SPiRE Maestro Hand Exoskeleton for Rehabilitation Post Stroke

November 1, 2024 updated by: VA Office of Research and Development

Feasibility of Using Maestro Hand Exoskeleton in Post-stroke Hand Rehabilitation to Improve Joint Coordination

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5703
        • Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in finger joint torque assistance
Time Frame: 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.
from the 1st half to the 2nd half of the 1-hour training session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Na Jin Seo, PhD MS BS, Ralph H. Johnson VA Medical Center, Charleston, SC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3869-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Due to the small sample size, individual data that are de-identified will be presented in publications.

IPD Sharing Time Frame

De-identified individual data that are presented in publications will be available as long as the publications are available.

IPD Sharing Access Criteria

Journals' access criteria.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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