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Clinical Trials/NCT02249832
NCT02249832
Completed
Not Applicable

The General Use of Robots in Stroke Recovery: the Anklebot

Northwell Health2 sites in 1 country55 target enrollmentJune 2013
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Northwell Health
Enrollment
55
Locations
2
Primary Endpoint
Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
May 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bruce Volpe

Principal Investigator

Northwell Health

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.

Time Frame: 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 Outcomes

  • 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))
  • 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))

Study Sites (2)

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