SPiRE Maestro Hand Exoskeleton for Rehabilitation Post Stroke

NCT04978467 | Withdrawn DMC

• 1 other identifier: A3869-P
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Soft Robotics; Robotic Exoskeleton; Neurologic Rehabilitation; Physical Medicine and Rehabilitation; Rehabilitation Exercise

Outcome Measures

Primary Outcomes (1)

• change in finger joint torque assistance

  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

Study Arms (1)

single arm

EXPERIMENTAL

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

Interventions

Exoskeleton 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.

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Na Jin Seo, PhD MS BS

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: All participants will experience all controller conditions.

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 27, 2021
• Study Start: September 3, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified individual data that are presented in publications will be available as long as the publications are available.
• Access Criteria: Journals' access criteria.

Locations

US (1)