Health TrialsbyHealthPanel

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

ConditionsHemiplegiaStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorUniversity of Faisalabad

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Wearable Vibration + PhysiotherapyExperimental treatment 1 intervention
Group B: Conventional Physiotherapy OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)

Secondary outcomes

1

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)

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

The University of FaisalabadRecruiting3800, Faisalābad, Punjab ProvincePakistanPakistan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Faisalabad

Lead sponsor

Source ClinicalTrials.gov
Apply now