StrokeNCT06567223
Effectiveness of WBV Versus RAS on Spasticity, Balance, and Lower Limb Motor Function on Hemiplegic Stroke Patients
A study testing Vibration Therapy and Rhythmic auditory stimulation therapy. in people with Stroke, run by Superior University at 2 sites in Pakistan.
Trial summary
This study investigates the effectiveness of whole-body vibration (WBV) versus rhythmic auditory stimulation (RAS) on spasticity, balance, and lower limb motor function in hemiplegic stroke patients. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Vibration Therapy and Rhythmic auditory stimulation therapy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Oct 2023to 30 Sep 2024
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant with Age from 40 to 60 years
- Both males and females
- Diagnosed CVA patients
- Chronic stage (after 6 months of onset
- Individuals with BBS score ≥ 20 ≤ 40
- FMI score up to 3(moderate assistance)
- Able to understand command
- Mini-Mental State Examination (MMSE) score of over 20
Who cannot join
- Systematic Disorder e.g. Rheumatoid arthritis
- Unstable Angina
- Coexisting physical impairments e.g. limb amputation
- Any previous history of neurological disease other than stroke e.g. Parkinson's
- Any previous history of fractures
- Hearing or perception deficits
- Individuals unable to adhere to the study protocol or attend scheduled follow-up visits.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Lahore, Punjab Province
Sehat Medical Complex, Hanjerwal
Lahore, Punjab Province
About this study
Official title: Effectiveness of Whole-Body Vibration Versus Rhythmic Auditory Stimulation on Spasticity, Balance, and Lower Limb Motor Function on Hemiplegic Stroke Patients
This study investigates the effectiveness of whole-body vibration (WBV) versus rhythmic auditory stimulation (RAS) on spasticity, balance, and lower limb motor function in hemiplegic stroke patients. The objective was to compare the two interventions to determine which provides greater benefits in stroke rehabilitation. Hemiplegic stroke patients were randomly assigned to either the WBV group, receiving whole-body vibration therapy, or the RAS group, undergoing rhythmic auditory stimulation sessions.
Read the detailed description
The study measured spasticity using the Modified Ashworth Scale (MAS), balance with the Berg Balance Scale (BBS), and lower limb motor function through the Fugl-Meyer Assessment (FMA). Results indicated that both WBV and RAS significantly improved spasticity, balance, and lower limb motor function.
- Conditions
- Stroke
- Being tested
- Vibration Therapy, Rhythmic auditory stimulation therapy.
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration TherapyProcedure or surgery
will receive the whole body vibration therapy. Patient will be ask to stand on the vibration plate in semi flexed knee position will 3 minute time of rest and therapy. It will be given for four weeks three days per week. Acceleration will be 18.0 meter per second square and frequency will be from 30 to 40 Hz. Intensity of the therapy will increase throughout all the sessions
Rhythmic auditory stimulation therapy.Combination product
will receive rhythmic auditory stimulation therapy. Rhythmic auditory stimulation will be given for 90 minutes along with 30 minutes of conventional physiotherapy. It will consist of 15 minutes of general body warming metronome rhythm which proceed towards RAS music based exercise of 60 minutes. This period also ends up with 15 minutes of relaxation exercise. Relaxing Music was provided through headphones having voice cancellation property for 15 min. The total session will be given three days per week for four weeks. Exercises such as lateral walking military march, anterior walking, one toe and one heel walking along with posterior walking through progression with the speed of the rhythm is done
| Study group | Role | What they receive |
|---|---|---|
| Vibration Therapy | Experimental | Not described Receives: Procedure: Vibration Therapy |
| Rhythmic auditory stimulation therapy. | Active comparator | Not described Receives: Combination Product: Rhythmic auditory stimulation therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
Modified Ashworth Scale is a scale which is used to assess spasticity in a patient. It is range from 0 to 4 where 0 shows no muscle tone with no range to 4 which shows maximum muscle tone with full range..
