SPiRE Maestro Hand Exoskeleton for Rehabilitation Post Stroke

NCT ID: NCT04978467

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-03

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will experience all controller conditions.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single arm

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.

Group Type EXPERIMENTAL

Exoskeleton

Intervention Type DEVICE

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.

Interventions

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Exoskeleton

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Na Jin Seo, PhD MS BS

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center, Charleston, SC

Locations

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Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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A3869-P

Identifier Type: -

Identifier Source: org_study_id

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