Effects of Wearable Vibratory Devices on Arm Function in Subacute Stroke Patients (WEVIB-HEMI)

Effects of Wearable Vibratory Devices for Upper Limb Function Among Subacute Hemiplegic Patients: A Randomized Controlled Trial

Hemiplegia, or paralysis of one side of the body, often results from stroke and severely limits arm function. Standard physiotherapy helps, but recovery is often slow. This study tests if adding a wearable vibratory device to standard therapy improves arm movement better than standard therapy alone. Thirty patients with subacute stroke (3-6 months) will be split into two groups. One group will receive usual physiotherapy, while the other will receive usual physiotherapy plus the vibratory device for 8 weeks. Doctors will measure changes in spasticity (muscle stiffness), motor function, and daily independence before and after treatment.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Hemiplegia
• Intervention / Treatment: Device: Wearable Focal Muscle Vibrator

Detailed Description

This single-center, prospective, randomized, controlled, parallel-group trial aims to investigate the neurophysiological effects of focal muscle vibration (FMV) delivered via a wearable device. The study will enroll 28 participants (14 per arm, accounting for 20% attrition) diagnosed with unilateral hemiplegia in the subacute stage (3 to 6 months post-stroke). Inclusion requires a Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 20 and 50 and a Modified Ashworth Scale (MAS) score indicating mild to moderate spasticity. Exclusion criteria include fixed contractures, severe sensory loss, or other neurological diseases.

Intervention Protocol: Both groups will receive a 45-minute conventional physiotherapy session focusing on range of motion, strengthening, and functional task training, three times per week for 8 weeks. The experimental group (Group A) will additionally wear a portable vibratory device (frequency: 100-120 Hz) on the belly of the affected biceps and forearm extensors for 30 minutes during the therapy session. The device will be applied by a trained physiotherapist. The control group (Group B) receives the same conventional therapy without the vibratory device. Electrical Muscle Stimulation (EMS) will be used as a baseline warm-up for both groups.

Outcomes: The primary outcomes are changes in spasticity (MAS) and motor function (FMA-UE). The secondary outcome is functional independence measured by the Barthel Index. Assessments occur at baseline (Week 0) and post-intervention (Week 8). Data will be analyzed using an intention-to-treat analysis in SPSS v20.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Muhammad Ateeb, PhD Public Health; Phone Number: +923357333383; Email: mateeb.oric@tuf.edu.pk
• Study Contact Backup: Name: Dr. Anbreena Rasool, Doctor of Physical Therapy; Phone Number: +92 345 79368; Email: anbreenarasool.DPT@tuf.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Faisalābad, Punjab Province, Pakistan, 3800
      • Recruiting
      • the University of Faisalabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Unilateral hemiplegia secondary to stroke
• Age between 30 and 60 years
• Subacute stage (3 to 6 months post-stroke)
• Fugl-Meyer Assessment (FMA) score between 20 and 50
• Able to follow simple verbal commands

Exclusion Criteria:

• Previous peripheral nerve injury or surgery affecting the upper limb
• Fixed contractures or bony fractures in the affected limb
• Complete sensory loss of the upper limb
• Co-existing neurological conditions (e.g., Parkinson's, MS, Dementia)
• Unstable cardiovascular conditions

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wearable Vibration + Physiotherapy; Participants receive conventional physiotherapy (45 min) plus a wearable vibratory device applied to the affected upper limb for 30 minutes during the session. Sessions occur 3 times/week for 8 weeks.	Device: Wearable Focal Muscle Vibrator; A portable, battery-operated device worn on the forearm. It delivers high-frequency focal vibration (100-120 Hz) to the muscle belly (biceps/forearm extensors) to reduce spasticity and facilitate motor recruitment.
Active Comparator: Conventional Physiotherapy Only; Participants receive conventional physiotherapy (45 min) without the vibratory device. Sessions occur 3 times/week for 8 weeks.	Device: Wearable Focal Muscle Vibrator; A portable, battery-operated device worn on the forearm. It delivers high-frequency focal vibration (100-120 Hz) to the muscle belly (biceps/forearm extensors) to reduce spasticity and facilitate motor recruitment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Upper Limb Spasticity	Measured by the Modified Ashworth Scale (MAS). Scale ranges from 0 (no increase in tone) to 4 (rigidity). A lower score indicates better outcome.	Baseline (Week 0) and Post-intervention (Week 8)
Change in Upper Limb Motor Function	Measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Total score ranges from 0 to 66. A higher score indicates better motor recovery.	Baseline (Week 0) and Post-intervention (Week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Independence	Measured by the Barthel Index (BI). Total score ranges from 0 (totally dependent) to 100 (completely independent). A higher score indicates better ability to perform activities of daily living.	Baseline (Week 0) and Post-intervention (Week 8)

Collaborators and Investigators

• Sponsor: University of Faisalabad

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: June 6, 2026
• First Submitted That Met QC Criteria: June 6, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Physical Therapy; Vibration; Upper Extremity; Subacute Stroke
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Hemiplegia
• Other Study ID Numbers: TUF/EIRB/ 214 /26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No