The General Use of Robots in Stroke Rec… | Clinical Trial

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Feinstein Institutes for Medical Research, Manhasset, New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

seated robot-assisted ankle therapy

Device

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.

Other names: Massachusetts Insititute of Technology (MIT) Anklebot

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.

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 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.

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 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)).

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2019
Study completion: 2019
First posted: Sep 26, 2014
Registry last updated: Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed