HemiplegiaWEVIB-HEMINCT07641790
Effects of Wearable Vibratory Devices on Arm Function in Subacute Stroke Patients
A study testing Wearable Focal Muscle Vibrator in people with Hemiplegia and Stroke, run by University of Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hemiplegia, Stroke
- What is being tested?
- Wearable Focal Muscle Vibrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
The University of Faisalabad
Faisalābad, Punjab Province, 3800
About this study
Official title: Effects of Wearable Vibratory Devices for Upper Limb Function Among Subacute Hemiplegic Patients: A Randomized Controlled 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.
Read the 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.
- Conditions
- Hemiplegia, Stroke
- Being tested
- Wearable Focal Muscle Vibrator
- Keywords
- Vibration, Upper Extremity, Physical Therapy, Subacute Stroke
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Focal Muscle VibratorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Wearable Focal Muscle Vibrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0) and Post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Feb 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anbreena Rasool, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641790
- Sponsor's protocol ID
- TUF/EIRB/ 214 /26
- Acronym
- WEVIB-HEMI
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wearable Vibratory Devices for Upper Limb Function Among Subacute Hemiplegic Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07641790
- Acronym / sponsor ID
- WEVIB-HEMI / TUF/EIRB/ 214 /26
- Conditions
- Hemiplegia, Stroke
- Keywords
- Vibration, Upper Extremity, Physical Therapy, Subacute Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable Vibration + Physiotherapy | Experimental | Device: Wearable Focal Muscle VibratorParticipants 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. |
| Conventional Physiotherapy Only | Active comparator | Device: Wearable Focal Muscle VibratorParticipants receive conventional physiotherapy (45 min) without the vibratory device. Sessions occur 3 times/week for 8 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Focal Muscle VibratorA 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. | Device | Conventional Physiotherapy Only, Wearable Vibration + Physiotherapy |
Primary outcome
Change in Upper Limb Spasticity
Time frame: 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
Time frame: 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.
1 secondary outcome
Change in Functional Independence
Time frame: Baseline (Week 0) and Post-intervention (Week 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Focal Muscle Vibrator in people with Hemiplegia and Stroke, run by University of Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Anbreena Rasool, Doctor of Physical Therapy (+92 345 79368, anbreenarasool.DPT@tuf.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Limb Spasticity (time frame: Baseline (Week 0) and Post-intervention (Week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.