Spastic Cerebral PalsyNCT06407921
Whole Body Vibration and BOSU Ball in Spastic Cerebral Palsy
A study testing Whole Body Vibration and BOSU ball in people with Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy is a non-progressive neurodevelopmental disorder, also known as littles disease. The most common cause of physical and mental disabilities in the pediatric population. Cerebral means brain and palsy means weakness or problems in muscles. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Whole Body Vibration and BOSU ball
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jun 2024to 15 Aug 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic diplegic CP with GMFCS level I-II
- Age 6-12 years
- Both male and female.
- Able to understand command
Who cannot join
- Orthopedic surgery within 6 months
- Botulinum injection
- Parents refuse to participate
- Other diseases as Pneumonia
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Comparative Effects of Whole Body Vibration and BOSU Ball on Balance and Functional Mobility in Children With Spastic Cerebral Palsy
Cerebral palsy is a non-progressive neurodevelopmental disorder, also known as littles disease. The most common cause of physical and mental disabilities in the pediatric population. Cerebral means brain and palsy means weakness or problems in muscles. Spastic cerebral palsy is the common type of cerebral palsy characterized by spasticity or high muscle tone, results in stiffness etc.
This will be a randomized clinical trial, data will be collected from Sehat medical complex Lahore. Study will be conducted on 30 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 and 2 and those both male nd female, able to understand command will be included. Those diplegic spastic CP who have orthopedic intervention/surgery, botulinum toxin injection within past six months, or medical problems such as pneumonia that prevented children from participating in exercises will be excluded.
Read the detailed description
Group A: whole body vibration therapy group This group will be provided with whole body vibration therapy in spastic cerebral palsy children. Exercise will be conducted 3 times a week for 8 weeks. Pre and post session functional mobility and balance will be measured by pediatric balance scale and time up and go test. Along routine physical therapy such as stretching exercise of achilles tendon, hamstring muscles, hip flexors and adductors, shoulder internal rotators, and wrist flexors, pronators, and ulnar deviator etc.
Group B: BOSU ball training group This group will be provided with both sides up ball BOSU training in spastic cerebral palsy children. Exercise will be conducted 3 times a week for 8 weeks. Pre and post session functional mobility and balance will be measured by pediatric balance scale and time up and go test. Along routine physical therapy such as stretching exercise of achilles tendon, hamstring muscles, hip flexors and adductors, shoulder internal rotators, and wrist flexors, pronators, and ulnar deviator etc.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Whole Body Vibration, BOSU ball
- Keywords
- cerebral palsy, WBVT, bosu ball, functional mobility, balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body VibrationDevice
On vibration plate pate child will do kneeling, and one leg standing, standing horizontally or vertically. Along routine physical therapy such as stretching activities to keep up muscle elasticity particularly Achilles tendon, hamstring muscles, hip flexors and adductors, shoulder internal rotators, elbow and wrist flexors, pronators, and ulnar deviators, each stretch will be given for 30 seconds with 3 repetitions.Strength training to hip flexor, knee extensor, and ankle dorsiflexors for 15 minutes 3 times a week for 8 weeks. Session will be of 30 minutes
BOSU ballDevice
Exercises such as (1) standing on a BOSU ball while throwing and catching a ball (2) 1-legged standing (affected leg) on the BOSU ball while throwing and catching a ball with therapist support; and (3) small jumps on the BOSU ball. Three sets of 6 repetitions for each exercise will be perform every 2 weeks up to a maximum of 10 repetitions if the participants were still able to perform the training easily. Total dose of balance training in 1 session will be 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration Therapy | Experimental | This group will receive Whole Body Vibration Therapy Receives: Device: Whole Body Vibration |
| BOSU ball therapy | Experimental | This group will receive BOSU ball therapy Receives: Device: BOSU ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale
The (PBS) pediatric balance scale, a modification of the Berg Balance Scale, was developed as a balance measure for school-age children with mild-to-moderate motor impairments. It gives good test-retest and interrater reliability when used, ranged from 0.87 to 1.0.
Measured: 8 weeks
Timed Up & Go test
TUG is used to determine functional mobility.Functional mobility of children will be evaluated through timed get up and go (TUG) test and its results will be recorded. In this test, the duration of standing up from the chair, walking up to 3 m, returning, and sitting on the chair will be measured. It is a very valid and reliable tool 0.97 and 0.99.
Measured: 8 weeks
Functional Mobility Scale
FMS (functional mobility scale) is used to measure functional mobility and its results will be recorded. It has perfect test-retest reliability (κw=0.98-1.00)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start28 Jun 2024
- Primary completion8 Aug 2024
- Study completion15 Aug 2024
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 Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be randomized control trial in which non probability convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. group A will only receive Whole Body Vibration therapy and group B will only receive BOSU ball.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafsa Imtiaz, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407921
- Sponsor's protocol ID
- REC/RCR&AHS/23/07100
- Status last verified
- Sep 2024
- First submitted
- 6 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.
