Cerebral PalsyNCT06303440
Effects of Virtual Reality Versus Motor Imagery in Children With Cerebral Palsy
A study testing Routine Physical Therapy+ Balance Training, Virtual Reality+ Routine Physical Therapy and Motor Imagery+ Routine Physical Therapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy is a neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Routine Physical Therapy+ Balance Training, Virtual Reality+ Routine Physical Therapy and Motor Imagery+ Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2024to 31 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of 7-12 years of both genders, Children with Mini Mental Scale score >24.
- Children with Gross motor function classification system (GMFCS) level I and II and able to follow and accept verbal instruction.
- Exclusion Criteria: History of any Visual and Hearing Impairments, Virtual game phobia.
- History of nerve, muscle, bone and joint diseases that seriously affect the movement function of the limbs and Children with history of severe cardiopulmonary disease, History of epilepsy, History of Fixed deformity of Lower limb. History of orthopaedic surgery and botulinum toxin injection.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54660
About this study
Official title: Effects of Virtual Reality Versus Motor Imagery on Balance, Gross Motor Function and Activities of Daily Living in Children With Cerebral Palsy.
Cerebral palsy is a neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Motor Imagery is an ability to engage in the mental representation of a task consciously without generating a voluntary movement. The aim of this study is to determine the comparative effects of Virtual Reality and Motor Imagery on balance, gross motor function and activities of daily living in children with cerebral palsy.
Read the detailed description
This randomized controlled trial will be conducted at Rising Sun Institute. The sample size calculated for this trial will be 75. The participants will be randomly allocated using online randomization tool into three groups; Group A will receive routine physical therapy (PT) for 30 minutes with additional selected exercises for 15 minutes, Group B will receive VR training for 15 minutes with routine PT for 30 minutes, and Group C will receive MI for 15 minutes and routine PT for 30 minutes. Each participant will receive treatment for three days on alternative days per week for 12 weeks. Gross Motor Function Scale (GMFCS) will be used for balance, Bruininks-Oseretsky Test of motor function Proficiency-2 (BOT-2 ) for motor function, and WeeFIM scale for ADLs at baseline, 8th week, 12th week, and at 16th week after discontinuation of treatment.
- Conditions
- Cerebral Palsy
- Being tested
- Routine Physical Therapy+ Balance Training, Virtual Reality+ Routine Physical Therapy, Motor Imagery+ Routine Physical Therapy
- Keywords
- cerebral palsy, Motor control, activities of daily living, randomized controlled trial
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Physical Therapy+ Balance TrainingOther
Each session will be begun with routine PT treatment and lasted for 45 minutes in total. To start, the participants will be asked to do warm-up exercises, sitting comfortably on a chair with their backs and feet well supported, the participants will be instructed to breathe in and out. Warm-up exercises will be carried out for 5 minutes. Stretching exercises will be performed for 15 minutes per session, and stretches were held for 30 seconds with four repetitions of each of the following areas, shoulder flexors, elbow and wrist flexors, hip flexors, hip adductors, knee flexors, and calf, 10 seconds of rest period will be added after stretching of one muscle group. Participants will have a 15 minutes session of exercises neck holding on form roller for 1 minute with two repetitions, astride-sitting on foam roller for 2 minutes with four repetitions, weight on both hands on gym ball for 1 minute with two repetitions and hip adductors strengthening for 1 minute with three repetitions.
Virtual Reality+ Routine Physical TherapyOther
The exercises will be selected, and the difficulty level will be gradually increased according to participant's performance. Starting from the penguin slide, they will progress to table tilt. Initially, each game will be played for 2 minutes per session. With the progression of performance, 4 minutes of table tilt will be added. While playing this game, a typical mobility pattern will be initiated, and balance will be improved. In the same week, the subjects performed single-leg extensions for 1 minutes. In the following weeks, Balance Bubble, Advanced step, and Basic Run will be added to the plan. The participants will perform these activities for 7 minutes per session. Treatment sessions then progressed to motor function games, including bowling, tennis, kicking, and boxing (least challenging to most challenging), with most treatment sessions ending with boxing will be provided for 7 minutes and routine physical therapy for 30 minutes as explained in control group.
Motor Imagery+ Routine Physical TherapyOther
The 15 minutes of Motor Imagery session will be provided to participants. It's a three step process that will be used to incorporate the technique.
Step I, The self-recorded videos of the principal researcher performing a normal movements will be shown to participant.
Step II, The participants will be asked to imagine movement with eyes closed, and breathe deeply.
Step III The participants will be asked to perform the movement you watched in video and routine physical therapy of 30 minutes will be provided.
During the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Routine Physical Therapy+ Balance Training) | Other | The children will be provided with Routine Physical Therapy and Balance Training.