Measured: 12 Months
Berg balance scale
Balance was measured by using BBS which was created in 1989 to measure balance in the older people. The Berg balance scale 27 assesses practical balance performance on 14 things normal to everyday life. The scale comprises of 14 items, scored from 0 to 4, which are added to make an all-out score somewhere in the range of 0 and 56; a higher score shows better balance
Measured: 12 months
Fugl-Meyer Assessment (FMA)
Fugl-Meyer Assessment (FMA) for Lower Limb. In order to assess the lower extremity motor control fugal Meyer assessment test which is a strokes specific test was used to assess the motor function balance and sensation in stroke patients. Its scoring is through 3 point ordinal scale where 2 is performed fully and 1 is performed partially. It has a maximum score of 34
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Oct 2023
- Primary completion1 Jun 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567223
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/737
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Whole-Body Vibration Versus Rhythmic Auditory Stimulation on Spasticity, Balance, and Lower Limb Motor Function on Hemiplegic Stroke Patients
- ClinicalTrials.gov ID
- NCT06567223
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/737
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 22 Aug 2024 (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.
This study investigates the effectiveness of whole-body vibration (WBV) versus rhythmic auditory stimulation (RAS) on spasticity, balance, and lower limb motor function in hemiplegic stroke patients. The objective was to compare the two interventions to determine which provides greater benefits in stroke rehabilitation. Hemiplegic stroke patients were randomly assigned to either the WBV group, receiving whole-body vibration therapy, or the RAS group, undergoing rhythmic auditory stimulation sessions.
Detailed description
The study measured spasticity using the Modified Ashworth Scale (MAS), balance with the Berg Balance Scale (BBS), and lower limb motor function through the Fugl-Meyer Assessment (FMA). Results indicated that both WBV and RAS significantly improved spasticity, balance, and lower limb motor function.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration Therapy | Experimental | Procedure: Vibration Therapy |
| Rhythmic auditory stimulation therapy. | Active comparator | Combination Product: Rhythmic auditory stimulation therapy. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participant with Age from 40 to 60 years
- Both males and females
- Diagnosed CVA patients
- Chronic stage (after 6 months of onset
- Individuals with BBS score ≥ 20 ≤ 40
Key exclusion criteria (7 listed)
- Systematic Disorder e.g. Rheumatoid arthritis
- Unstable Angina
- Coexisting physical impairments e.g. limb amputation
- Any previous history of neurological disease other than stroke e.g. Parkinson's
- Any previous history of fractures
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 |
|---|---|---|
| Vibration Therapywill receive the whole body vibration therapy. Patient will be ask to stand on the vibration plate in semi flexed knee position will 3 minute time of rest and therapy. It will be given for four weeks three days per week. Acceleration will be 18.0 meter per second square and frequency will be from 30 to 40 Hz. Intensity of the therapy will increase throughout all the sessions | Procedure or surgery | Vibration Therapy |
| Rhythmic auditory stimulation therapy.will receive rhythmic auditory stimulation therapy. Rhythmic auditory stimulation will be given for 90 minutes along with 30 minutes of conventional physiotherapy. It will consist of 15 minutes of general body warming metronome rhythm which proceed towards RAS music based exercise of 60 minutes. This period also ends up with 15 minutes of relaxation exercise. Relaxing Music was provided through headphones having voice cancellation property for 15 min. The total session will be given three days per week for four weeks. Exercises such as lateral walking military march, anterior walking, one toe and one heel walking along with posterior walking through progression with the speed of the rhythm is done | Combination product | Rhythmic auditory stimulation therapy. |
Primary outcome
Modified Ashworth Scale
Time frame: 12 Months
Modified Ashworth Scale is a scale which is used to assess spasticity in a patient. It is range from 0 to 4 where 0 shows no muscle tone with no range to 4 which shows maximum muscle tone with full range..
Berg balance scale
Time frame: 12 months
Balance was measured by using BBS which was created in 1989 to measure balance in the older people. The Berg balance scale 27 assesses practical balance performance on 14 things normal to everyday life. The scale comprises of 14 items, scored from 0 to 4, which are added to make an all-out score somewhere in the range of 0 and 56; a higher score shows better balance
Fugl-Meyer Assessment (FMA)
Time frame: 12 months
Fugl-Meyer Assessment (FMA) for Lower Limb. In order to assess the lower extremity motor control fugal Meyer assessment test which is a strokes specific test was used to assess the motor function balance and sensation in stroke patients. Its scoring is through 3 point ordinal scale where 2 is performed fully and 1 is performed partially. It has a maximum score of 34
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration Therapy and Rhythmic auditory stimulation therapy. in people with Stroke, run by Superior 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. 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?
Results are not available in the source record.
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?
Modified Ashworth Scale (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2024.