Cerebral PalsyCPNCT06709742
Effect of Goal-Oriented GMFM-88 Based Program in Cerebral Palsy.
A study testing Gross Motor Function Measure-88 Based Therapy in people with Cerebral Palsy and Quality of Life (QOL), run by Ziauddin University at 2 sites in Pakistan.
Trial summary
Cerebral Palsy (CP) is a infancy and early childhood disorder that results in motor impairment caused by static and non-progressive lesions in the brain. It has an impact on both the neurological and musculoskeletal systems of the bod. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Cerebral Palsy, Quality of Life (QOL), Balance
- What is being tested?
- Gross Motor Function Measure-88 Based Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Aug 2024to Mar 2025
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Diagnosed Cerebral Palsy,
- Age 5-16 years,
- GMFCS Level I, II \& III,
- Able to understand instructions,
- With/ without any assistive devices.
Who cannot join
- • CP children with any respiratory disorders,
- Undergoing surgery within the past 6 months,
- Botulinum injection within the last 6 months,
- Unstable seizures,
- Co-existing condition (ADHD, Metabolic Disorder, Progressive disorder),
- Any other co-morbid causing difficulty in performing tasks.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
ACELP Institute of Child Development
Karachi, Sindh, 07553
Dar-ul-Sukun
Karachi, Sindh, 74200
About this study
Official title: Effect of Goal-Oriented GMFM-88 Based Program on Enhancing Gross Motor Function, Balance and Quality of Life Among Children with Cerebral Palsy
Cerebral Palsy (CP) is a infancy and early childhood disorder that results in motor impairment caused by static and non-progressive lesions in the brain. It has an impact on both the neurological and musculoskeletal systems of the bod. According to the Cerebral Palsy Alliance Research Foundation (CPARF) \& WHO Cerebral Palsy Statistics 2023, approximately 17 million individuals experience some form of CP. This data underscores a notable prevalence rate of 1.5 cases per 1,000 live births within the High-Income Countries (HICs), limited but growing data are obtained from both the Lower Middle-Income Countries (LMICs. The incidence of CP among children in the Swabi district of Khyber Pakhtunkhwa, Pakistan, was 1.22 per 1000 live births. The overall prevalence in Pakistan is still not known, but according to recent documentation, it is estimated to be 4 out of every 1000 live births.
The symptoms in CP encompassing atypical muscle contractions, alteration in posture and limitations in movement and physical activity. Furthermore,these symptoms are accompanied by disruptions in sensory perception and cognitive processing along with the challenges of communication, behavioral issues, epileptic seizures and secondary musculoskeletal complications. Motor deficit is present in 65.56% percent of CP cases as well as balance is impaired in most of the cases, and different impairments combinedly decreased overall quality of life (QOL). Because activities of daily living are decreased which in a result increases the caregiver's workload.Despite such a high prevalence of CP, there is still no standardized treatment approach implemented in the clinical settings due to their individualized needs and varying degrees of impairment.
Consequently, our study seeks to address this gap by investigating the effect of Goal-Oriented individualized GMFM based programs on enhancing gross motor function, balance and quality of life. By elucidating the potential benefits of intervention, our study aims to contribute to the optimization of therapeutic approaches tailored to the different needs of children with CP.
Read the detailed description
A total number of 47 participants will be included in the study. A written informed assent will be taken from the parent or guardian of the child prior to intervention which includes a detailed description of the method, procedure, benefits and risks of the training. Children will perform GMFM-88 based individualized goal-oriented training selected with the concern of family and caregivers. All children will be assessed initially based on GMFCS level and categorized into levels I, II \& III. Baseline assessment will be carried out before the first session of all the recruited children using GMFM-88 to assess gross motor function, Kids-Balance Evaluation-System (Kids-BESTest) for balance \& Quality of Life assessed through CPQOL questionnaire respectively. Children will be reassessed after the 16 weeks of training and re-evaluated on the 18th for residual effects after completion of 16 weeks of training. The intervention will be given 3 times per week for a duration of 40-45 minutes for each session for 16 weeks (In addition, a written home program will be given to the parents/guardians of the participants to carry out the program at home). To ensure that the parents are regularly performing exercises a WhatsApp group will be created for sending reminders. Parents will be appreciated and motivated through messages. After completing the home program parents will send a message.
Goal Oriented Exercise Protocol:
After screening the children will perform GMFM-88 based goal-oriented training assigned by trained therapists such as items of dimension D are related to standing and dimension E items are related to walking and running. 5-10 minutes of warm-up provided preliminary. Including stretching, bridging, upper and lower limb range of motions. Children will be assessed initially by using GMFM-88 and selecting specific items for individuals according to his/her needs with the help of experts and family. At least 3 items will be selected for each subject in which they score less such that 0, 1 or 2. Training based on those specific items will be given to the children. This is goal-oriented training in which, according to the needs of children training will be provided. There are 13 items in dimension D and 24 items in dimension E. At the end of the study, we analyze the children's number on each item and their improvement after the training.
Dimension D: Standing Items of dimension included such as maintaining standing with and without arms, lifting a single leg from the floor, sitting to stand, attaining standing from high kneeling, squats and picking objects from the floor.
Dimension E: Walking, Running \& Jumping
Dimension E included items such as cruising, forward and backward walking, turning 180 degrees, walking on parallel and straight lines, crossing hurdles, running, kicking ball, jumping, hopping, ascending and descending stairs.MATCHING ACTIVITIES:
- DIMENSION D (STANDING):
- The child stands with the wall support at the back and engages in catch and throw activities with his peers/therapist.
- The child stands against the wall with a table in front to be engaged in the activity.
- The child is asked to kick the ball with/without holding a parallel bar.
- For one leg standing balance, the child's one leg will be placed on the football while the other on the floor.
- Placing alternate feet on the bench of 0.5 feet in height.
- Sit to stand from the 1-foot high bench, a key point of control /assistance as needed.
- DIMENSION E (WALKING \& RUNNING):
- Walking holding onto the parallel bar.
- Walking while holding a book/toy in hand.
- Motivate the child to climb up and down stairs starting with rail support and progressing to without rail support. Initially with both feet and then progress to a single foot.
- Cruising on the left and right side using furniture for support.
- Crossing over the small obstacles of varying height (child's ankle, mid calf \& knee level).
- Making figures of 8 while walking.
- Jumping on the same mark.
- Hold the parallel bar with hand and kick the ball.
- Conditions
- Cerebral Palsy, Quality of Life (QOL), Balance, CP
- Being tested
- Gross Motor Function Measure-88 Based Therapy
- Keywords
- Cerebral Palsy, Gross motor function, Balance, Quality of Life, CP, GMFM-88, BESTest, CP QOL
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gross Motor Function Measure-88 Based TherapyOther
Also called GMFM-88 Based Therapy
Children will be assessed initially by using GMFM-88 and selecting specific items for individuals according to his/her needs with the help of experts and family. At least 3 items will be selected for each subject in which they score less such that 0, 1 or 2. Training based on those specific items will be given to the children. This is goal-oriented training in which, according to the needs of children training will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The Intervention based on GMFM-88 items will be given 3 times per week for a duration of 40-45 minutes for each session for 16 weeks. Receives: Other: Gross Motor Function Measure-88 Based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function
The GMFM-88 (Gross Motor Function Measure-88) is a scale used to assess gross motor function in children with CP.
Measured: At Baseline
Gross Motor Function
The GMFM-88 (Gross Motor Function Measure-88) is a scale used to assess gross motor function in children with CP.
Measured: Through study completion, at 16th week
Gross Motor Function
The GMFM-88 (Gross Motor Function Measure-88) is a scale used to assess gross motor function in children with CP.
Measured: followup of 2 weeks.
Balance
The Kids BESTest Scale (Balance Evaluation Systems Test) is used to assess balance in children with CP.
Measured: At Baseline
Balance
The Kids BESTest Scale (Balance Evaluation Systems Test) is used to assess balance in children with CP.
Measured: Through study completion, at 16th week
Balance
The Kids BESTest Scale (Balance Evaluation Systems Test) is used to assess balance in children with CP.
Measured: followup of 2 weeks.
Quality Of Life
The CP QOL (Cerebral Palsy Quality of Life) questionnaire is used to assess the quality of life in children with CP.
Measured: At Baseline
Quality Of Life
The CP QOL (Cerebral Palsy Quality of Life) questionnaire is used to assess the quality of life in children with CP.
Measured: Through study completion, at 16th week
Quality Of Life
The CP QOL (Cerebral Palsy Quality of Life) questionnaire is used to assess the quality of life in children with CP.
Measured: followup of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start15 Aug 2024
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ifra Neelum, Ziauddin University
- Investigators
- Dr.Amna Aamir Khan, PhD, Study director, Ziauddin College of Physical Therapy, Ziauddin UniversityIfra Neelum, MPhil, Principal investigator, Ziauddin College of Physical Therapy, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709742
- Sponsor's protocol ID
- 8750524INREH
- Acronym
- CP
- Status last verified
- Sep 2024
- First submitted
- 18 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee M, Ko Y, Shin MM, Lee W. The effects of progressive functional training on lower limb muscle architecture and motor function in children with spastic cerebral palsy. J Phys Ther Sci. 2015 May;27(5):1581-4. doi: 10.1589/jpts.27.1581. Epub 2015 May 26.
PubMed 26157267Paul S, Nahar A, Bhagawati M, Kunwar AJ. A Review on Recent Advances of Cerebral Palsy. Oxid Med Cell Longev. 2022 Jul 30;2022:2622310. doi: 10.1155/2022/2622310. eCollection 2022.
PubMed 35941906McIntyre S, Goldsmith S, Webb A, Ehlinger V, Hollung SJ, McConnell K, Arnaud C, Smithers-Sheedy H, Oskoui M, Khandaker G, Himmelmann K; Global CP Prevalence Group*. Global prevalence of cerebral palsy: A systematic analysis. Dev Med Child Neurol. 2022 Dec;64(12):1494-1506. doi: 10.1111/dmcn.15346. Epub 2022 Aug 11.
PubMed 35952356Cooper MS, Fahey MC, Mackay MT. Making waves: The changing tide of cerebral palsy. J Paediatr Child Health. 2022 Nov;58(11):1929-1934. doi: 10.1111/jpc.16186. Epub 2022 Sep 6.
PubMed 36066306Abd-Elfattah HM, Ameen FH, Elkalla RA, Aly SM, Abd-Elrahman NAF. Loaded Functional Strength Training versus Traditional Physical Therapy on Hip and Knee Extensors Strength and Function Walking Capacity in Children with Hemiplegic Cerebral Palsy: Randomized Comparative Study. Children (Basel). 2022 Jun 24;9(7):946. doi: 10.3390/children9070946.
PubMed 35883930
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Goal-Oriented GMFM-88 Based Program on Enhancing Gross Motor Function, Balance and Quality of Life Among Children with Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06709742
- Acronym / sponsor ID
- CP / 8750524INREH
- Conditions
- Cerebral Palsy, Quality of Life (QOL), Balance, CP
- Keywords
- Cerebral Palsy, Gross motor function, Balance, Quality of Life, CP, GMFM-88, BESTest, CP QOL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 29 Nov 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 (CP) is a infancy and early childhood disorder that results in motor impairment caused by static and non-progressive lesions in the brain. It has an impact on both the neurological and musculoskeletal systems of the bod. According to the Cerebral Palsy Alliance Research Foundation (CPARF) \& WHO Cerebral Palsy Statistics 2023, approximately 17 million individuals experience some form of CP. This data underscores a notable prevalence rate of 1.5 cases per 1,000 live births within the High-Income Countries (HICs), limited but growing data are obtained from both the Lower Middle-Income Countries (LMICs. The incidence of CP among children in the Swabi district of Khyber Pakhtunkhwa, Pakistan, was 1.22 per 1000 live births. The overall prevalence in Pakistan is still not known, but according to recent documentation, it is estimated to be 4 out of every 1000 live births.
The symptoms in CP encompassing atypical muscle contractions, alteration in posture and limitations in movement and physical activity. Furthermore,these symptoms are accompanied by disruptions in sensory perception and cognitive processing along with the challenges of communication, behavioral issues, epileptic seizures and secondary musculoskeletal complications. Motor deficit is present in 65.56% percent of CP cases as well as balance is impaired in most of the cases, and different impairments combinedly decreased overall quality of life (QOL). Because activities of daily living are decreased which in a result increases the caregiver's workload.Despite such a high prevalence of CP, there is still no standardized treatment approach implemented in the clinical settings due to their individualized needs and varying degrees of impairment.
