Dataset Information

Effect of assist-as-needed robotic gait training on the gait pattern post stroke: a randomized controlled trial.

ABSTRACT:

Background

Regaining gait capacity is an important rehabilitation goal post stroke. Compared to clinically available robotic gait trainers, robots with an assist-as-needed approach and multiple degrees of freedom (AAN_mDOF) are expected to support motor learning, and might improve the post-stroke gait pattern. However, their benefits compared to conventional gait training have not yet been shown in a randomized controlled trial (RCT). The aim of this two-center, assessor-blinded, RCT was to compare the effect of AAN_mDOF robotic to conventional training on the gait pattern and functional gait tasks during post-stroke inpatient rehabilitation.

Methods

Thirty-four participants with unilateral, supratentorial stroke were enrolled (mDOF robotic (combination of training in LOPES-II and conventional gait training) or conventional gait training (30 min, 3-5 times a week), focused on pre-defined training goals. Randomization and allocation to training group were carried out by an independent researcher. External mechanical work (W_EXT), spatiotemporal gait parameters, gait kinematics related to pre-defined training goals, and functional gait tasks were assessed before training (T0), after training (T1), and at 4-months follow-up (T2).

Results

Two participants, one in each group, were excluded from analysis because of discontinued participation after T0, leaving 32 participants (AAN_mDOF robotic n?=?17; conventional n?=?15) for intention-to-treat analysis. In both groups, W_EXT had decreased at T1 and had become similar to baseline at T2, while gait speed had increased at both assessments. In both groups, most spatiotemporal gait parameters and functional gait tasks had improved at T1 and T2. Except for step width (T0-T1) and paretic step length (T0-T2), there were no significant group differences at T1 or T2 compared to T0. In participants with a pre-defined goal aimed at foot clearance, paretic knee flexion improved more in the AAN_mDOF robotic group compared to the conventional group (T0-T2).

Conclusions

Generally, AAN_mDOF robotic training was not superior to conventional training for improving gait pattern in subacute stroke survivors. Both groups improved their mechanical gait efficiency. Yet, AAN_mDOF robotic training might be more effective to improve specific post-stroke gait abnormalities such as reduced knee flexion during swing. Trial registration Registry number Netherlands Trial Register ( www.trialregister.nl ): NTR5060. Registered 13 February 2015.

SUBMITTER: Alingh JF

PROVIDER: S-EPMC7863532 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Effect of assist-as-needed robotic gait training on the gait pattern post stroke: a randomized controlled trial.

Alingh J F JF Fleerkotte B M BM Groen B E BE Rietman J S JS Weerdesteyn V V van Asseldonk E H F EHF Geurts A C H ACH Buurke J H JH

Journal of neuroengineering and rehabilitation 20210205 1

<h4>Background</h4>Regaining gait capacity is an important rehabilitation goal post stroke. Compared to clinically available robotic gait trainers, robots with an assist-as-needed approach and multiple degrees of freedom (AAN<sub>mDOF</sub>) are expected to support motor learning, and might improve the post-stroke gait pattern. However, their benefits compared to conventional gait training have not yet been shown in a randomized controlled trial (RCT). The aim of this two-center, assessor-blinde ...[more]

PMID: 33546733

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Project description:Understanding the reorganization of the central nervous system after stroke is an important endeavor in order to design new therapies in gait training for stroke patients. Current clinical evaluation scores and gait velocity are insufficient to describe the state of the nervous system, and one aspect where this is lacking is in the quantification of gait symmetry. Previous studies have pointed out that spatiotemporal gait asymmetries are commonly observed in stroke patients with hemiparesis. Such asymmetries are known to cause long-term complications like joint pain and deformation. Recent studies also indicate that spatiotemporal measures showed that gait symmetry worsens after discharge from therapy. This study shows that muscle synergy analysis can be used to quantify gait symmetry and compliment clinical measures. Surface EMG was collected from lower limb muscles of subacute post-stroke patients (with an onset of around 14 days) from two groups, one undergoing robotic-assisted therapy (known as HAL group) and the other undergoing conventional therapy (known as Control group). Muscle synergies from the paretic and non-paretic limb were extracted with Non-Negative Matrix Factorization (NNMF) and compared with each other to obtain a gait symmetry index over therapy sessions. Gait events were tracked with motion tracking (for the HAL group) or foot pressure sensors (for the conventional therapy group). Patients from both groups were assessed over a 3-weeks long gait training program. Results indicated that there were no differences in muscle synergy symmetry for both groups of patients. However, the timing of muscle synergies were observed to be symmetrical in the HAL group, but not for the Control group. Intergroup comparisons of symmetry in muscle synergies and their timings were not significantly different. This could be due to a large variability in recovery in the Control group. Finally, stance time ratio was not observed to improve in both groups after their respective therapies. Interestingly, FIM and FMA scores of both groups were observed to improve after their respective therapies. Analysis of muscle coordination could reveal mechanisms of gait symmetry which could otherwise be difficult to observe with clinical scores.

