Vibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Vibrotactile Stimulation for Neurological Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244719
• Other study ID #: 23-0783
• Status: Recruiting
• Phase: Phase 1
• Start date: February 2, 2024
• Est. completion date: February 2, 2025

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Mazen Al Borno, PhD
• Phone: 303-315-1408
• Email: mazen.alborno[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: February 2, 2025
• Est. primary completion date: February 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	UCHealth Rehabilitation Unit	Aurora	Colorado
United States	Broomfield Hospital	Broomfield	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Secondary	Number of participants who completed the therapy	Vibrotactile stimulation therapy feasibility will be assessed by the number of participants who completed the therapy	End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Secondary	Number of participants who tolerated the vibrotactile stimulation therapy	Therapy tolerability will be assessed by responses to questionnaires	End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Secondary	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	Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).