Evaluation of Vibration-based Wearable Upper Limb Rehabilitation Device

March 31, 2026 updated by: University of Oklahoma

Development and Evaluation of Vibration-based Wearable Upper Limb Rehabilitation Device

The investigators will perform a pilot 4-week at home study with 48 individuals with stroke and 10 therapists working with stroke patients to examine the feasibility and effect of a wearable focal muscle vibration device on upper limb strength and function.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Stroke often leads to significant impairment of upper limb function and is associated with decreased quality of life. Patients have difficulty moving out of the upper extremity flexion synergies that often dominate attempts to function after stroke. Change in muscle activation is the key underlying factor. Despite study results from several interventions for muscle activation and motor coordination, wide-scale adoption remains largely elusive due to the lack of sustainability of those interventions. The main reasons for the unsustainability are under-doses of the interventions and low patient compliance and participation. Recent studies among individuals without disabilities as well as those with strokes have shown that with focal vibration, there is greater potential to increase and coordinate muscle recruitment and build muscle strength and endurance. This form of treatment could widely benefit stroke patients and therapists who are in need of sustainable intervention that is effective and efficient to building muscle work capacity for function. Thus, the aims of this study are to evaluate the usability and feasibility of a novel vibration-based wearable device for upper limb rehabilitation in stroke patients. Forty-eight stroke patients and 10 therapists working with those stroke patients will be recruited to evaluate the usability of the device. All stroke patients will participate in a 4-week in-home vibration treatment to evaluate the feasibility of the device. Patients will be randomized into four groups receiving vibrations with different frequency (60 Hz or 120 Hz) and amplitude (0.2mm or 2mm). All groups will follow a prescribed dose of vibration based on the therapists' recommendations. Strength and functional outcomes will be measured before and after the 4-week in-home intervention. The investigators hypothesize that all groups will show an increase in grip strength and upper limb function at the end of study compared to baseline and that the increases in outcomes will be different in different groups. The investigators also expect all participants will tolerate the wearable device without adverse side effects and report high levels of satisfaction with the device. This pilot study may help to develop a novel sustainable wearable system providing vibration-based muscle activation for upper limb function rehabilitation. It may provide patients opportunity to apply the prescribed vibratory stimuli in-home and/or at community settings. It may also allow therapists to monitor treatment usage and patient performance and to adjust the treatment doses based on progression.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke with Chedoke McMaster's Stroke Assessment (CMSA) level four or above;
  • over 18 years of age;
  • have been using a smartphone more than one year;
  • live within 40 miles from the University of Oklahoma Health Sciences Center (OUHSC)

Exclusion Criteria:

  • a history of fractures or dislocations in the shoulder, elbow, or wrist from which the participant has not fully recovered,
  • severe impairment of verbal communication ability (for example, severe aphasia),
  • inability to consent (for example, dementia),
  • simultaneous participation in another treatment study targeting stroke recovery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low frequency low amplitude
The vibration frequency is 60 Hz and amplitude is 0.2 mm
Device: Vibration Massage Therapy
WearUL is a patent pending wearable rehabilitation technology that targets localized vibration massage therapy directly onto the body. The frequency and amplitude combinations to be delivered by WearUL are safe and effective in clinical and research settings based on previous studies on focal vibration.
Other Names:
  • WearUL
Experimental: low frequency high amplitude
The vibration frequency is 60 Hz and amplitude is 2 mm
Device: Vibration Massage Therapy
WearUL is a patent pending wearable rehabilitation technology that targets localized vibration massage therapy directly onto the body. The frequency and amplitude combinations to be delivered by WearUL are safe and effective in clinical and research settings based on previous studies on focal vibration.
Other Names:
  • WearUL
Experimental: high frequency low amplitude
The vibration frequency is 120 Hz and amplitude is 0.2 mm
Device: Vibration Massage Therapy
WearUL is a patent pending wearable rehabilitation technology that targets localized vibration massage therapy directly onto the body. The frequency and amplitude combinations to be delivered by WearUL are safe and effective in clinical and research settings based on previous studies on focal vibration.
Other Names:
  • WearUL
Experimental: high frequency high amplitude
The vibration frequency is 120 Hz and amplitude is 2 mm
Device: Vibration Massage Therapy
WearUL is a patent pending wearable rehabilitation technology that targets localized vibration massage therapy directly onto the body. The frequency and amplitude combinations to be delivered by WearUL are safe and effective in clinical and research settings based on previous studies on focal vibration.
Other Names:
  • WearUL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the WearUL as assessed by the System Usability Scale (SUS)
Time Frame: 4 weeks
SUS is a reliable tool for measuring the usability of a device or system
4 weeks
Usability of the WearUL app as assessed by the mHealth App Usability Questionnaire (MAUQ)
Time Frame: 4 weeks
MAUQ is a reliable and valid questionnaire to assess mHealth app usability
4 weeks
Changes in grip strength
Time Frame: Change from Baseline Grip Strength at 4 weeks
the affected side grip strength measured by a dynamometer
Change from Baseline Grip Strength at 4 weeks
Changes in arm and hand function as assessed by CAHAI-7
Time Frame: Change from Baseline CAHAI-7 at 4 weeks
Chedoke Arm and Hand Activity Inventory - 7
Change from Baseline CAHAI-7 at 4 weeks
Changes in sensorimotor impairment as assessed by FMA-UE
Time Frame: Change from Baseline FMA-UE at 4 weeks
Fugl-Meyer Assessment of the Upper Extremity
Change from Baseline FMA-UE at 4 weeks
Changes in upper extremity performance as assessed by ARAT
Time Frame: Change from Baseline ARAT at 4 weeks
Action Research Arm Test
Change from Baseline ARAT at 4 weeks
Changes in self-reported functional upper extremity performance as assessed by MAL
Time Frame: Change from Baseline MAL at 4 weeks
Motor Activity Log
Change from Baseline MAL at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Hongwu Wang, PhD, University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2021

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9686P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified data might be shared with permission from the funder and PI per request.

IPD Sharing Time Frame

After the completion of the r weeks study

IPD Sharing Access Criteria

Only de-identified data will be shared with permission from the funder and PI per request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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