Consequently, our study seeks to address this gap by investigating the effect of Goal-Oriented individualized GMFM based programs on enhancing gross motor function, balance and quality of life. By elucidating the potential benefits of intervention, our study aims to contribute to the optimization of therapeutic approaches tailored to the different needs of children with CP.
Detailed description
A total number of 47 participants will be included in the study. A written informed assent will be taken from the parent or guardian of the child prior to intervention which includes a detailed description of the method, procedure, benefits and risks of the training. Children will perform GMFM-88 based individualized goal-oriented training selected with the concern of family and caregivers. All children will be assessed initially based on GMFCS level and categorized into levels I, II \& III. Baseline assessment will be carried out before the first session of all the recruited children using GMFM-88 to assess gross motor function, Kids-Balance Evaluation-System (Kids-BESTest) for balance \& Quality of Life assessed through CPQOL questionnaire respectively. Children will be reassessed after the 16 weeks of training and re-evaluated on the 18th for residual effects after completion of 16 weeks of training. The intervention will be given 3 times per week for a duration of 40-45 minutes for each session for 16 weeks (In addition, a written home program will be given to the parents/guardians of the participants to carry out the program at home). To ensure that the parents are regularly performing exercises a WhatsApp group will be created for sending reminders. Parents will be appreciated and motivated through messages. After completing the home program parents will send a message.
Goal Oriented Exercise Protocol:
After screening the children will perform GMFM-88 based goal-oriented training assigned by trained therapists such as items of dimension D are related to standing and dimension E items are related to walking and running. 5-10 minutes of warm-up provided preliminary. Including stretching, bridging, upper and lower limb range of motions. Children will be assessed initially by using GMFM-88 and selecting specific items for individuals according to his/her needs with the help of experts and family. At least 3 items will be selected for each subject in which they score less such that 0, 1 or 2. Training based on those specific items will be given to the children. This is goal-oriented training in which, according to the needs of children training will be provided. There are 13 items in dimension D and 24 items in dimension E. At the end of the study, we analyze the children's number on each item and their improvement after the training.
Dimension D: Standing Items of dimension included such as maintaining standing with and without arms, lifting a single leg from the floor, sitting to stand, attaining standing from high kneeling, squats and picking objects from the floor.
Dimension E: Walking, Running \& Jumping
Dimension E included items such as cruising, forward and backward walking, turning 180 degrees, walking on parallel and straight lines, crossing hurdles, running, kicking ball, jumping, hopping, ascending and descending stairs.MATCHING ACTIVITIES:
- DIMENSION D (STANDING):
- The child stands with the wall support at the back and engages in catch and throw activities with his peers/therapist.
- The child stands against the wall with a table in front to be engaged in the activity.
- The child is asked to kick the ball with/without holding a parallel bar.
- For one leg standing balance, the child's one leg will be placed on the football while the other on the floor.
- Placing alternate feet on the bench of 0.5 feet in height.
- Sit to stand from the 1-foot high bench, a key point of control /assistance as needed.
- DIMENSION E (WALKING \& RUNNING):
- Walking holding onto the parallel bar.
- Walking while holding a book/toy in hand.
- Motivate the child to climb up and down stairs starting with rail support and progressing to without rail support. Initially with both feet and then progress to a single foot.
- Cruising on the left and right side using furniture for support.
- Crossing over the small obstacles of varying height (child's ankle, mid calf \& knee level).
- Making figures of 8 while walking.
- Jumping on the same mark.
