N/A N=55 Treatment

The General Use of Robots in Stroke Recovery: the Anklebot

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT02249832 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Nov 2019

Primary outcome: Primary: Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace. — 0.22; 0.53; 1.02; 0.26 m/sec — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: seated robot-assisted ankle therapy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwell Health
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.	0.22; 0.53; 1.02; 0.26; 0.62; 1.18	<0.001 sig
SECONDARY Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.	0.25; 0.67; 1.30; 0.29; 0.79; 1.41	<0.001 sig
SECONDARY Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.	68.46; 152.92; 280.43; 79.33; 180.11; 319.79	0.001 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02249832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.