Recruiting
Phase 1

Vibrotactile Stimulation

Sponsor:

University of Colorado, Denver

Code:

NCT06244719

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

Interventions

Vibrotactile Stimulation

Study Details

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

Study ID

NCT06244719

Start date

Feb 2, 2024

Status verified date

Apr, 2024

Completion date

Feb 2, 2025

Anticipated

Primary completion date

Feb 2, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Control

Participants undergo conventional therapy only.

Interventions

Vibrotactile Stimulation

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

Primary outcome measure

  • Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM) [ Time Frame: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). ]

Central Contacts and Locations

Central contacts

Mazen Al Borno, PhD

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

Locations

UCHealth Rehabilitation Unit

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Mazen Al Borno

650-441-7556mazen.alborno@ucdenver.edu

Broomfield Hospital

Recruiting

Broomfield, Colorado, United States, 80021

Contacts

Mazen Al Borno

650-441-7556mazen.alborno@ucdenver.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 11, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-04-11.