Balance exercises will be provided for 15 minutes and 30 minutes of Routine physical therapy will be as strengthening and stretching exercises. Receives: Other: Routine Physical Therapy+ Balance Training |
| Group B (Virtual Reality + Routine Physical Therapy) | Experimental | The VR system consisted of a wall-mounted display, a Nintendo Wii box, a Wii remote, and a Wii Fit board. The participants will be instructed to stand on Wii Fit board while interacting with the VR system and playing the selected games and routine physical therapy of 30 minutes will be provided. Receives: Other: Virtual Reality+ Routine Physical Therapy |
| Group C (Motor Imagery+ Routine Physical Therapy) | Experimental | During the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video Receives: Other: Motor Imagery+ Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Classification System
Gross Motor Function Classification System will be used to measure balance
Measured: 12 weeks
Bruininks-Oseretsky Test of motor function Proficiency-2
It will be measured with Bruininks-Oseretsky Test of motor function Proficiency-2 for motor function.
Measured: 12 Weeks
Functional Independence Measure for Children
Functional Independence Measure for Children scale will be used to determine the Activities of Daily Living improvement.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start25 Feb 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, PhD-PT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303440
- Sponsor's protocol ID
- REC/RCR&AHS/23/0288
- Status last verified
- Oct 2024
- First submitted
- 4 Mar 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu J, Loprinzi PD, Ren Z. The Rehabilitative Effects of Virtual Reality Games on Balance Performance among Children with Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2019 Oct 28;16(21):4161. doi: 10.3390/ijerph16214161.
PubMed 31661938Nashner LM, Shumway-Cook A, Marin O. Stance posture control in select groups of children with cerebral palsy: deficits in sensory organization and muscular coordination. Exp Brain Res. 1983;49(3):393-409. doi: 10.1007/BF00238781.
PubMed 6641837Chen CL, Shen IH, Chen CY, Wu CY, Liu WY, Chung CY. Validity, responsiveness, minimal detectable change, and minimal clinically important change of Pediatric Balance Scale in children with cerebral palsy. Res Dev Disabil. 2013 Mar;34(3):916-22. doi: 10.1016/j.ridd.2012.11.006. Epub 2013 Jan 3.
PubMed 23291508Ortega-Martinez A, Palomo-Carrion R, Varela-Ferro C, Bagur-Calafat MC. Feasibility of a Home-Based Mirror Therapy Program in Children with Unilateral Spastic Cerebral Palsy. Healthcare (Basel). 2023 Jun 19;11(12):1797. doi: 10.3390/healthcare11121797.
PubMed 37372915Brien M, Sveistrup H. An intensive virtual reality program improves functional balance and mobility of adolescents with cerebral palsy. Pediatr Phys Ther. 2011 Fall;23(3):258-66. doi: 10.1097/PEP.0b013e318227ca0f.
PubMed 21829120Kashif M, Ahmad A, Bandpei MAM, Gilani SA, Hanif A, Iram H. Combined effects of virtual reality techniques and motor imagery on balance, motor function and activities of daily living in patients with Parkinson's disease: a randomized controlled trial. BMC Geriatr. 2022 Apr 30;22(1):381. doi: 10.1186/s12877-022-03035-1.
PubMed 35488213Saleem GT. Defining and measuring motor imagery in children: mini review. Front Psychol. 2023 Aug 16;14:1227215. doi: 10.3389/fpsyg.2023.1227215. eCollection 2023.
PubMed 37655192Collet C, Guillot A, Lebon F, MacIntyre T, Moran A. Measuring motor imagery using psychometric, behavioral, and psychophysiological tools. Exerc Sport Sci Rev. 2011 Apr;39(2):85-92. doi: 10.1097/JES.0b013e31820ac5e0.
PubMed 21206282Steenbergen B, Craje C, Nilsen DM, Gordon AM. Motor imagery training in hemiplegic cerebral palsy: a potentially useful therapeutic tool for rehabilitation. Dev Med Child Neurol. 2009 Sep;51(9):690-6. doi: 10.1111/j.1469-8749.2009.03371.x.
PubMed 19709140Steenbergen B, Jongbloed-Pereboom M, Spruijt S, Gordon AM. Impaired motor planning and motor imagery in children with unilateral spastic cerebral palsy: challenges for the future of pediatric rehabilitation. Dev Med Child Neurol. 2013 Nov;55 Suppl 4:43-6. doi: 10.1111/dmcn.12306.
PubMed 24237279Souto DO, Cruz TKF, Fontes PLB, Haase VG. Motor imagery in children with unilateral cerebral palsy: a case-control study. Dev Med Child Neurol. 2020 Dec;62(12):1396-1405. doi: 10.1111/dmcn.14672. Epub 2020 Sep 29.
