Hemiplegia, Stroke
Conditions
Keywords
Vibration, Upper Extremity, Physical Therapy, Subacute Stroke
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.
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.
Interventions
DEVICEWearable 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.
Sponsors
University of Faisalabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Limb Spasticity | 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. |
| Change in Upper Limb Motor Function | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Independence | 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. |
Countries
Pakistan
Contacts
CONTACTDr. Anbreena Rasool, Doctor of Physical Therapy
CONTACTDr Muhammad Ateeb, PhD Public Health
Outcome results
None listed