CompletedNot Applicable

Passive Tactile Stimulation for Stroke Rehabilitation

United States35 participantsStarted 2019-05-15

Plain-language summary

Stroke can lead to weakness and spasticity in the arm or hand. The purpose of this study is to optimize the design of gentle vibratory stimulation delivered to the hands of individuals with chronic stroke, and explore the effect on range of movement and spasticity.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 and older. * diagnosis of stroke with upper extremity spasticity or other movement deficits that affect strength and range of movement. * willing to participate in the vibrotactile stimulation sessions for consecutive days and willing to return for follow up visits as needed for the PHASE in progress. * able to provide informed consent. Exclusion Criteria: * Patients with severe contracture that precludes Modified Ashworth Score (MAS) testing.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Modified Ashworth at 12 Weeks

Timeframe: Change from Baseline Modified Ashworth at 12 weeks

Change in Modified Ashworth at 8 Weeks

Timeframe: Change from Baseline Modified Ashworth at 8 weeks

Change in Range of Motion at 8 Weeks

Timeframe: Change from Baseline Range of Motion at 8 weeks

Change in Range of Motion at 12 Weeks

Timeframe: Change from Baseline Range of Motion at 12 weeks

Change in Modified Ashworth During Stimulation (Pattern 1).

Timeframe: 20 minutes after stimulation start

Change in Modified Ashworth During Stimulation (Pattern 2).

Timeframe: 20 minutes after stimulation start

Change in Modified Ashworth During Stimulation (Pattern 3).

Timeframe: 20 minutes after stimulation start

Trial details

NCT IDNCT03814889

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

Results submitted2022-08-26

View on ClinicalTrials.gov More Stroke trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Modified Ashworth at 12 Weeks

Timeframe: Change from Baseline Modified Ashworth at 12 weeks

Change in Modified Ashworth at 8 Weeks

Timeframe: Change from Baseline Modified Ashworth at 8 weeks

Change in Range of Motion at 8 Weeks

Timeframe: Change from Baseline Range of Motion at 8 weeks

Change in Range of Motion at 12 Weeks

Timeframe: Change from Baseline Range of Motion at 12 weeks

Change in Modified Ashworth During Stimulation (Pattern 1).

Timeframe: 20 minutes after stimulation start

Change in Modified Ashworth During Stimulation (Pattern 2).

Timeframe: 20 minutes after stimulation start

Change in Modified Ashworth During Stimulation (Pattern 3).

Timeframe: 20 minutes after stimulation start