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.
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.
United States1 site, 1 recruiting
- Recruiting
Catholic University of America
Washington D.C., District of Columbia, 20064
Sang Wook Lee, PhD, 312-608-8001, leesw@cua.edu
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
- 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.
- 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.
- 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°).
- 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).
- 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 group | Role | What they receive |
|---|---|---|
| End-effector assistance followed by exotendon assistance | Experimental | Not described Receives: Device: Exotendon assistance; Device: End-effector assistance |
| Exotendon assistance followed by end-effector assistance | Experimental | Not 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.
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.
- First posted8 Jun 2025
- Study start21 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Catholic University of America
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistance Delivery and Muscle Coordination
- ClinicalTrials.gov ID
- NCT07011173
- Acronym / sponsor ID
- STUDY00006784
- Conditions
- Stroke
- Keywords
- Stroke, Muscle coordination, Assistance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Catholic University of AmericaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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°).
- 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).
- 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End-effector assistance followed by exotendon assistance | Experimental | Device: Exotendon assistance, Device: End-effector assistance |
| Exotendon assistance followed by end-effector assistance | Experimental | Device: Exotendon assistance, Device: End-effector assistance |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exotendon assistanceAssistive devices with distinct assistance dynamics | Device | End-effector assistance followed by exotendon assistance, Exotendon assistance followed by end-effector assistance |
| End-effector assistanceFinger will be moved by the actuators connected to the fingertip | Device | End-effector assistance followed by exotendon assistance, Exotendon assistance followed by end-effector assistance |
Primary outcome
Muscle activation pattern
Time frame: Periprocedural
Coordination of different hand muscles
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Undecided. The investigators have not decided how and which part of the data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.