The General Use of Robots in Stroke Recovery: the Anklebot

Study Overview
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Brief Summary
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The purpose of this study is to determine if isolated robot-assisted training of the ankle joint improves chronic hemiparetic gait in patients after stroke.

Official Title
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The General Use of Robots in Stroke Recovery: the Anklebot

Conditions
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Stroke

Intervention / Treatment
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* Device: seated robot-assisted ankle therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior Cognitive function sufficient enough to understand experiments and follow instructions Some amount of independent ambulation (with orthoses or walker) Exclusion Criteria: Botox treatment within 6-weeks of enrollment; Fixed contraction deformity in the affected limb; Complete and total flaccid paralysis of all lower extremity motor function; Unable to ambulate except with the aid of another person

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects received 18 sessions (3 times per week for 6 weeks) of seated robotic ankle training. Upon analysis, subjects were stratified by average admission gait speed on the 10 Meter Walk Test at comfortable pace, according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) gait functioning.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: seated robot-assisted ankle therapy<br>All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated robot-assisted ankle training with the MIT anklebot. Upon analysis, subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning. | Device: seated robot-assisted ankle therapy<br>* The MIT anklebot provides over one thousand total dorsi/plantar flexion and inversion/eversion robot-assisted movements of the ankle while in a seated position.<br>* Other names: Massachusetts Insititute of Technology (MIT) Anklebot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace. | Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)). | baseline, discharge (week 6), 3 month FU (overall week 18) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace. | Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at fast pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)). | baseline, discharge (week 6), 3 month FU (overall week 18) | 
| Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace. | Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning. Mean distance walked (m) on the 6 Minute Walk test at comfortable pace were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)). | baseline, discharge (week 6), 3 month FU (overall week 18) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, CVA, cerebrovascular accident, cerebral stroke, robotic therapy, anklebot, physical therapy