The General Use of Robots in Stroke Recovery: the Anklebot

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: seated robot-assisted ankle therapy

• Registration Number: NCT02249832
• Lead Sponsor: Northwell Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-26
• Primary Completion: 2019-02
• Study Completion: 2019-05
• Results First Submitted: 2019-09-25
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-13
• Results First Posted: 2019-11-15
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
seated robot-assisted ankle therapy	seated robot-assisted ankle therapy	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.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.	baseline, discharge (week 6), 3 month FU (overall week 18)	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)).

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.	baseline, discharge (week 6), 3 month FU (overall week 18)	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)).
Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.	baseline, discharge (week 6), 3 month FU (overall week 18)	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)).

Trial Locations

Locations (2)

Feinstein Institutes for Medical Research; 🇺🇸 Manhasset, New York, United States

Transitions of Long Island Outpatient Rehabilitation; 🇺🇸 Manhasset, New York, United States