PubMed 32996138
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Versus Motor Imagery on Balance, Gross Motor Function and Activities of Daily Living in Children With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT06303440
- Acronym / sponsor ID
- REC/RCR&AHS/23/0288
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, Motor control, activities of daily living, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 12 Mar 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 neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Motor Imagery is an ability to engage in the mental representation of a task consciously without generating a voluntary movement. The aim of this study is to determine the comparative effects of Virtual Reality and Motor Imagery on balance, gross motor function and activities of daily living in children with cerebral palsy.
Detailed description
This randomized controlled trial will be conducted at Rising Sun Institute. The sample size calculated for this trial will be 75. The participants will be randomly allocated using online randomization tool into three groups; Group A will receive routine physical therapy (PT) for 30 minutes with additional selected exercises for 15 minutes, Group B will receive VR training for 15 minutes with routine PT for 30 minutes, and Group C will receive MI for 15 minutes and routine PT for 30 minutes. Each participant will receive treatment for three days on alternative days per week for 12 weeks. Gross Motor Function Scale (GMFCS) will be used for balance, Bruininks-Oseretsky Test of motor function Proficiency-2 (BOT-2 ) for motor function, and WeeFIM scale for ADLs at baseline, 8th week, 12th week, and at 16th week after discontinuation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Routine Physical Therapy+ Balance Training) | Other | Other: Routine Physical Therapy+ Balance TrainingThe children will be provided with Routine Physical Therapy and Balance Training. Balance exercises will be provided for 15 minutes and 30 minutes of Routine physical therapy will be as strengthening and stretching exercises. |
| Group B (Virtual Reality + Routine Physical Therapy) | Experimental | Other: Virtual Reality+ Routine Physical TherapyThe VR system consisted of a wall-mounted display, a Nintendo Wii box, a Wii remote, and a Wii Fit board. The participants will be instructed to stand on Wii Fit board while interacting with the VR system and playing the selected games and routine physical therapy of 30 minutes will be provided. |
| Group C (Motor Imagery+ Routine Physical Therapy) | Experimental | Other: Motor Imagery+ Routine Physical TherapyDuring the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children of 7-12 years of both genders, Children with Mini Mental Scale score >24.
- Children with Gross motor function classification system (GMFCS) level I and II and able to follow and accept verbal instruction.
- Exclusion Criteria: History of any Visual and Hearing Impairments, Virtual game phobia.
- History of nerve, muscle, bone and joint diseases that seriously affect the movement function of the limbs and Children with history of severe cardiopulmonary disease, History of epilepsy, History of Fixed deformity of Lower limb. History of orthopaedic surgery and botulinum toxin injection.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Routine Physical Therapy+ Balance TrainingEach session will be begun with routine PT treatment and lasted for 45 minutes in total. To start, the participants will be asked to do warm-up exercises, sitting comfortably on a chair with their backs and feet well supported, the participants will be instructed to breathe in and out. Warm-up exercises will be carried out for 5 minutes. Stretching exercises will be performed for 15 minutes per session, and stretches were held for 30 seconds with four repetitions of each of the following areas, shoulder flexors, elbow and wrist flexors, hip flexors, hip adductors, knee flexors, and calf, 10 seconds of rest period will be added after stretching of one muscle group. Participants will have a 15 minutes session of exercises neck holding on form roller for 1 minute with two repetitions, astride-sitting on foam roller for 2 minutes with four repetitions, weight on both hands on gym ball for 1 minute with two repetitions and hip adductors strengthening for 1 minute with three repetitions. | Other | Group A (Routine Physical Therapy+ Balance Training) |
| Virtual Reality+ Routine Physical TherapyThe exercises will be selected, and the difficulty level will be gradually increased according to participant's performance. Starting from the penguin slide, they will progress to table tilt. Initially, each game will be played for 2 minutes per session. With the progression of performance, 4 minutes of table tilt will be added. While playing this game, a typical mobility pattern will be initiated, and balance will be improved. In the same week, the subjects performed single-leg extensions for 1 minutes. In the following weeks, Balance Bubble, Advanced step, and Basic Run will be added to the plan. The participants will perform these activities for 7 minutes per session. Treatment sessions then progressed to motor function games, including bowling, tennis, kicking, and boxing (least challenging to most challenging), with most treatment sessions ending with boxing will be provided for 7 minutes and routine physical therapy for 30 minutes as explained in control group. | Other | Group B (Virtual Reality + Routine Physical Therapy) |
| Motor Imagery+ Routine Physical TherapyThe 15 minutes of Motor Imagery session will be provided to participants. It's a three step process that will be used to incorporate the technique. Step I, The self-recorded videos of the principal researcher performing a normal movements will be shown to participant. Step II, The participants will be asked to imagine movement with eyes closed, and breathe deeply. Step III The participants will be asked to perform the movement you watched in video and routine physical therapy of 30 minutes will be provided. During the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video. | Other | Group C (Motor Imagery+ Routine Physical Therapy) |
Primary outcome
Gross Motor Function Classification System
Time frame: 12 weeks
Gross Motor Function Classification System will be used to measure balance
Bruininks-Oseretsky Test of motor function Proficiency-2
Time frame: 12 Weeks
It will be measured with Bruininks-Oseretsky Test of motor function Proficiency-2 for motor function.
