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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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.
The University of Faisalabad
Faisalābad, Punjab Province, Pakistan
RECRUITINGChange 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.
Time frame: 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.
Time frame: Baseline (Week 0) and Post-intervention (Week 8)
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.
Time frame: Baseline (Week 0) and Post-intervention (Week 8)
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