StrokeEarly Phase 1NCT07598695
Sensory Feedback and Hand Motor Adaptation
A Early Phase 1 study testing Visual ROM augmentation and Visual ROM reduction in people with Stroke, run by The Catholic University of America at 1 site in United States.
Trial summary
The following experiment will be conducted with 15 chronic stroke survivors and 15 control subjects. Subjects will perform hand movements in the virtual reality environment using a head-mounted display. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Visual ROM augmentation and Visual ROM reduction
- 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
- 1 Oct 2025to 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 20 - 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
Official title: Impact of Altered Sensory Feedback on Adaptation of Hand Muscle Coordination of Stroke Survivors
The following experiment will be conducted with 15 chronic stroke survivors and 15 control subjects. Subjects will perform hand movements in the virtual reality environment using a head-mounted display. Quest's onboard cameras allow real-time tracking of hand motion, estimating joint angles of the finger and the thumb. For each feedback manipulation condition (i.e., movement amplification or reduction), the estimated joint angles will be multiplied by a factor greater than 1 (amplification) or a factor smaller than 1 (reduction). Then the newly-estimated hand posture will be displayed in the VR environment. Subjects will be randomly assigned into two groups (A and B), who will receive the assistance in a different order. Subjects will perform finger extension under three conditions: no sensory modulation, movement visual feedback (VF) amplification, and movement VF reduction (error augmentation), while their movement muscle activation patterns are recorded.
- Conditions
- Stroke
- Being tested
- Visual ROM augmentation, Visual ROM reduction
- Keywords
- Stroke, Muscle coordination, Visual feedback, Hand
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual ROM augmentationDevice
Finger joint ROM is amplified.
Visual ROM reductionDevice
Visual feedback of finger joint ROM is reduced.
| Study group | Role | What they receive |
|---|---|---|
| Visual ROM augmentation followed by visual ROM reduction | Experimental | Not described Receives: Device: Visual ROM augmentation; Device: Visual ROM reduction |
| Visual ROM reduction followed by visual ROM augmentation | Experimental | Not described Receives: Device: Visual ROM augmentation; Device: Visual ROM reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint range of motion (ROM)
range of motion of individual finger joints under each condition, measured by embedded cameras that digitize individual finger segments
Measured: Periprocedural
Secondary outcomes (1)
Muscle activation
Activation level of hand muscles will be measured using surface EMG electrodes attached to the major hand muscles including extensor digitorum communis, flexor digitorum superficialis, and first dorsal interosseous.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Oct 2025
- Primary completion1 Oct 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
- NCT07598695
- Sponsor's protocol ID
- STUDY00006785
- Other IDs
- 1R15HD114052
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share IPD but the de-identified data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Altered Sensory Feedback on Adaptation of Hand Muscle Coordination of Stroke Survivors
- ClinicalTrials.gov ID
- NCT07598695
- Acronym / sponsor ID
- STUDY00006785
- Conditions
- Stroke
- Keywords
- Stroke, Muscle coordination, Visual feedback, Hand
- 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
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 May 2026 (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 following experiment will be conducted with 15 chronic stroke survivors and 15 control subjects. Subjects will perform hand movements in the virtual reality environment using a head-mounted display. Quest's onboard cameras allow real-time tracking of hand motion, estimating joint angles of the finger and the thumb. For each feedback manipulation condition (i.e., movement amplification or reduction), the estimated joint angles will be multiplied by a factor greater than 1 (amplification) or a factor smaller than 1 (reduction). Then the newly-estimated hand posture will be displayed in the VR environment. Subjects will be randomly assigned into two groups (A and B), who will receive the assistance in a different order. Subjects will perform finger extension under three conditions: no sensory modulation, movement visual feedback (VF) amplification, and movement VF reduction (error augmentation), while their movement muscle activation patterns are recorded.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual ROM augmentation followed by visual ROM reduction | Experimental | Device: Visual ROM augmentation, Device: Visual ROM reduction |
| Visual ROM reduction followed by visual ROM augmentation | Experimental | Device: Visual ROM augmentation, Device: Visual ROM reduction |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 20 - 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 |
|---|---|---|
| Visual ROM augmentationFinger joint ROM is amplified. | Device | Visual ROM augmentation followed by visual ROM reduction, Visual ROM reduction followed by visual ROM augmentation |
| Visual ROM reductionVisual feedback of finger joint ROM is reduced. | Device | Visual ROM augmentation followed by visual ROM reduction, Visual ROM reduction followed by visual ROM augmentation |
Primary outcome
Joint range of motion (ROM)
Time frame: Periprocedural
range of motion of individual finger joints under each condition, measured by embedded cameras that digitize individual finger segments
1 secondary outcome
Muscle activation
Time frame: Periprocedural
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 22 May 2026.
- Individual participant dataSharing planned: No. The investigators do not plan to share IPD but the de-identified 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 Visual ROM augmentation and Visual ROM reduction 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 22 May 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?
Joint range of motion (ROM) (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 22 May 2026.