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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan
        • Riphah International University
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Device: segmental muscle vibration
Segmental muscle vibration will delivered over the target muscles by means of vibrator with general physical therapy session
Other Names:
  • general physical therapy session
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
Device: segmental muscle vibration
Segmental muscle vibration will delivered over the target muscles by means of vibrator with general physical therapy session
Other Names:
  • general physical therapy session

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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