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StrokeEarly Phase 1NCT07011173

Assistance Delivery and Muscle Coordination

A Early Phase 1 study testing Exotendon assistance and End-effector assistance in people with Stroke, run by The Catholic University of America at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Exotendon assistance and End-effector assistance
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
21 Nov 2024to 31 Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sang Wook Lee, PhD contact

202-319-6218

leesw@cua.edu

United States1 site, 1 recruiting
  • Catholic University of America

    Washington D.C., District of Columbia, 20064

    Sang Wook Lee, PhD, 312-608-8001, leesw@cua.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description
  1. Pre-experimental session: First, reflective markers will be placed on the dorsum of the hand, i.e., metacarpophalangeal (MCP) and distal/proximal interphalangeal (DIP/PIP) joints of the index finger, index fingertip, MCP of the little finger, and carpometacarpal joint of the middle finger, which will be used to establish a local coordinate system. ten-camera motion capture system (Optitrak Prime X13; NaturalPoint Inc., OR, USA) will be used to record the finger movements. Bipolar surface electrodes (Myosystem 14; Noraxon Inc., Scottsdale, AZ) will be placed to record the activity of the following muscles: extensor digitorum communis (EDC), flexor digitorum superficialis (FDS), first dorsal interosseous (FDI), first palmar interosseous (FPI), extensor carpi radialis (ECR), and flexor carpi radialis (FCR) muscles. Once the reflective markers and the electromyography (EMG) electrodes are attached, subjects will place their hand in the device. Their forearm will be secured once a comfortable wrist posture for each subject is determined. The location of the pulleys and linear guides will be adjusted to accommodate the forearm posture, determined by the subject-specific wrist angle. Once the fingertip is secured to the end-effector actuator, whose location will then be fixed/locked, they will perform maximum contraction (3-second) of the following muscles, extensor digitorum communis (EDC), flexor digitorum superficialis (FDS), first dorsal interosseous (FDI), extensor carpi radialis (ECR), and flexor carpi radialis (FCR) by performing finger extension, finger flexion, finger abduction, wrist extension, and wrist flexion, during which maximum EMG signals for the target muscles will be obtained. Rest periods of minimum 30-second (or as needed) will be administered between contractions. The fingertip will then be disconnected from the end-effector.
  2. Experimental session (1,2):

After rest, subjects will perform finger extension movements with and without assistance. In each session, finger extension task will be performed without assistance in the block 1 (10 trials), followed by the assisted finger extension in the block 2 (15 trials). In the block 3, unassisted finger extension will be performed to gauge residual impact of the motor adaptation by assistance (Fig. 1B).

For group A, session 1 (end-effector assistance) will first be tested, followed by session 2 (exotendon assistance); for group B, the session 2 will be first implemented.

  1. Unassisted finger extension: Subjects will extend their index finger from the initial posture (approximately MCP: 45°; PIP: 60°; DIP: 45°) to the fully-extended posture (all angles = 0°).
  2. Assisted finger extension (end-effector): The two linear motors will be coordinated to produce a smooth fingertip trajectory for the finger extension. A custom MATLAB program will generate the time-varying movement profiles of the two linear motors that produce the desired fingertip trajectory for each subject in 3 seconds, which are computed from each subject's segment lengths and initial/final postures of the finger extension movement (forward kinematics).
  3. Assisted finger extension (exotendon): The two exotendons (extrinsic extensor and intrinsic cables; Fig. 2) will be pulled to assist finger extension movement. Actuation speed of the two linear motors, pulling the extrinsic extensor exotendon (mimicking EDC action) and the intrinsic exotendon (mimicking FDI/FPI action), will be determined from the total excursion of the two exotendons during extension movement, which depends on the subject's finger thickness (i.e., moment arms of the exotendons). The motor speed will be adjusted so that the finger extension movement can be completed in 3 seconds.

In all conditions, a graphical user interface (MATLAB toolbox) will display a timing bar that indicates the timing of the movement initiation and completion (duration: 3 seconds).

Conditions
Stroke
Being tested
Exotendon assistance, End-effector assistance
Keywords
Stroke, Muscle coordination, Assistance
Medical subject headings
Stroke, Helping Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exotendon assistanceDevice

    Assistive devices with distinct assistance dynamics

  • End-effector assistanceDevice

    Finger will be moved by the actuators connected to the fingertip

Study groups in NCT07011173
Study groupRoleWhat they receive
End-effector assistance followed by exotendon assistanceExperimentalNot described
Receives: Device: Exotendon assistance; Device: End-effector assistance
Exotendon assistance followed by end-effector assistanceExperimentalNot described
Receives: Device: Exotendon assistance; Device: End-effector assistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle activation pattern

    Coordination of different hand muscles

    Measured: Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2025
  2. Study start21 Nov 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07011173
Sponsor's protocol ID
STUDY00006784
Other IDs
1R15HD114052
Status last verified
Jul 2025
First submitted
29 May 2025
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The investigators have not decided how and which part of the data will be shared.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Exotendon assistance and End-effector assistance in people with Stroke, run by The Catholic University of America at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sang Wook Lee, PhD (202-319-6218, leesw@cua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle activation pattern (time frame: Periprocedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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