Project description:BackgroundRobotic-Assisted Gait Training (RAGT) may enable high-intensive and task-specific gait training post-stroke. The effect of RAGT on gait movement patterns has however not been comprehensively reviewed. The purpose of this review was to summarize the evidence for potentially superior effects of RAGT on biomechanical measures of gait post-stroke when compared with non-robotic gait training alone.MethodsNine databases were searched using database-specific search terms from their inception until January 2021. We included randomized controlled trials investigating the effects of RAGT (e.g., using exoskeletons or end-effectors) on spatiotemporal, kinematic and kinetic parameters among adults suffering from any stage of stroke. Screening, data extraction and judgement of risk of bias (using the Cochrane Risk of bias 2 tool) were performed by 2-3 independent reviewers. The Grading of Recommendations Assessment Development and Evaluation (GRADE) criteria were used to evaluate the certainty of evidence for the biomechanical gait measures of interest.ResultsThirteen studies including a total of 412 individuals (mean age: 52-69 years; 264 males) met eligibility criteria and were included. RAGT was employed either as monotherapy or in combination with other therapies in a subacute or chronic phase post-stroke. The included studies showed a high risk of bias (n = 6), some concerns (n = 6) or a low risk of bias (n = 1). Meta-analyses using a random-effects model for gait speed, cadence, step length (non-affected side) and spatial asymmetry revealed no significant differences between the RAGT and comparator groups, while stride length (mean difference [MD] 2.86 cm), step length (affected side; MD 2.67 cm) and temporal asymmetry calculated in ratio-values (MD 0.09) improved slightly more in the RAGT groups. There were serious weaknesses with almost all GRADE domains (risk of bias, consistency, directness, or precision of the findings) for the included outcome measures (spatiotemporal and kinematic gait parameters). Kinetic parameters were not reported at all.ConclusionThere were few relevant studies and the review synthesis revealed a very low certainty in current evidence for employing RAGT to improve gait biomechanics post-stroke. Further high-quality, robust clinical trials on RAGT that complement clinical data with biomechanical data are thus warranted to disentangle the potential effects of such interventions on gait biomechanics post-stroke.

Project description:BackgroundStroke is a leading cause of serious gait impairments and restoring walking ability is a major goal of physical therapy interventions. Soft robotic exosuits are portable, lightweight, and unobtrusive assistive devices designed to improve the mobility of post-stroke individuals through facilitation of more natural paretic limb function during walking training. However, it is unknown whether long-term gait training using soft robotic exosuits will clinically impact gait function and quality of movement post-stroke.ObjectiveThe objective of this pilot study was to examine the therapeutic effects of soft robotic exosuit-augmented gait training on clinical and biomechanical gait outcomes in chronic post-stroke individuals.MethodsFive post-stroke individuals received high intensity gait training augmented with a soft robotic exosuit, delivered in 18 sessions over 6-8 weeks. Performance based clinical outcomes and biomechanical gait quality parameters were measured at baseline, midpoint, and completion.ResultsClinically meaningful improvements were observed in walking speed ([Formula: see text] < 0.05) and endurance ([Formula: see text] < 0.01) together with other traditional gait related outcomes. The gait quality measures including hip ([Formula: see text] < 0.01) and knee ([Formula: see text] < 0.05) flexion/extension exhibited an increase in range of motion in a symmetric manner ([Formula: see text] < 0.05). We also observed an increase in bilateral ankle angular velocities ([Formula: see text] < 0.05), suggesting biomechanical improvements in walking function.ConclusionsThe results in this study offer preliminary evidence that a soft robotic exosuit can be a useful tool to augment high intensity gait training in a clinical setting. This study justifies more expanded research on soft exosuit technology with a larger post-stroke population for more reliable generalization. Trial registration This study is registered with ClinicalTrials.gov (ID: NCT04251091).

Project description:ObjectivesTo assess the effect of a home-based over-ground robotic-assisted gait training program using the AlterG Bionic Leg orthosis on clinical functional outcomes in people with chronic stroke.DesignRandomized controlled trial.SettingHome.ParticipantsThirty-four ambulatory chronic stroke patients who recieve usual physiotherapy.InterventionUsual physiotherapy plus either (1)10-week over-ground robotic-assisted gait training program (n = 16), using the device for ⩾30 minutes per day, or (2) control group (n = 18), 30 minutes of physical activity per day.MeasurementsThe primary outcome was the Six-Minute Walk Test. Secondary outcomes included: Timed-Up-and-Go, Functional Ambulation Categories, Dynamic Gait Index and Berg Balance Scale. Physical activity and sedentary time were assessed using accelerometry. All measurements were completed at baseline, 10 and 22 weeks after baseline.ResultsSignificant increases in walking distance were observed for the Six-Minute Walk Test between baseline and 10 weeks for over-ground robotic-assisted gait training (135 ± 81 m vs 158 ± 93 m, respectively; P ⩽ 0.001) but not for control (122 ± 92 m vs 119 ± 84 m, respectively). Findings were similar for Functional Ambulation Categories, Dynamic Gait Index and Berg Balance Scale (all P ⩽ 0.01). For over-ground robotic-assisted gait training, there were increases in time spent stepping, number of steps taken, number of sit-to-stand transitions, and reductions in time spent sitting/supine between baseline and 10 weeks (all P < 0.05). The differences observed in all of the aforementioned outcome measures were maintained at 22 weeks, 12 weeks after completing the intervention (all P > 0.05).ConclusionOver-ground robotic-assisted gait training combined with physiotherapy in chronic stroke patients led to significant improvements in clinical functional outcomes and physical activity compared to the control group. Improvements were maintained at 22 weeks.

