- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05356481
Effect of Segmental Muscle Vibration on Upper Limb Function in Post Stroke Patients
September 14, 2023 updated by: Riphah International University
Comparison Of Segmental Vibration On Flexors and Extensor Muscle Groups On Upper Limb Function In Post-Stroke Patients
The aim of this study is to observe and to compare effects of segmental vibration on flexors versus extensor muscle groups on upper limb function in post-stroke patients.
This study will be helpful in finding out that either low frequency segmental vibration on flexors muscle group is better in improving upper limb function or low frequency segmental vibration on extensor muscle group is more beneficent in improving upper limb function.
Study Overview
Detailed Description
Stroke is the leading cause of long-term disability and is often associated with persistent involvement of upper limbs.Several disturbances are the manifestation of UL impairments after stroke (i.e., muscle weakness, changes in muscle tone, joint disturbances, impaired motor control) .
Muscular weakness and spasticity are most commonly observed in post stroke patients.
There are many strategies are developed to improve functional status and to reduce spasticity pattern in post stroke patients.
Among the different approaches to improve motor functions in post stroke patients, vibration therapy gives strong stimulatory effects in post paretic limb.
Segmental muscle vibration (SMV) is a fairly new technique that has been used to improve motor function and inhibit spasticity in the hemiplegic upper extremity of patients following a stroke.
In SMV, a vibratory stimulus is applied to a specific muscle tendon using a mechanical device unit.The aim of this study is to observe and to compare effects of segmental vibration on flexors versus extensor muscle groups on upper limb function in post-stroke patients.
This study will be helpful in finding out that either low frequency segmental vibration on flexors muscle group is better in improving upper limb function or low frequency segmental vibration on extensor muscle group is more beneficent in improving upper limb function.
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan
- Riphah International University
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Rawalpindi, Punjab, Pakistan
- Muhammad shahid shabbir
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both genders
- Age: between 50-65 years.
- Spasticity 1-3 on MAS
- 3-6 months post stroke patients
Exclusion Criteria:
- Cardiovascular event (myocardial ischemia or infarction) occurring within 12 months,
- Use of any antispastic drug
- Pain from vibration
- Inflammatory osteoarticular diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Experimental Group A
will recieve (low frequency segmental muscle vibration of 41 Hz over flexors muscles of upper limb Pectoralis minor, Biceps brachii, Flexor carpi muscle + general physical therapy session ) The transducer applied perpendicular to the muscle near its distal tendon insertion.The application consisted of 3 vibration sessions each with duration of 5 minutes for each muscle with 1 minute interval separated these sessions during the interval muscle vibration will interrupted and the subject will request to relax the muscle
|
Segmental muscle vibration will delivered over the target muscles by means of vibrator with general physical therapy session
Other Names:
|
|
Experimental: Experimental Group B
group receive (low frequency segmental muscle vibration of 41 Hz over extensors muscles of upper limb Triceps brachii, Extensor carpi radialis longus & brevis + general physical therapy session ) The transducer applied perpendicular to the muscle near its distal tendon insertion The application consisted of 3 vibration sessions each with duration of 5 minutes for each muscle with 1 minute interval separated these sessions during the interval muscle vibration will interrupted and the subject will request to relax the muscle
|
Segmental muscle vibration will delivered over the target muscles by means of vibrator with general physical therapy session
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wolf Motor Functional Test
Time Frame: 10 to 15 minutes
|
WMFT is valid and reliable on assessing upper extremities motor function of stroke patients.
The WFMT is a tool with high interrater reliability, internal consistency, test-retest reliability and adequate stability.
|
10 to 15 minutes
|
|
Modified Ashworth Scale
Time Frame: 4 to 5 minutes
|
This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity
|
4 to 5 minutes
|
|
Fugl Meyer Assessment
Time Frame: 10 minutes
|
Fugl Meyer Assessment
|
10 minutes
|
|
Manual Muscle Testing
Time Frame: 8 to 10 minutes
|
to check muscle strength
|
8 to 10 minutes
|
|
• Brunnstrom Stages of Stroke Recovery • Brunnstrom Stages of Stroke Recovery Brunnstrom Stages of Stroke Recovery
Time Frame: 5 to 10 minutes
|
to check the stages of improvemnet
|
5 to 10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Aruba Saeed, PhD*, Riphah international university.pakistan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2023
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
July 30, 2023
Study Registration Dates
First Submitted
April 28, 2022
First Submitted That Met QC Criteria
April 28, 2022
First Posted (Actual)
May 2, 2022
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
September 14, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01390 Shahid Shabbir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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