Recruiting

Early Phase 1

End-Effector & ExotendonAssistance Delivery and Muscle Coordination

Sponsor:

The Catholic University of America

Code:

NCT07011173

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

Exotendon assistance

End-effector assistance

Study Details

Brief summary:

The experiment will be conducted with 15 chronic stroke survivors and 15 control subjects. Subjects will perform extension movements of the index finger of their more-impaired (stroke) or nondominant (control) hand under two different assistance types: end-effector assistance and exotendon assistance. For each assistance type, unassisted movements will be performed before and after the assistance. Subjects will be randomly assigned into two groups (A and B), who will receive the assistance in a different order. The finger movements and muscle activation patterns will be recorded during movements.

Conditions

Stroke

Study ID

NCT07011173

Start date

Nov 21, 2024

Status verified date

Jul, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: End-effector assistance followed by exotendon assistance

experimental: Exotendon assistance followed by end-effector assistance

Interventions

Exotendon assistance

Assistive devices with distinct assistance dynamics

End-effector assistance

Finger will be moved by the actuators connected to the fingertip

Primary outcome measure

Muscle activation pattern [ Time Frame: Periprocedural ]

Central Contacts and Locations

Central contacts

Sang Wook Lee, PhD

202-319-6218 leesw@cua.edu

Locations

Catholic University of America

Recruiting

Washington D.C., District of Columbia, United States, 20064

Contacts

Sang Wook Lee, PhD

312-608-8001 leesw@cua.edu

More Information

Sponsor

The Catholic University of America

Last update posted

Jul 15, 2026

Last verified

Jul, 2025

Keywords

Stroke
Muscle coordination
Assistance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Catholic University of America on 2026-07-15.