An interventional study of Wearable Focal Muscle Vibrator in Hemiplegia and Stroke, sponsored by University of Faisalabad. Recruiting at 1 site in Pakistan. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University of Faisalabad · Not applicable, Interventional, and Treatment
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.
446 studies on the registry are indexed under Hemiplegia; 90 are open to participants now.
This study's planned enrollment of 30 is below the median of 34 across 370 interventional studies indexed under Hemiplegia.
Browse Hemiplegia studies →University of Faisalabad is the lead sponsor of 86 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
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)
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Jun 2026, 4 months after the start.
Of 223 non-industry interventional studies with no phase under Hemiplegia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 4 months is below that.
Counting every sponsor, half of 228 studies reached it within 12 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Faisalabad