- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07629882
Functional Electrical Stimulation Versus Whole-Body Vibration in Post-Stroke Rehabilitation
Comparative Effects of Functional Electrical Stimulation and Whole Body Vibration Training on Lower Limb Motor Control, Balance and Physical Performance in Post-Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Punjab Province
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Gujrat, Punjab Province, Pakistan, 50700
- Hafiz Physiotherapy Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- the patient is between the ages of 35 and 70.
- Both male and female participants will be included.
- Chronic post-stroke patients from 6 months to 1 year.
- Stroke patients who have a neurological impairment.
- Individuals who experienced a single stroke in either the left or right hemisphere of the brain.
- Lower limb motor impairment with Fugl-Meyer Lower Extremity Score ≤ 28.
- Barthel Index Score ≥ 60.
- Berg Balance Scale Score ≥ 21.
Exclusion Criteria:
patients suffering from unstable cardiac condition, severe hypertension, congestive heart failure, aphasia, or cognitive impairments for which exercises are contraindicated.
- Patients with recurrent stroke.
- Patients undergoing other form of lower limb stimulation therapy concurrently.
- Severe orthopedic conditions or joint deformities affecting lower limb.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Functional Electrical Stimulation Group
Participants in this arm will receive transcutaneous Functional Electrical Stimulation for lower limb rehabilitation for 8 weeks.
Stimulation will be applied to selected lower limb muscles including tibialis anterior, quadriceps, hamstrings, and peroneal muscles.
Treatment parameters will progress according to tolerance, including intensity, session duration, and functional movement integration.
Outcomes will be assessed at baseline and after 8 weeks.
|
Functional Electrical Stimulation will be delivered transcutaneously to selected lower limb muscles for 8 weeks.
Stimulation will target tibialis anterior, quadriceps, hamstrings, peroneal muscles, and other lower limb muscles according to patient need and tolerance.
The intervention will use biphasic symmetrical pulsed current with progressive intensity, duration, and functional movement integration.
Treatment will be supervised by a physiotherapist, and outcomes will be assessed at baseline and after 8 weeks.
Other Names:
|
|
Active Comparator: Whole Body Vibration Training Group
Participants in this arm will receive Whole Body Vibration Training using a vibration platform for 8 weeks. Training will include progressive activities such as standing, semi-squat, heel raises, dynamic squatting, side-to-side weight shifting, and one-leg stance. Vibration frequency, duration, and exercise difficulty will be gradually progressed according to tolerance. Outcomes will be assessed at baseline and after 8 weeks. After this, go to Interventions and add Functional Electrical Stimulation and Whole Body Vibration Training, then assign each intervention to its matching arm. |
Whole Body Vibration Training will be delivered using a vibration platform for 8 weeks.
Participants will perform progressive lower limb activities including standing, semi-squat, heel raises, dynamic squatting, side-to-side weight shifting, and one-leg stance exercises.
Frequency, duration, and difficulty will be progressed according to patient tolerance under physiotherapist supervision.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
lower Limb Motor Control
Time Frame: Baseline and 8 weeks post-intervention
|
Assessed using the Fugl-Meyer Assessment for Lower Extremity.
|
Baseline and 8 weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: Baseline and 8 weeks post-intervention
|
Assessed using the Berg Balance Scale.
|
Baseline and 8 weeks post-intervention
|
|
Physical Performance
Time Frame: Baseline and 8 weeks post-intervention
|
Assessed using the Barthel Index Scale.
|
Baseline and 8 weeks post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ambreen Iqbal IQBAL, Riphah International University Role
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOOR NAZISH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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