Cerebral PalsyNCT05763212
Reverse Walking With And Without Whole Body Vibration in Children With Cerebral Palsy
A study testing Reverse Walking+Baseline treatment and Whole Body Vibration + Reverse Walking+Baseline treatment in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of reverse walking with and without Whole-body vibration on postural balance in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Reverse Walking+Baseline treatment and Whole Body Vibration + Reverse Walking+Baseline treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 13 May 2022to 30 Mar 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6-12 years
- Confirm diagnosis of Cerebral Palsy
- GMFCS level I \& II
- Both genders (28)
Who cannot join
- o Visual impairment
- Patients who can't follow command
- Hearing impairment
- Malignancy
- Infection (such as Osteomyelitis)
- Inflammatory arthritis
Show all 9Show fewer
- Lower extremity bones fracture
- Cardiovascular disease
- Traumatic cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Reverse Walking With And Without Whole Body Vibration On Postural Balance And Quality Of Life In Children With Cerebral Palsy
To determine the effects of reverse walking with and without Whole-body vibration on postural balance in children with cerebral palsy.
Read the detailed description
Current study concluded that reverse walking with and without whole body vibration were effective in improving postural balance, reach and quality of life in cerebral palsy children. However (whole body vibration+ reverse walking) provides more clinical benefits than reverse walking alone in improving postural balance, side reach and quality of life. Whereas both techniques were equally effective in improving forward reach in cerebral palsy children.
- Conditions
- Cerebral Palsy
- Being tested
- Reverse Walking+Baseline treatment, Whole Body Vibration + Reverse Walking+Baseline treatment
- Keywords
- postural 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.
Reverse Walking+Baseline treatmentOther
Reverse Walking+Baseline treatment
Whole Body Vibration + Reverse Walking+Baseline treatmentOther
Whole Body Vibration + Reverse Walking+Baseline treatment
| Study group | Role | What they receive |
|---|---|---|
| Reverse Walking+Baseline treatment | Active comparator | Conventional treatment was given then received Reverse Walking Training which was provided for 7 min per set, with approximately 3 min of inter-set rest, for a total training duration of 60 min/day, 3 days/week for 3 successive months . Receives: Other: Reverse Walking+Baseline treatment |
| Whole Body Vibration + Reverse Walking+Baseline treatment | Experimental | Conventional Physical Therapy Treatment was given as a baseline treatment which includes Stretching, Range of motion exercises, and Strengthening exercises) performed for 10 min.
Reverse Walking Training which was provided for 7 min per set, with approximately 3 min of inter-set rest, for a total training duration of 30 min/day, 3 days/week for 3 successive months After that Group received Whole Body Vibration including three vibration sessions per week for three months. The participants have to carry out each set of vibration for 2 min in the first month, and then it was increased to 3 min in the second and 5 min in the third month. The rest period between each set was 1 min in the first month, then it became half a minute in the second and third month. Total training duration is 30 min/day, 3 days/week for 3 successive months. Receives: Other: Whole Body Vibration + Reverse Walking+Baseline treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale;
The pediatric balance scale is the modified version of the berg balance scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
Measured: 12th week
Pediatric Reach Test (PRT) / Functional Reach Test (FRT)
The Pediatric Reach Test (PRT) is a modified form of the Functional Reach Test (FRT). The PRT measures side reaching as well as forward reaching in both sitting and standing positions.
Measured: 12th week
Secondary outcomes (1)
CP QOL-Child
The CP QOL-Child was designed to assess the quality of life of children aged 4-12 years. There are two versions, including a primary caregiver/parent report for children aged 4 to 12 years; and a self-report for children aged 9 to 12 years(10).
GMFCS level I \& II GMFCS Level I
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start13 May 2022
- Primary completion16 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fareeha kausar, pp-Dpt, Principal investigator, Riphah international university pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763212
- Sponsor's protocol ID
- REC/RCR & AHS/22/0739
- Status last verified
- Dec 2023
- First submitted
- 28 Feb 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Reverse Walking With And Without Whole Body Vibration On Postural Balance And Quality Of Life In Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05763212
- Acronym / sponsor ID
- REC/RCR & AHS/22/0739
- Conditions
- Cerebral Palsy
- Keywords
- postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 10 Mar 2023 (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.
To determine the effects of reverse walking with and without Whole-body vibration on postural balance in children with cerebral palsy.
Detailed description
Current study concluded that reverse walking with and without whole body vibration were effective in improving postural balance, reach and quality of life in cerebral palsy children. However (whole body vibration+ reverse walking) provides more clinical benefits than reverse walking alone in improving postural balance, side reach and quality of life. Whereas both techniques were equally effective in improving forward reach in cerebral palsy children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reverse Walking+Baseline treatment | Active comparator | Other: Reverse Walking+Baseline treatmentConventional treatment was given then received Reverse Walking Training which was provided for 7 min per set, with approximately 3 min of inter-set rest, for a total training duration of 60 min/day, 3 days/week for 3 successive months . |
| Whole Body Vibration + Reverse Walking+Baseline treatment | Experimental | Other: Whole Body Vibration + Reverse Walking+Baseline treatmentConventional Physical Therapy Treatment was given as a baseline treatment which includes Stretching, Range of motion exercises, and Strengthening exercises) performed for 10 min. Reverse Walking Training which was provided for 7 min per set, with approximately 3 min of inter-set rest, for a total training duration of 30 min/day, 3 days/week for 3 successive months After that Group received Whole Body Vibration including three vibration sessions per week for three months. The participants have to carry out each set of vibration for 2 min in the first month, and then it was increased to 3 min in the second and 5 min in the third month. The rest period between each set was 1 min in the first month, then it became half a minute in the second and third month. Total training duration is 30 min/day, 3 days/week for 3 successive months. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 6-12 years
- Confirm diagnosis of Cerebral Palsy
- GMFCS level I \& II
- Both genders (28)
Key exclusion criteria (9 listed)
- o Visual impairment
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 |
|---|---|---|
| Reverse Walking+Baseline treatmentReverse Walking+Baseline treatment | Other | Reverse Walking+Baseline treatment |
| Whole Body Vibration + Reverse Walking+Baseline treatmentWhole Body Vibration + Reverse Walking+Baseline treatment | Other | Whole Body Vibration + Reverse Walking+Baseline treatment |
Primary outcome
Pediatric Balance Scale;
Time frame: 12th week
The pediatric balance scale is the modified version of the berg balance scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
Pediatric Reach Test (PRT) / Functional Reach Test (FRT)
Time frame: 12th week
The Pediatric Reach Test (PRT) is a modified form of the Functional Reach Test (FRT). The PRT measures side reaching as well as forward reaching in both sitting and standing positions.
1 secondary outcome
CP QOL-Child
Time frame: 12th week
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 29 Dec 2023.
- 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.
fareeha kausar, pp-Dpt principal investigator
Riphah international university pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse Walking+Baseline treatment and Whole Body Vibration + Reverse Walking+Baseline treatment in people with 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 9 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 29 Dec 2023. 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: 12th week). The study lists 2 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 29 Dec 2023.