ClinicalTrials.gg
RecruitingNCT07011173Updated Jul 15, 2026

Assistance Delivery and Muscle Coordination

An Early Phase 1 interventional study of Exotendon assistance and End-effector assistance in Stroke, sponsored by The Catholic University of America. Recruiting at 1 site in United States. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by The Catholic University of America · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2024, registered May 2025).
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,991 studies in Stroke with a site in United States — 394 open to participants now, 490 under way, 17 of them phase 3. Stroke · United States.

Planned enrollment
909th of 1,617
30 · median 40
Started
2024
with 113 others
Phase 1
126 of 1,991
18 open now
Primary completion
2026-12
later than 150 of 488 live
Registered
1,849th of 1,991
by date

Among the 1,991 studies in Stroke with a site in United States, this one is the 909th largest by planned enrollment of the 1,617 interventional ones, is one of 114 that started in 2024, is one of 126 in phase 1, reaches primary completion later than 150 of the 488 other live ones, and was the 1,849th registered.

By phase

1,991 studies; the count open now beside each. This study's row is marked.

No phase1,121 · 272 open
Observational364 · 60 open
Phase 2162 · 21 open
Phase 1this study126 · 18 open
Phase 3100 · 8 open
Phase 1/247 · 5 open
Phase 443 · 5 open
Phase 2/326 · 5 open
Other kind2 · 0 open

By the year they started

First in 1980; this study’s year is marked. 114 started in 2024.

Size and results

Median enrollment 40 across the 1,617 interventional studies, 153 across the 363 observational. Of the 1,327 that completed or were terminated, 561 (42%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 1,991 studies in Stroke with a site in United States, or all of them as a file.
02

Study 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.

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).

03

Conditions studied

  • Stroke

Browse trials for

Keywords

  • Stroke
  • Muscle coordination
  • Assistance
04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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
  • Musculoskeletal injuries (e.g., fracture) or medical complications (e.g., severe cardiovascular disease).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    End-effector assistance followed by exotendon assistance

    Device: Exotendon assistance · Device: End-effector assistance

  • Experimental
    Exotendon assistance followed by end-effector assistance

    Device: Exotendon assistance · Device: End-effector assistance

Interventions

  • DeviceExotendon assistance

    Assistive devices with distinct assistance dynamics

  • DeviceEnd-effector assistance

    Finger will be moved by the actuators connected to the fingertip

06

What researchers measure

Primary outcomes

  1. Muscle activation pattern

    Coordination of different hand muscles

    Time frame: Periprocedural

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — The investigators have not decided how and which part of the data will be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.

Of 71 non-industry phase 1 interventional studies under Stroke, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 25 months is below that.

Counting every sponsor, half of 97 studies reached it within 20 months; a quarter within 7 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2025
First posted
Jun 8, 2025
StartActual
Nov 21, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jul 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07011173
Lead sponsor
The Catholic University of America
Responsible party
Sponsor
First posted
Jun 8, 2025
Start date
Nov 21, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 15, 2026

Study contacts

Sang Wook Lee, PhD
Contact
leesw@cua.edu
202-319-6218

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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