Functional Independence Measure for Children
Time frame: 12 Weeks
Functional Independence Measure for Children scale will be used to determine the Activities of Daily Living improvement.
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 28 Oct 2024.
- Background: PubMed 31661938Wu J, Loprinzi PD, Ren Z. The Rehabilitative Effects of Virtual Reality Games on Balance Performance among Children with Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2019 Oct 28;16(21):4161. doi: 10.3390/ijerph16214161.
- Background: PubMed 6641837Nashner LM, Shumway-Cook A, Marin O. Stance posture control in select groups of children with cerebral palsy: deficits in sensory organization and muscular coordination. Exp Brain Res. 1983;49(3):393-409. doi: 10.1007/BF00238781.
- Background: PubMed 23291508Chen CL, Shen IH, Chen CY, Wu CY, Liu WY, Chung CY. Validity, responsiveness, minimal detectable change, and minimal clinically important change of Pediatric Balance Scale in children with cerebral palsy. Res Dev Disabil. 2013 Mar;34(3):916-22. doi: 10.1016/j.ridd.2012.11.006. Epub 2013 Jan 3.
- Background: PubMed 37372915Ortega-Martinez A, Palomo-Carrion R, Varela-Ferro C, Bagur-Calafat MC. Feasibility of a Home-Based Mirror Therapy Program in Children with Unilateral Spastic Cerebral Palsy. Healthcare (Basel). 2023 Jun 19;11(12):1797. doi: 10.3390/healthcare11121797.
- Background: PubMed 21829120Brien M, Sveistrup H. An intensive virtual reality program improves functional balance and mobility of adolescents with cerebral palsy. Pediatr Phys Ther. 2011 Fall;23(3):258-66. doi: 10.1097/PEP.0b013e318227ca0f.
- Background: PubMed 35488213Kashif M, Ahmad A, Bandpei MAM, Gilani SA, Hanif A, Iram H. Combined effects of virtual reality techniques and motor imagery on balance, motor function and activities of daily living in patients with Parkinson's disease: a randomized controlled trial. BMC Geriatr. 2022 Apr 30;22(1):381. doi: 10.1186/s12877-022-03035-1.
- Background: PubMed 37655192Saleem GT. Defining and measuring motor imagery in children: mini review. Front Psychol. 2023 Aug 16;14:1227215. doi: 10.3389/fpsyg.2023.1227215. eCollection 2023.
- Background: PubMed 21206282Collet C, Guillot A, Lebon F, MacIntyre T, Moran A. Measuring motor imagery using psychometric, behavioral, and psychophysiological tools. Exerc Sport Sci Rev. 2011 Apr;39(2):85-92. doi: 10.1097/JES.0b013e31820ac5e0.
- Background: PubMed 19709140Steenbergen B, Craje C, Nilsen DM, Gordon AM. Motor imagery training in hemiplegic cerebral palsy: a potentially useful therapeutic tool for rehabilitation. Dev Med Child Neurol. 2009 Sep;51(9):690-6. doi: 10.1111/j.1469-8749.2009.03371.x.
- Background: PubMed 24237279Steenbergen B, Jongbloed-Pereboom M, Spruijt S, Gordon AM. Impaired motor planning and motor imagery in children with unilateral spastic cerebral palsy: challenges for the future of pediatric rehabilitation. Dev Med Child Neurol. 2013 Nov;55 Suppl 4:43-6. doi: 10.1111/dmcn.12306.
- Background: PubMed 32996138Souto DO, Cruz TKF, Fontes PLB, Haase VG. Motor imagery in children with unilateral cerebral palsy: a case-control study. Dev Med Child Neurol. 2020 Dec;62(12):1396-1405. doi: 10.1111/dmcn.14672. Epub 2020 Sep 29.
- 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.
Muhammad Kashif, PhD-PT study chair
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 Routine Physical Therapy+ Balance Training, Virtual Reality+ Routine Physical Therapy and Motor Imagery+ Routine Physical Therapy 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 0 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 28 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?
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?
Gross Motor Function Classification System (time frame: 12 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 NCT06303440, which also lists 11 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 28 Oct 2024.