Project description:BackgroundA novel electromechanical robotic-exoskeleton was designed in-house for the rehabilitation of wrist joint and Metacarpophalangeal (MCP) joint.ObjectiveThe objective was to compare the rehabilitation effectiveness (clinical-scales and neurophysiological-measures) of robotic-therapy training sessions with dose-matched conventional therapy in patients with stroke.MethodsA pilot prospective parallel randomized controlled study at clinical settings was designed for patients with stroke within 2 years of chronicity. Patients were randomly assigned to receive an intervention of 20 sessions of 45 min each, five days a week for four weeks, in Robotic-therapy Group (RG) (n = 12) and conventional upper-limb rehabilitation in Control-Group (CG) (n = 11). We intended to evaluate the effects of a novel exoskeleton based therapy on the functional rehabilitation outcomes of upper-limb and cortical-excitability in patients with stroke as compared to the conventional-rehabilitation. Clinical-scales- Modified Ashworth Scale, Active Range of Motion, Barthel-Index, Brunnstrom-stage and Fugl-Meyer (FM) scale and neurophysiological measures of cortical-excitability (using Transcranial Magnetic Stimulation) -Motor Evoked Potential and Resting Motor threshold, were acquired pre- and post-therapy.ResultsNo side effects were noticed in any of the patients. Both RG and CG showed significant (p < 0.05) improvement in all clinical motor-outcomes except Modified Ashworth Scale in CG. RG showed significantly (p < 0.05) higher improvement over CG in Modified Ashworth Scale, Active Range of Motion and Fugl-Meyer scale and FM Wrist-/Hand component. An increase in cortical-excitability in ipsilesional-hemisphere was found to be statistically significant (p < 0.05) in RG over CG, as indexed by a decrease in Resting Motor Threshold and increase in the amplitude of Motor Evoked Potential. No significant changes were shown by the contralesional-hemisphere. Interhemispheric RMT-asymmetry evidenced significant (p < 0.05) changes in RG over CG indicating increased cortical-excitability in ipsilesional-hemisphere along with interhemispheric changes.ConclusionRobotic-exoskeleton training showed improvement in motor outcomes and cortical-excitability in patients with stroke. Neurophysiological changes in RG could most likely be a consequence of plastic reorganization and use-dependent plasticity. Trial registry number: ISRCTN95291802.

Project description:Post stroke upper limb rehabilitation is a challenging problem with poor outcomes as 40% of survivors have functionally useless upper limbs. Robot-aided therapy (RAT) is a potential method to alleviate the effort of intensive, task-specific, repetitive upper limb exercises for both patients and therapists. The present study aims to investigate how a time matched combinatory training scheme that incorporates conventional and RAT, using H-Man, compares with conventional training toward reducing workforce demands. In a randomized control trial (NCT02188628, www.clinicaltrials.gov), 44 subacute to chronic stroke survivors with first-ever clinical stroke and predominant arm motor function deficits were recruited and randomized into two groups of 22 subjects: Robotic Therapy (RT) and Conventional Therapy (CT). Both groups received 18 sessions of 90 min; three sessions per week over 6 weeks. In each session, participants of the CT group received 90 min of 1:1 therapist-supervised conventional therapy while participants of the RT group underwent combinatory training which consisted of 60 min of minimally-supervised H-Man therapy followed by 30 min of conventional therapy. The clinical outcomes [Fugl-Meyer (FMA), Action Research Arm Test and, Grip Strength] and the quantitative measures (smoothness, time efficiency, and task error, derived from two robotic assessment tasks) were independently evaluated prior to therapy intervention (week 0), at mid-training (week 3), at the end of training (week 6), and post therapy (week 12 and 24). Significant differences within group were observed at the end of training for all clinical scales compared with baseline [mean and standard deviation of FMA score changes between baseline and week 6; RT: Δ4.41 (3.46) and CT: Δ3.0 (4.0); p < 0.01]. FMA gains were retained 18 weeks post-training [week 24; RT: Δ5.38 (4.67) and week 24 CT: Δ4.50 (5.35); p < 0.01]. The RT group clinical scores improved similarly when compared to CT group with no significant inter-group at all time points although the conventional therapy time was reduced to one third in RT group. There were no training-related adverse side effects. In conclusion, time matched combinatory training incorporating H-Man RAT produced similar outcomes compared to conventional therapy alone. Hence, this study supports a combinatory approach to improve motor function in post-stroke arm paresis. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02188628.

Dataset Information

Effect of assist-as-needed robotic gait training on the gait pattern post stroke: a randomized controlled trial.

Background

Methods

Results

Conclusions

Publications

Effect of assist-as-needed robotic gait training on the gait pattern post stroke: a randomized controlled trial.

Similar Datasets

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