Evaluation of Vibration-based Wearable Upper Limb Rehabilitation Device

NCT04698369 | Terminated FDA Device

• 1 other identifier: 9686
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

focal muscle vibration; wearable; mHealth; in-home rehabilitation; stroke; upper extremity

Outcome Measures

Primary Outcomes (7)

• Usability of the WearUL as assessed by the System Usability Scale (SUS)

  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)

  MAUQ is a reliable and valid questionnaire to assess mHealth app usability

  4 weeks

• Changes in grip strength

  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

  Chedoke Arm and Hand Activity Inventory - 7

  Change from Baseline CAHAI-7 at 4 weeks

• Changes in sensorimotor impairment as assessed by FMA-UE

  Fugl-Meyer Assessment of the Upper Extremity

  Change from Baseline FMA-UE at 4 weeks

• Changes in upper extremity performance as assessed by ARAT

  Action Research Arm Test

  Change from Baseline ARAT at 4 weeks

• Changes in self-reported functional upper extremity performance as assessed by MAL

  Motor Activity Log

  Change from Baseline MAL at 4 weeks

Study Arms (4)

low frequency low amplitude

EXPERIMENTAL

The vibration frequency is 60 Hz and amplitude is 0.2 mm

Device: Vibration Massage Therapy

low frequency high amplitude

EXPERIMENTAL

The vibration frequency is 60 Hz and amplitude is 2 mm

Device: Vibration Massage Therapy

high frequency low amplitude

EXPERIMENTAL

The vibration frequency is 120 Hz and amplitude is 0.2 mm

Device: Vibration Massage Therapy

high frequency high amplitude

EXPERIMENTAL

The vibration frequency is 120 Hz and amplitude is 2 mm

Device: Vibration Massage Therapy

Interventions

Vibration Massage Therapy DEVICE

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.

Also known as: WearUL

high frequency high amplitude; high frequency low amplitude; low frequency high amplitude; low frequency low amplitude

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (3)

• Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.

  PMID: 24842220 BACKGROUND

• Paoloni M, Tavernese E, Fini M, Sale P, Franceschini M, Santilli V, Mangone M. Segmental muscle vibration modifies muscle activation during reaching in chronic stroke: A pilot study. NeuroRehabilitation. 2014;35(3):405-14. doi: 10.3233/NRE-141131.

  PMID: 25227540 BACKGROUND

• Celletti C, Sinibaldi E, Pierelli F, Monari G, Camerota F. Focal Muscle Vibration and Progressive Modular Rebalancing with neurokinetic facilitations in post- stroke recovery of upper limb. Clin Ter. 2017 Jan-Feb;168(1):e33-e36. doi: 10.7417/CT.2017.1979.

  PMID: 28240760 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Hongwu Wang, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will not know the vibration intensity they receive. The care provider will be blinded on the vibration intensity as well. The outcome assessor will be blinded on which group the participants are.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized using a computer-generated random table in four blocks of four (four different vibration intensities) to equalize the group numbers across the study period. The four vibration intensities are: 60 Hz 0.2 mm, 60 Hz 2 mm, 120 Hz 0.2 mm, and 120 Hz 2mm.

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: January 6, 2021
• Study Start: August 30, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the completion of the r weeks study
• Access Criteria: Only de-identified data will be shared with permission from the funder and PI per request

Locations

US (1)