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NCT Number: NCT07641790

Effects of Wearable Vibratory Devices on Arm Function in Subacute Stroke Patients

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.

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Key information

Conditions

Hemiplegia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wearable Focal Muscle Vibrator

Device

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.

Primary outcomes

  1. Change in Upper Limb Spasticity

    Time frame: Baseline (Week 0) and Post-intervention (Week 8)

    Measured by the Modified Ashworth Scale (MAS). Scale ranges from 0 (no increase in tone) to 4 (rigidity). A lower score indicates better outcome.

  2. Change in Upper Limb Motor Function

    Time frame: Baseline (Week 0) and Post-intervention (Week 8)

    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.

Secondary outcomes

  1. Change in Functional Independence

    Time frame: Baseline (Week 0) and Post-intervention (Week 8)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Muhammad Ateeb, PhD Public Health

CONTACT

[email protected]

+923357333383

Dr. Anbreena Rasool, Doctor of Physical Therapy

CONTACT

[email protected]

+92 345 79368

Sponsors and collaborators

Lead sponsor

University of Faisalabad

Other

Registry information

Official study title

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

Acronym: WEVIB-HEMI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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