- Hold the parallel bar with hand and kick the ball.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Gross Motor Function Measure-88 Based TherapyThe Intervention based on GMFM-88 items will be given 3 times per week for a duration of 40-45 minutes for each session for 16 weeks. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Diagnosed Cerebral Palsy,
Key exclusion criteria (6 listed)
- • CP children with any respiratory disorders,
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 |
|---|---|---|
| Gross Motor Function Measure-88 Based TherapyAlso: GMFM-88 Based TherapyChildren will be assessed initially by using GMFM-88 and selecting specific items for individuals according to his/her needs with the help of experts and family. At least 3 items will be selected for each subject in which they score less such that 0, 1 or 2. Training based on those specific items will be given to the children. This is goal-oriented training in which, according to the needs of children training will be provided. | Other | Intervention Group |
Primary outcome
Gross Motor Function
Time frame: At Baseline
The GMFM-88 (Gross Motor Function Measure-88) is a scale used to assess gross motor function in children with CP.
Gross Motor Function
Time frame: Through study completion, at 16th week
The GMFM-88 (Gross Motor Function Measure-88) is a scale used to assess gross motor function in children with CP.
Gross Motor Function
Time frame: followup of 2 weeks.
The GMFM-88 (Gross Motor Function Measure-88) is a scale used to assess gross motor function in children with CP.
Balance
Time frame: At Baseline
The Kids BESTest Scale (Balance Evaluation Systems Test) is used to assess balance in children with CP.
Balance
Time frame: Through study completion, at 16th week
The Kids BESTest Scale (Balance Evaluation Systems Test) is used to assess balance in children with CP.
Balance
Time frame: followup of 2 weeks.
The Kids BESTest Scale (Balance Evaluation Systems Test) is used to assess balance in children with CP.
Quality Of Life
Time frame: At Baseline
The CP QOL (Cerebral Palsy Quality of Life) questionnaire is used to assess the quality of life in children with CP.
Quality Of Life
Time frame: Through study completion, at 16th week
The CP QOL (Cerebral Palsy Quality of Life) questionnaire is used to assess the quality of life in children with CP.
Quality Of Life
Time frame: followup of 2 weeks.
The CP QOL (Cerebral Palsy Quality of Life) questionnaire is used to assess the quality of life in children with CP.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 26157267Lee M, Ko Y, Shin MM, Lee W. The effects of progressive functional training on lower limb muscle architecture and motor function in children with spastic cerebral palsy. J Phys Ther Sci. 2015 May;27(5):1581-4. doi: 10.1589/jpts.27.1581. Epub 2015 May 26.
- Background: PubMed 35941906Paul S, Nahar A, Bhagawati M, Kunwar AJ. A Review on Recent Advances of Cerebral Palsy. Oxid Med Cell Longev. 2022 Jul 30;2022:2622310. doi: 10.1155/2022/2622310. eCollection 2022.
- Background: PubMed 35952356McIntyre S, Goldsmith S, Webb A, Ehlinger V, Hollung SJ, McConnell K, Arnaud C, Smithers-Sheedy H, Oskoui M, Khandaker G, Himmelmann K; Global CP Prevalence Group*. Global prevalence of cerebral palsy: A systematic analysis. Dev Med Child Neurol. 2022 Dec;64(12):1494-1506. doi: 10.1111/dmcn.15346. Epub 2022 Aug 11.
- Background: PubMed 36066306Cooper MS, Fahey MC, Mackay MT. Making waves: The changing tide of cerebral palsy. J Paediatr Child Health. 2022 Nov;58(11):1929-1934. doi: 10.1111/jpc.16186. Epub 2022 Sep 6.
- Background: PubMed 35883930Abd-Elfattah HM, Ameen FH, Elkalla RA, Aly SM, Abd-Elrahman NAF. Loaded Functional Strength Training versus Traditional Physical Therapy on Hip and Knee Extensors Strength and Function Walking Capacity in Children with Hemiplegic Cerebral Palsy: Randomized Comparative Study. Children (Basel). 2022 Jun 24;9(7):946. doi: 10.3390/children9070946.
- 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.
Dr.Amna Aamir Khan, PhD study director
Ziauddin College of Physical Therapy, Ziauddin University
Ifra Neelum, MPhil principal investigator
Ziauddin College of Physical Therapy, Ziauddin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gross Motor Function Measure-88 Based Therapy in people with Cerebral Palsy and Quality of Life (QOL), run by Ziauddin 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 5 inclusion and 6 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 29 Nov 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?
Gross Motor Function (time frame: At Baseline). The study lists 9 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 NCT06709742, which also lists 5 linked publications.
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 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.