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

NCT07641790 | Recruiting

• 1 other identifier: TUF/EIRB/ 214 /26
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegia; Stroke

Keywords

Vibration; Upper Extremity; Physical Therapy; Subacute Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Functional Independence

  Baseline (Week 0) and Post-intervention (Week 8)

Study Arms (2)

Wearable Vibration + Physiotherapy

EXPERIMENTAL

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

Conventional Physiotherapy Only

ACTIVE COMPARATOR

Participants receive conventional physiotherapy (45 min) without the vibratory device. Sessions occur 3 times/week for 8 weeks.

Device: Wearable Focal Muscle Vibrator

Interventions

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.

Conventional Physiotherapy Only; Wearable Vibration + Physiotherapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

RECRUITING

MeSH Terms

Conditions

Hemiplegia; Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dr. Anbreena Rasool, Doctor of Physical Therapy

CONTACT

+92 345 79368; anbreenarasool.DPT@tuf.edu.pk

Dr Muhammad Ateeb, PhD Public Health

CONTACT

+923357333383; mateeb.oric@tuf.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The physiotherapist administering the treatment and the patients cannot be blinded due to the nature of the device. However, the assessor conducting the Fugl-Meyer and Ashworth scale evaluations will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Rehabilitation Sciences

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 11, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)