Effects of Wearable Vibratory Devices on Arm Function in Subacute Stroke Patients (WEVIB-HEMI)
Effects of Wearable Vibratory Devices for Upper Limb Function Among Subacute Hemiplegic Patients: A Randomized Controlled Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Dr Muhammad Ateeb, PhD Public Health
- Telefoonnummer: +923357333383
- E-mail: mateeb.oric@tuf.edu.pk
Studie Contact Back-up
- Naam: Dr. Anbreena Rasool, Doctor of Physical Therapy
- Telefoonnummer: +92 345 79368
- E-mail: anbreenarasool.DPT@tuf.edu.pk
Studie Locaties
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Punjab Province
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Faisalābad, Punjab Province, Pakistan, 3800
- Werving
- The University of Faisalabad
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Wearable Vibration + Physiotherapy
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.
|
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.
|
|
Actieve vergelijker: Conventional Physiotherapy Only
Participants receive conventional physiotherapy (45 min) without the vibratory device.
Sessions occur 3 times/week for 8 weeks.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Upper Limb Spasticity
Tijdsspanne: Baseline (Week 0) and Post-intervention (Week 8)
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Measured by the Modified Ashworth Scale (MAS).
Scale ranges from 0 (no increase in tone) to 4 (rigidity).
A lower score indicates better outcome.
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Baseline (Week 0) and Post-intervention (Week 8)
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Change in Upper Limb Motor Function
Tijdsspanne: Baseline (Week 0) and Post-intervention (Week 8)
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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.
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Baseline (Week 0) and Post-intervention (Week 8)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Functional Independence
Tijdsspanne: Baseline (Week 0) and Post-intervention (Week 8)
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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.
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Baseline (Week 0) and Post-intervention (Week 8)
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TUF/EIRB/ 214 /26
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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