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Effect of Segmental Muscle Vibration on Upper Limb Function in Post Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
segmental muscle vibration
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring segmental muscle vibration,spasticity,upper limb function

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Subacute stroke patients

    • Both genders
    • Age: between 50-65 years.
    • Spasticity< 3 on MAS
    • No pain from vibration
    • MOCA more than 24

Exclusion Criteria:

  • • Cardiovascular event (myocardial ischemia or infarction) occurring within 12 months,

    • Injections of antispastic drugs into the upper limb muscles.
    • Patients with aphasia, neglect, or apraxia.
    • Inflammatory osteoarticular diseases

Sites / Locations

  • Muhammad shahid shabbir
  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental Group A

Experimental Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Wolf Motor Functional Test
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.
Modified Ashworth Scale
This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity
Fugl Meyer Assessment
Fugl Meyer Assessment
Manual Muscle Testing
to check muscle strength
• Brunnstrom Stages of Stroke Recovery • Brunnstrom Stages of Stroke Recovery Brunnstrom Stages of Stroke Recovery
to check the stages of improvemnet

Secondary Outcome Measures

Full Information

First Posted
April 28, 2022
Last Updated
September 14, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05356481
Brief Title
Effect of Segmental Muscle Vibration on Upper Limb Function in Post Stroke Patients
Official Title
Comparison Of Segmental Vibration On Flexors and Extensor Muscle Groups On Upper Limb Function In Post-Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
segmental muscle vibration,spasticity,upper limb function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group A
Arm Type
Experimental
Arm Description
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
Arm Title
Experimental Group B
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
segmental muscle vibration
Other Intervention Name(s)
general physical therapy session
Intervention Description
Segmental muscle vibration will delivered over the target muscles by means of vibrator with general physical therapy session
Primary Outcome Measure Information:
Title
Wolf Motor Functional Test
Description
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.
Time Frame
10 to 15 minutes
Title
Modified Ashworth Scale
Description
This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity
Time Frame
4 to 5 minutes
Title
Fugl Meyer Assessment
Description
Fugl Meyer Assessment
Time Frame
10 minutes
Title
Manual Muscle Testing
Description
to check muscle strength
Time Frame
8 to 10 minutes
Title
• Brunnstrom Stages of Stroke Recovery • Brunnstrom Stages of Stroke Recovery Brunnstrom Stages of Stroke Recovery
Description
to check the stages of improvemnet
Time Frame
5 to 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aruba Saeed, PhD*
Organizational Affiliation
Riphah international university.pakistan
Official's Role
Study Chair
Facility Information:
Facility Name
Muhammad shahid shabbir
City
Rawalpindi
State/Province
Punjab
Country
Pakistan
Facility Name
Riphah International University
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Segmental Muscle Vibration on Upper Limb Function in Post Stroke Patients

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