SPiRE Maestro Hand Exoskeleton for Rehabilitation Post Stroke

Not Applicable

Withdrawn

• Conditions: Stroke
• Interventions: Device: Exoskeleton

• Registration Number: NCT04978467
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The research team will develop a novel training tool to improve finger joint coordination, to address the unmet need in the current rehabilitation, thereby enhancing hand function and contributing to improved independence and quality of life for Veterans with stroke.

Detailed Description

The research team will determine feasibility of training using CA and TA controllers in subacute stroke. Specifically, we will examine if joint coordination improves over a training session. The investigators will compare the extent of improvement for each controller and impairment severity.

Study Timeline

• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-27
• Study Start: 2024-09-03
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Adult Veterans with a stroke 1-6 months ago
• Ability to move fingers (Chedoke-McMaster Hand Section Stage 2-4)

Exclusion Criteria

• Inability to follow 2-step commands
• Severe muscle tone prohibiting proper placement of the fingers (Modified Ashworth Scale, MAS=5 out of 5)
• Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Exoskeleton	All participants will receive assistance to move finger joints away from the compensatory coordination (compensation avoidance), toward the desired trajectories (task assistance), both, and none in different days.

Primary Outcome Measures

Name	Time	Method
change in finger joint torque assistance	from the 1st half to the 2nd half of the 1-hour training session	Change in finger joint torque assistance needed from the 1st half to the 2nd half of the 1-hour training session. Reduction in torque is considered a good outcome. There is no predefined minimum/maximum.

Trial Locations

Locations (1)

Ralph H. Johnson VA Medical Center, Charleston, SC; 🇺🇸 Charleston, South Carolina, United States