PubMed 25724849
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Whole Body Vibration and BOSU Ball on Balance and Functional Mobility in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06407921
- Acronym / sponsor ID
- REC/RCR&AHS/23/07100
- Conditions
- Spastic Cerebral Palsy
- Keywords
- cerebral palsy, WBVT, bosu ball, functional mobility, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 9 May 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.
Cerebral palsy is a non-progressive neurodevelopmental disorder, also known as littles disease. The most common cause of physical and mental disabilities in the pediatric population. Cerebral means brain and palsy means weakness or problems in muscles. Spastic cerebral palsy is the common type of cerebral palsy characterized by spasticity or high muscle tone, results in stiffness etc.
This will be a randomized clinical trial, data will be collected from Sehat medical complex Lahore. Study will be conducted on 30 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 and 2 and those both male nd female, able to understand command will be included. Those diplegic spastic CP who have orthopedic intervention/surgery, botulinum toxin injection within past six months, or medical problems such as pneumonia that prevented children from participating in exercises will be excluded.
Detailed description
Group A: whole body vibration therapy group This group will be provided with whole body vibration therapy in spastic cerebral palsy children. Exercise will be conducted 3 times a week for 8 weeks. Pre and post session functional mobility and balance will be measured by pediatric balance scale and time up and go test. Along routine physical therapy such as stretching exercise of achilles tendon, hamstring muscles, hip flexors and adductors, shoulder internal rotators, and wrist flexors, pronators, and ulnar deviator etc.
Group B: BOSU ball training group This group will be provided with both sides up ball BOSU training in spastic cerebral palsy children. Exercise will be conducted 3 times a week for 8 weeks. Pre and post session functional mobility and balance will be measured by pediatric balance scale and time up and go test. Along routine physical therapy such as stretching exercise of achilles tendon, hamstring muscles, hip flexors and adductors, shoulder internal rotators, and wrist flexors, pronators, and ulnar deviator etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be randomized control trial in which non probability convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. group A will only receive Whole Body Vibration therapy and group B will only receive BOSU ball.
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration Therapy | Experimental | Device: Whole Body VibrationThis group will receive Whole Body Vibration Therapy |
| BOSU ball therapy | Experimental | Device: BOSU ballThis group will receive BOSU ball therapy |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Spastic diplegic CP with GMFCS level I-II
- Age 6-12 years
- Both male and female.
- Able to understand command
Key exclusion criteria (4 listed)
- Orthopedic surgery within 6 months
- Botulinum injection
- Parents refuse to participate
- Other diseases as Pneumonia
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 |
|---|---|---|
| Whole Body VibrationOn vibration plate pate child will do kneeling, and one leg standing, standing horizontally or vertically. Along routine physical therapy such as stretching activities to keep up muscle elasticity particularly Achilles tendon, hamstring muscles, hip flexors and adductors, shoulder internal rotators, elbow and wrist flexors, pronators, and ulnar deviators, each stretch will be given for 30 seconds with 3 repetitions.Strength training to hip flexor, knee extensor, and ankle dorsiflexors for 15 minutes 3 times a week for 8 weeks. Session will be of 30 minutes | Device | Whole Body Vibration Therapy |
| BOSU ballExercises such as (1) standing on a BOSU ball while throwing and catching a ball (2) 1-legged standing (affected leg) on the BOSU ball while throwing and catching a ball with therapist support; and (3) small jumps on the BOSU ball. Three sets of 6 repetitions for each exercise will be perform every 2 weeks up to a maximum of 10 repetitions if the participants were still able to perform the training easily. Total dose of balance training in 1 session will be 15 minutes | Device | BOSU ball therapy |
Primary outcome
Pediatric Balance Scale
Time frame: 8 weeks
The (PBS) pediatric balance scale, a modification of the Berg Balance Scale, was developed as a balance measure for school-age children with mild-to-moderate motor impairments. It gives good test-retest and interrater reliability when used, ranged from 0.87 to 1.0.
Timed Up & Go test
Time frame: 8 weeks
TUG is used to determine functional mobility.Functional mobility of children will be evaluated through timed get up and go (TUG) test and its results will be recorded. In this test, the duration of standing up from the chair, walking up to 3 m, returning, and sitting on the chair will be measured. It is a very valid and reliable tool 0.97 and 0.99.
Functional Mobility Scale
Time frame: 8 weeks
FMS (functional mobility scale) is used to measure functional mobility and its results will be recorded. It has perfect test-retest reliability (κw=0.98-1.00)
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 19 Sep 2024.
- Background: PubMed 25724849Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.
- Individual participant dataSharing planned: No
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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.
Hafsa Imtiaz, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Vibration and BOSU ball in people with Spastic Cerebral Palsy, run by Riphah International University at 1 site 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Pediatric Balance Scale (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT06407921, 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 19 Sep 2024.