SPiRE Maestro Hand Exoskeleton for Rehabilitation Post Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04978467
• Other study ID #: A3869-P
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: R. Amanda C LaRue, PhD
• Phone: (843) 789-6707
• Email: Rutha.Larue[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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