StrokePhase 1NCT06244719
Vibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation
A Phase 1 study testing Vibrotactile Stimulation in people with Stroke, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The goal of this clinical trial is to investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are: Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function? Participants will wear vibrotactile… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Vibrotactile Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Feb 2024to 2 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients at rehabilitation units
- Unilateral left or right sided ischemic stroke within the previous 2 weeks
- Have Upper-Extremity Fugl-Meyer scores between 6 and 58
- Have at least 20 degrees of active shoulder elevation and elbow flexion
- Expected to stay 1-3 weeks in the rehabilitation unit
Who cannot join
- Under anti-spasticity therapy
- Patients that are dependent on pacemakers
- Patients that have defibrillators
- Have lymphedema or AV fistula for dialysis on an arm
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
UCHealth Rehabilitation Unit
Aurora, Colorado, 80045
Mazen Al Borno, 650-441-7556, mazen.alborno@ucdenver.edu
- Recruiting
Broomfield Hospital
Broomfield, Colorado, 80021
Mazen Al Borno, 650-441-7556, mazen.alborno@ucdenver.edu
About this study
Official title: Vibrotactile Stimulation for Neurological Disorders
The goal of this clinical trial is to investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are:
Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function?
Participants will wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy. Researchers will compare the treatment group (vibrotactile stimulation wearables) with a control group (conventional therapy only) to see the effects of the vibrotactile stimulation.
- Conditions
- Stroke
- Being tested
- Vibrotactile Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile StimulationDevice
Shirts contain embedded vibration motors that stimulate the impaired upper-extremity at 18 different locations. The gloves stimulates the fingertips.
| Study group | Role | What they receive |
|---|---|---|
| Vibrotactile Stimulation | Experimental | Participants wear vibrotactile stimulation shirts and gloves for 5 hours per day, 7 days per week, during their stay at the rehabilitation unit, which is expected to be between 2-3 weeks. Participants wear the devices after conventional therapy is done for the day. Receives: Device: Vibrotactile Stimulation |
| Control | No intervention | Participants undergo conventional therapy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions. Scores are between 0 and 66.
Measured: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Secondary outcomes (4)
Number of participants with at least one adverse event
Adverse event will only include those that are determined to be related to the vibrotactile stimulation
Measured: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Number of participants who completed the therapy
Vibrotactile stimulation therapy feasibility will be assessed by the number of participants who completed the therapy
Measured: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Number of participants who tolerated the vibrotactile stimulation therapy
Therapy tolerability will be assessed by responses to questionnaires
Measured: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Change in the modified Ashworth scale
The modified Ashworth scale is used to assess spasticity and tests the resistance to passive movement about a joint with varying degree of velocity. The modified Ashworth scale assigns a grade of spasticity from a 0-4 ordinal scale
Measured: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start2 Feb 2024
- Primary completion2 Feb 2025 (estimated)
- Study completion2 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 University of Colorado, DenverThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244719
- Sponsor's protocol ID
- 23-0783
- Status last verified
- Apr 2024
- First submitted
- 29 Jan 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ayyad W, Kim Y, Odom N, Al Borno M. Wearable vibrotactile stimulation shirts and gloves for upper extremity stroke rehabilitation: A pilot randomized controlled trial. medRxiv [Preprint]. 2026 Aug 5:2026.07.26.26358522. doi: 10.64898/2026.07.26.26358522.
PubMed 42619984
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Stimulation for Neurological Disorders
- ClinicalTrials.gov ID
- NCT06244719
- Acronym / sponsor ID
- 23-0783
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 2 Feb 2025 (estimated)
- Study completion
- 2 Feb 2025 (estimated)
- First posted
- 6 Feb 2024 (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 goal of this clinical trial is to investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are:
Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function?
Participants will wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy. Researchers will compare the treatment group (vibrotactile stimulation wearables) with a control group (conventional therapy only) to see the effects of the vibrotactile stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibrotactile Stimulation | Experimental | Device: Vibrotactile StimulationParticipants wear vibrotactile stimulation shirts and gloves for 5 hours per day, 7 days per week, during their stay at the rehabilitation unit, which is expected to be between 2-3 weeks. Participants wear the devices after conventional therapy is done for the day. |
| Control | No intervention | –Participants undergo conventional therapy only. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inpatients at rehabilitation units
- Unilateral left or right sided ischemic stroke within the previous 2 weeks
- Have Upper-Extremity Fugl-Meyer scores between 6 and 58
- Have at least 20 degrees of active shoulder elevation and elbow flexion
- Expected to stay 1-3 weeks in the rehabilitation unit
Key exclusion criteria (4 listed)
- Under anti-spasticity therapy
- Patients that are dependent on pacemakers
- Patients that have defibrillators
- Have lymphedema or AV fistula for dialysis on an arm
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 |
|---|---|---|
| Vibrotactile StimulationShirts contain embedded vibration motors that stimulate the impaired upper-extremity at 18 different locations. The gloves stimulates the fingertips. | Device | Vibrotactile Stimulation |
Primary outcome
Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time frame: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions. Scores are between 0 and 66.
4 secondary outcomes
Number of participants with at least one adverse event
Time frame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Number of participants who completed the therapy
Time frame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Number of participants who tolerated the vibrotactile stimulation therapy
Time frame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Change in the modified Ashworth scale
Time frame: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 42619984Ayyad W, Kim Y, Odom N, Al Borno M. Wearable vibrotactile stimulation shirts and gloves for upper extremity stroke rehabilitation: A pilot randomized controlled trial. medRxiv [Preprint]. 2026 Aug 5:2026.07.26.26358522. doi: 10.64898/2026.07.26.26358522.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vibrotactile Stimulation in people with Stroke, run by University of Colorado, Denver at 2 sites 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mazen Al Borno, PhD (303-315-1408, mazen.alborno@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM) (time frame: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).). 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 NCT06244719, 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 11 Apr 2024.