StrokeNCT05356481
Effect of Segmental Muscle Vibration on Upper Limb Function in Post Stroke Patients
A study testing segmental muscle vibration in people with Stroke, run by Riphah International University at 2 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- segmental muscle vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Jan 2023to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders
- Age: between 50-65 years.
- Spasticity 1-3 on MAS
- 3-6 months post stroke patients
Who cannot join
- Cardiovascular event (myocardial ischemia or infarction) occurring within 12 months,
- Use of any antispastic drug
- Pain from vibration
- Inflammatory osteoarticular diseases
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Muhammad shahid shabbir
Rawalpindi, Punjab Province
Riphah International University
Rawalpindi, Punjab Province
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- segmental muscle vibration
- Keywords
- segmental muscle vibration,spasticity,upper limb function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
segmental muscle vibrationDevice
Also called general physical therapy session
Segmental muscle vibration will delivered over the target muscles by means of vibrator with general physical therapy session
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A | Experimental | 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 Receives: Device: segmental muscle vibration |
| Experimental Group B | Experimental | 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 Receives: Device: segmental muscle vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 to 15 minutes
Modified Ashworth Scale
This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity
Measured: 4 to 5 minutes
Fugl Meyer Assessment
Fugl Meyer Assessment
Measured: 10 minutes
Manual Muscle Testing
to check muscle strength
Measured: 8 to 10 minutes
• Brunnstrom Stages of Stroke Recovery • Brunnstrom Stages of Stroke Recovery Brunnstrom Stages of Stroke Recovery
to check the stages of improvemnet
Measured: 5 to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start15 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD*, Study chair, Riphah international university.pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356481
- Sponsor's protocol ID
- REC/01390 Shahid Shabbir
- Status last verified
- Sep 2023
- First submitted
- 28 Apr 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shabbir MS, Saeed A, Tariq S, Shabbir N, Nasir R, Riaz H. Effects of segmental muscle vibration on flexor and extensor groups of the upper limb in enhancing functional recovery after stroke: A randomized trial. J Bodyw Mov Ther. 2025 Dec;45:1-7. doi: 10.1016/j.jbmt.2025.07.019. Epub 2025 Jul 25.
PubMed 41316550
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Segmental Vibration On Flexors and Extensor Muscle Groups On Upper Limb Function In Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT05356481
- Acronym / sponsor ID
- REC/01390 Shahid Shabbir
- Conditions
- Stroke
- Keywords
- segmental muscle vibration,spasticity,upper limb function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A | Experimental | Device: segmental muscle vibrationwill 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 |
| Experimental Group B | Experimental | Device: segmental muscle vibrationgroup 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 |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders
- Age: between 50-65 years.
- Spasticity 1-3 on MAS
- 3-6 months post stroke patients
Key exclusion criteria (4 listed)
- Cardiovascular event (myocardial ischemia or infarction) occurring within 12 months,
- Use of any antispastic drug
- Pain from vibration
- Inflammatory osteoarticular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| segmental muscle vibrationAlso: general physical therapy sessionSegmental muscle vibration will delivered over the target muscles by means of vibrator with general physical therapy session | Device | Experimental Group A, Experimental Group B |
Primary outcome
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.
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
Fugl Meyer Assessment
Time frame: 10 minutes
Fugl Meyer Assessment
Manual Muscle Testing
Time frame: 8 to 10 minutes
to check muscle strength
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 41316550Shabbir MS, Saeed A, Tariq S, Shabbir N, Nasir R, Riaz H. Effects of segmental muscle vibration on flexor and extensor groups of the upper limb in enhancing functional recovery after stroke: A randomized trial. J Bodyw Mov Ther. 2025 Dec;45:1-7. doi: 10.1016/j.jbmt.2025.07.019. Epub 2025 Jul 25.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
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Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aruba Saeed, PhD* study chair
Riphah international university.pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing segmental muscle vibration in people with Stroke, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Functional Test (time frame: 10 to 15 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05356481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.