Comparing two hand-assist methods to change index-finger extension after stroke
Assistance Delivery and Muscle Coordination
This project will test two types of hand assistance to see if they change finger movement and muscle activity in people with chronic stroke and in people without stroke.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | The Catholic University of America Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT07011173 on ClinicalTrials.gov |
What this trial studies
This early-phase experiment compares two ways to assist index-finger extension—an end-effector actuator and an exotendon device—in 15 chronic stroke survivors and 15 control participants. Participants perform finger extension movements while motion capture and surface electromyography record kinematics and muscle activation of key forearm and hand muscles. For each assistance type, unassisted movements are performed before and after assistance, and participants are randomized to the order of assistance delivery. The protocol is designed to detect immediate changes in movement and coordination rather than long-term rehabilitation effects.
Who should consider this trial
Good fit: Adults aged 18–70 with a first-ever unilateral cortical stroke at least 6 months earlier, moderate upper-limb impairment (Fugl-Meyer UE score 31–55), retained voluntary finger movement, and ability to travel to the research site are ideal candidates.
Not a fit: People with severe medical illness, pain in the hand or arm, loss of voluntary finger control, musculoskeletal injuries or severe cardiovascular disease, or those unable to provide informed consent are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the findings could help identify better ways to deliver mechanical assistance to improve finger extension and muscle coordination after stroke.
How similar studies have performed: Previous work shows robotic and exotendon devices can assist hand movement after stroke, but direct head-to-head comparisons with detailed muscle recordings are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for stroke survivors: * Age: 18 - 70 years old * First-ever unilateral cortical stroke with resultant hemiparesis at least 6 months prior to the experimental testing * Fugl-Meyer Upper Extremity Section 31 - 55 Exclusion Criteria for both stroke and control: * Presence of concurrent severe medical illness * Pain in hand or arm with movements * Loss of voluntary control of fingers and thumb * Inability to provide informed consent * Musculoskeletal injuries (e.g., fracture) or medical complications (e.g., severe cardiovascular disease).
Where this trial is running
Washington D.C., District of Columbia
- Catholic University of America — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Study coordinator: Sang Wook Lee, PhD
- Email: leesw@cua.edu
- Phone: 202-319-6218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.