Evaluation of a Wearable Exoskeleton for Functional Arm Training

Not Applicable

Completed

• Conditions: Post-Stroke Hemiparesis; Stroke
• Interventions: Other: Gravity Elimination Alone; Other: Path Assistance Alone; Other: Path Assistance and Gravity Elimination

• Registration Number: NCT02726204
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can assist task performance during 3D arm movement tasks under various experimental conditions in healthy individuals and patients with stroke. This study is designed to test motor learning with the robotic rehabilitative device CAREX under three conditions in healthy subjects and subjects with post-stroke hemiparesis.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-28
• Study First Posted: 2016-04-01
• Primary Completion: 2016-05-05
• Study Completion: 2016-05-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	Path Assistance Alone	Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance.
Healthy Subjects	Gravity Elimination Alone	Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance.
Chronic Post Stroke Right Side Hemiparesis	Gravity Elimination Alone	Radiologically verified unilateral stroke patients with at least 4 months previously.
Chronic Post Stroke Right Side Hemiparesis	Path Assistance and Gravity Elimination	Radiologically verified unilateral stroke patients with at least 4 months previously.
Chronic Post Stroke Right Side Hemiparesis	Path Assistance Alone	Radiologically verified unilateral stroke patients with at least 4 months previously.
Healthy Subjects	Path Assistance and Gravity Elimination	Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance.

Primary Outcome Measures

Name	Time	Method
Upper extremity motor impairment measured by performance on the 33 tasks of the Fugl-Meyer Scale (FMS)	1 Day
Passive range of motion measured by goniometry	1 Day
Active range of motion measured by goniometry	1 Day
Spasticity measured by the Modified Ashworth Scale (MAS)	1 Day

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States