Vibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation

NCT06244719 | Recruiting Phase 1

• 1 other identifier: 23-0783
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).

• Number of participants who completed the therapy

  End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).

• Number of participants who tolerated the vibrotactile stimulation therapy

  End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).

• Change in the modified Ashworth scale

  Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).

Study Arms (2)

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.

Device: Vibrotactile Stimulation

Control

NO INTERVENTION

Participants undergo conventional therapy only.

Interventions

Vibrotactile Stimulation DEVICE

Shirts contain embedded vibration motors that stimulate the impaired upper-extremity at 18 different locations. The gloves stimulates the fingertips.

Vibrotactile Stimulation

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

UCHealth Rehabilitation Unit

Aurora, Colorado, 80045, United States

RECRUITING

Broomfield Hospital

Broomfield, Colorado, 80021, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Mazen Al Borno, PhD

CONTACT

303-315-1408; mazen.alborno@ucdenver.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: February 2, 2024
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

US (2)