Cerebral PalsyNCT06667388
Effect of Backward Walking Training vs Forward Walking Training to Improve Balance and Mobility in Children With CP
A study testing Group A and Grojup B in people with Cerebral Palsy, run by Superior University at 1 site in Pakistan.
Trial summary
Children with cerebral palsy frequently experience balance issues and gait impairments; gait training is a crucial component of their rehabilitation because it greatly enhances the children's socialisation and quality of life. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Group A and Grojup B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Only CP patients will be included.
- Patient will be included from Bahawalpur only.
- Patient will be included having minimum age of 10 year.
Who cannot join
- Other cities patient will not be included.
- Patient less than 10 years age.
- Patient suffering from other neurological conditions.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
sadiq abbasi hospital bwp Contact: jangi wala road BWP
Chak Eighty-seven -Twelve Left
About this study
Official title: Effect of Backward Walking Training Versus Forward Walking Training Program to Improve Balance and Mobility in Children With Cerebral Palsy
Children with cerebral palsy frequently experience balance issues and gait impairments; gait training is a crucial component of their rehabilitation because it greatly enhances the children's socialisation and quality of life.
Read the detailed description
Since there is no known cure for cerebral palsy, the focus of treatment is shifting to enhancing activities like walking and self-care. Enabling the child with cerebral palsy is the ultimate goal of therapy.
- Conditions
- Cerebral Palsy
- Being tested
- Group A, Grojup B
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ADiagnostic test
each participant of this groups will receive 4 weeks of FWT and 4 weeks of BWT (the training order of A group will FWT and BWT), with a washout period of 2 weeks during the post-intervention phase of the 1st period and the pre-intervention phase for the 2nd period.
Grojup BCombination product
each participant of B group will receive 4 weeks of BWT and 4 weeks of FWT (the training order of group B will be BWT and FWT, opposite to group A), with a washout period of 2 weeks during the post-intervention phase of the 1st period and the pre-intervention phase for the 2nd period.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Diagnostic Test: Group A |
| Group B | Active comparator | Not described Receives: Combination Product: Grojup B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Functional Independent Measure for Children (WeeFIM)
The Independence Measure for Children (WeeFIM®) is frequently used as a multiple tool in pediatric clinics to assess the self-care, mobility, and psychological well-being of many groups of children, including those with developmental or developmental disabilities.
The Functional Independence Measure for Children (WeeFIM) is an 18-item, seven-level ordinal scale instrument used to assess a child's typical and consistent performance.Children 0 to <3 years no WeeFIM (or FIM) is required. Children 3 to <12
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 posted31 Oct 2024
- Study start1 Nov 2023
- Primary completion1 Jun 2024
- Study completion15 Nov 2024 (estimated)
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.
- 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
- 14 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
- NCT06667388
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/746
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 31 Oct 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 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Backward Walking Training Versus Forward Walking Training Program to Improve Balance and Mobility in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06667388
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/746
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 31 Oct 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.
Children with cerebral palsy frequently experience balance issues and gait impairments; gait training is a crucial component of their rehabilitation because it greatly enhances the children's socialisation and quality of life.
Detailed description
Since there is no known cure for cerebral palsy, the focus of treatment is shifting to enhancing activities like walking and self-care. Enabling the child with cerebral palsy is the ultimate goal of therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Diagnostic Test: Group A |
| Group B | Active comparator | Combination Product: Grojup B |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Only CP patients will be included.
- Patient will be included from Bahawalpur only.
- Patient will be included having minimum age of 10 year.
Key exclusion criteria (3 listed)
- Other cities patient will not be included.
- Patient less than 10 years age.
- Patient suffering from other neurological conditions.
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 |
|---|---|---|
| Group Aeach participant of this groups will receive 4 weeks of FWT and 4 weeks of BWT (the training order of A group will FWT and BWT), with a washout period of 2 weeks during the post-intervention phase of the 1st period and the pre-intervention phase for the 2nd period. | Diagnostic test | Group A |
| Grojup Beach participant of B group will receive 4 weeks of BWT and 4 weeks of FWT (the training order of group B will be BWT and FWT, opposite to group A), with a washout period of 2 weeks during the post-intervention phase of the 1st period and the pre-intervention phase for the 2nd period. | Combination product | Group B |
Primary outcome
Pediatric Functional Independent Measure for Children (WeeFIM)
Time frame: 12 Months
The Independence Measure for Children (WeeFIM®) is frequently used as a multiple tool in pediatric clinics to assess the self-care, mobility, and psychological well-being of many groups of children, including those with developmental or developmental disabilities. The Functional Independence Measure for Children (WeeFIM) is an 18-item, seven-level ordinal scale instrument used to assess a child's typical and consistent performance.Children 0 to <3 years no WeeFIM (or FIM) is required. Children 3 to <12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Grojup B in people with Cerebral Palsy, run by Superior 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 31 Oct 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?
This study is still under way. Results are not available in the source record yet.
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 Functional Independent Measure for Children (WeeFIM) (time frame: 12 Months). 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 31 Oct 2024.