Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT06655636
Status
Recruiting
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Conditions

  • Cerebral Vascular Accident
  • Stroke

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Device tuned to Assistance — DEVICE
    The device spring components will be tuned to produce an assistive supination torque on the forearm.
  • Device tuned to Sham (Slack Springs) — DEVICE
    The device spring components will be tuned to slack springs to serve as a placebo. The user will think they are receiving forces but in reality the device will not be providing any forces.
  • Device tuned to Anti-Assistance — DEVICE
    The device spring components will be tuned to produce a resistive supination torque on the forearm.

Study Details

The purpose of this study is to evaluate the safety, feasibility, and efficacy of an exoskeletal network of passive, multi-joint springs for forearm supination. Also known as the forearm ExoNET, the device is a passive, robotic device that will properly assist forearm supination in the post-stroke adult population.

Key Dates

Start date
Dec 4, 2024
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 - Assistance, Sham, Anti-Assistance
    Group 1 receives all three interventions in the order of assistance, then sham (slack springs), then anti-assistance. Each intervention corresponds to different settings on the device.
  • Experimental: Group 2 - Sham, Assistance, Anti-Assistance
    Group 2 receives all three interventions in the order of sham (slack springs), then assistance, then anti-assistance. Each intervention corresponds to different settings on the device.

Primary Outcome Measure

Action Research Arm Test (ARAT) [ Time Frame: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60610
Courtney Celian, OTR/L
[email protected]
312-238-1560
James Patton, PhD (PRINCIPAL_INVESTIGATOR)
Valentino I Wilson, MEng (SUB_INVESTIGATOR)
Courtney Celian, OTR/L (SUB_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Shirley Ryan AbilityLab· Chicago, IL

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