StrokeNCT04569123
Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke
A study testing real stimulation and No stimulation in people with Stroke and Physical Disability, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Physical Disability
- What is being tested?
- real stimulation and No stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- At least 6 months since stroke
- Wolf Motor Function Test (WMFT) total average time >10 seconds
- WFMT hand task average time <120 s
Who cannot join
- Currently undergoing other upper limb therapy
- Change in spasticity medication or upper limb botulinum toxin injection within 3 months prior to or during enrollment
- Severe spasticity that limits participation in task practice therapy (e.g., Modified Ashworth Scale=4-5)
- Comorbidity affecting the upper limb function such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, premorbid peripheral neuropathy, compromised skin integrity of the wrist due to burn or long-term use of blood thinners, or significant new neurological symptoms
- Language barrier or cognitive impairment that precludes following instructions and/or providing consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29403
About this study
The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.
Read the detailed description
Stroke is a leading cause of disability in the U.S., with more than 4 million stroke survivors in the U.S. who suffer from post-stroke hand disability. Post-stroke hand disability impairs stroke survivors' abilities and independence with self-care, hygiene, employment, and leisure, frequently resulting in diminished quality of life. Rehabilitation can often be limited, but research suggests that the effects of therapy is improved by the addition of sensory stimulation.
To fully leverage the potential therapeutic benefits of sensory stimulation, we have developed a new stimulation that is imperceptible random-frequency vibration applied to wrist skin. The objective of this study is to determine if this treatment is superior to task-practice alone in improving hand functional recovery, sensorimotor grip control, and neural communication.
- Conditions
- Stroke, Physical Disability
- Being tested
- real stimulation, No stimulation
- Keywords
- physical stimulation, subliminal stimulation, stroke rehabilitation, physical therapy, occupational therapy, upper extremity, paresis, hand function
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real stimulationDevice
Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
No stimulationDevice
Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.
| Study group | Role | What they receive |
|---|---|---|
| Vibration | Active comparator | The device will deliver imperceptible vibration for the treatment group. Receives: Device: real stimulation |
| No Vibration | Sham comparator | The device will deliver no vibration for the control group. Receives: Device: No stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wolf Motor Function Test (WMFT) Movement Time
The Wolf Motor Function Test (WMFT) is a standardized, timed assessment of upper extremity motor function. This study reports the total average movement time across the WMFT tasks.
Range: 0 seconds to >120 seconds (no fixed upper limit). Interpretation: Lower movement times indicate better motor function. Only this WMFT movement-time variable was analyzed as the pre-specified primary outcome.
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Change in Box and Blocks Test (BBT) Score
The Box and Blocks Test (BBT) measures unilateral gross manual dexterity. Participants move as many blocks as possible from one side of a box to the other in 60 seconds.
Range: 0-150 blocks (typical). Interpretation: Higher scores indicate better manual dexterity.
Measured: Baseline and 6 weeks
Change in Action Research Arm Test (ARAT) Score
The Action Research Arm Test (ARAT) is a standardized measure of upper limb functional ability. It contains 19 items scored 0-3, summed to a total score.
Range: 0-57. Interpretation: Higher scores indicate better upper limb function.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start2 Nov 2020
- Primary completion6 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- 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
- NCT04569123
- Sponsor's protocol ID
- Pro90790
- Other IDs
- 1R01HD094731-01A1
- Status last verified
- Jan 2026
- First submitted
- 23 Sep 2020
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seo NJ, Ramakrishnan V, Woodbury ML, Bonilha L, Finetto C, Schranz C, Scronce G, Coupland K, Blaschke J, Baker A, Howard K, Meinzer C, Velozo CA, Adams RJ. Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. Trials. 2022 Apr 5;23(1):262. doi: 10.1186/s13063-022-06241-9.
PubMed 35382902
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke
- ClinicalTrials.gov ID
- NCT04569123
- Acronym / sponsor ID
- Pro90790
- Conditions
- Stroke, Physical Disability
- Keywords
- physical stimulation, subliminal stimulation, stroke rehabilitation, physical therapy, occupational therapy, upper extremity, paresis, hand function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Posted 9 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.
Detailed description
Stroke is a leading cause of disability in the U.S., with more than 4 million stroke survivors in the U.S. who suffer from post-stroke hand disability. Post-stroke hand disability impairs stroke survivors' abilities and independence with self-care, hygiene, employment, and leisure, frequently resulting in diminished quality of life. Rehabilitation can often be limited, but research suggests that the effects of therapy is improved by the addition of sensory stimulation.
To fully leverage the potential therapeutic benefits of sensory stimulation, we have developed a new stimulation that is imperceptible random-frequency vibration applied to wrist skin. The objective of this study is to determine if this treatment is superior to task-practice alone in improving hand functional recovery, sensorimotor grip control, and neural communication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration | Active comparator | Device: real stimulationThe device will deliver imperceptible vibration for the treatment group. |
| No Vibration | Sham comparator | Device: No stimulationThe device will deliver no vibration for the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- At least 6 months since stroke
- Wolf Motor Function Test (WMFT) total average time >10 seconds
- WFMT hand task average time <120 s
Key exclusion criteria (5 listed)
- Currently undergoing other upper limb therapy
- Change in spasticity medication or upper limb botulinum toxin injection within 3 months prior to or during enrollment
- Severe spasticity that limits participation in task practice therapy (e.g., Modified Ashworth Scale=4-5)
- Comorbidity affecting the upper limb function such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, premorbid peripheral neuropathy, compromised skin integrity of the wrist due to burn or long-term use of blood thinners, or significant new neurological symptoms
- Language barrier or cognitive impairment that precludes following instructions and/or providing consent
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 |
|---|---|---|
| real stimulationParticipants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group. | Device | Vibration |
| No stimulationParticipants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy. | Device | No Vibration |
Primary outcome
Change in Wolf Motor Function Test (WMFT) Movement Time
Time frame: Baseline and 6 weeks
The Wolf Motor Function Test (WMFT) is a standardized, timed assessment of upper extremity motor function. This study reports the total average movement time across the WMFT tasks. Range: 0 seconds to >120 seconds (no fixed upper limit). Interpretation: Lower movement times indicate better motor function. Only this WMFT movement-time variable was analyzed as the pre-specified primary outcome.
2 secondary outcomes
Change in Box and Blocks Test (BBT) Score
Time frame: Baseline and 6 weeks
Change in Action Research Arm Test (ARAT) Score
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35382902Seo NJ, Ramakrishnan V, Woodbury ML, Bonilha L, Finetto C, Schranz C, Scronce G, Coupland K, Blaschke J, Baker A, Howard K, Meinzer C, Velozo CA, Adams RJ. Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. Trials. 2022 Apr 5;23(1):262. doi: 10.1186/s13063-022-06241-9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real stimulation and No stimulation in people with Stroke and Physical Disability, run by Medical University of South Carolina 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 4 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: finished, as of the sponsor's last update on 9 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wolf Motor Function Test (WMFT) Movement Time (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04569123, which also lists 1 linked publication.
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 9 Feb 2026.