Vibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 1

Conditions: Stroke

Treatments: Device: Vibrotactile Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06244719

23-0783

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Vibrotactile Stimulation

Experimental group

Description:

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.

Treatment:

Device: Vibrotactile Stimulation

Control

No Intervention group

Description:

Participants undergo conventional therapy only.