – original draft
Affiliation: Department of Biomechanical Engineering, Technical University of Delft, Delft, The Netherlands
Heike Vallery
Roles: Conceptualization, Funding acquisition, Supervision, Writing – review & editing
Affiliations: Rehabilitation Medicine, Erasmus Medical Center, Rotterdam, The Netherlands, Department of Biomechanical Engineering, Technical University of Delft, Delft, The Netherlands
Gerard Ribbers
Roles: Conceptualization, Funding acquisition, Writing – review & editing
Affiliations: Rehabilitation Medicine, Erasmus Medical Center, Rotterdam, The Netherlands, Rijndam Rehabilitation Center, Rotterdam, The Netherlands
ORICD: https://orcid.org/0000-0002-6114-349X
Majanka Heijenbrok-Kal
Roles: Conceptualization, Methodology, Supervision, Writing – review & editing
Affiliations: Rehabilitation Medicine, Erasmus Medical Center, Rotterdam, The Netherlands, Rijndam Rehabilitation Center, Rotterdam, The Netherlands
ORICD: https://orcid.org/0000-0002-2982-4404
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Abstract
People fall more often when their gait stability is reduced. Gait stability can be directly manipulated by exerting forces or moments onto a person, ranging from simple walking sticks to complex wearable robotics. A systematic review of the literature was performed to determine: What is the level of evidence for different types of mechanical manipulations on improving gait stability? The study was registered at PROSPERO (CRD42020180631). Databases Embase, Medline All, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, and Google Scholar were searched. The final search was conducted on the 1st of December, 2022. The included studies contained mechanical devices that influence gait stability for both impaired and non-impaired subjects. Studies performed with prosthetic devices, passive orthoses, and analysing post-training effects were excluded. An adapted NIH quality assessment tool was used to assess the study quality and risk of bias. Studies were grouped based on the type of device, point of application, and direction of forces and moments. For each device type, a best-evidence synthesis was performed to quantify the level of evidence based on the type of validity of the reported outcome measures and the study quality assessment score. Impaired and non-impaired study participants were considered separately. From a total of 4701 papers, 53 were included in our analysis. For impaired subjects, indicative evidence was found for medio-lateral pelvis stabilisation for improving gait stability, while limited evidence was found for hip joint assistance and canes. For non-impaired subjects, moderate evidence was found for medio-lateral pelvis stabilisation and limited evidence for body weight support. For all other device types, either indicative or insufficient evidence was found for improving gait stability. Our findings also highlight the lack of consensus on outcome measures amongst studies of devices focused on manipulating gait.
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