Vibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation

Phase 1

Recruiting

• Conditions: Stroke
• Interventions: Device: Vibrotactile Stimulation

• Registration Number: NCT06244719
• Lead Sponsor: University of Colorado, Denver

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study Start: 2024-02-02
• Study First Posted: 2024-02-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-02-02
• Study Completion: 2025-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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

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Exclusion Criteria

• Under anti-spasticity therapy
• Patients that are dependent on pacemakers
• Patients that have defibrillators
• Have lymphedema or AV fistula for dialysis on an arm

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibrotactile Stimulation	Vibrotactile Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants who tolerated the vibrotactile stimulation therapy	End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).	Therapy tolerability will be assessed by responses to questionnaires
Change in the modified Ashworth scale	Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).	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
Number of participants with at least one adverse event	End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).	Adverse event will only include those that are determined to be related to the vibrotactile stimulation
Number of participants who completed the therapy	End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).	Vibrotactile stimulation therapy feasibility will be assessed by the number of participants who completed the therapy

Trial Locations

Locations (2)

UCHealth Rehabilitation Unit; 🇺🇸 Aurora, Colorado, United States

Broomfield Hospital; 🇺🇸 Broomfield, Colorado, United States