Cerebral Palsy Spastic DiplegiaNCT04467385
Virtual Reality Training With Sensory Integration On The Gross Motor Functions Of Lower Limb
A study testing VR training + Sensory Integration therapy + conventional therapy and VR training + conventional therapy in people with Cerebral Palsy Spastic Diplegia, run by Riphah International University at 1 site in Pakistan.
Trial summary
The objectives of this study are To determine the effect of virtual reality on balance and gross motor functions of the lower limb in spastic diplegic cerebral palsy. To determine the effect of virtual reality with sensory input on balance and gross motor functions of the lower limb in spastic diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- VR training + Sensory Integration therapy + conventional therapy and VR training + conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2019to 15 Jan 2020
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diplegic CP children aged 5-12 years
- Gross motor function classification system System (GMFCS) I - II
- Children can be independent Walking distance >5 meters
- Spasticity of lower limb < 3 ..
- A child able to understand command and can play VR games.
Who cannot join
- Any Bone and joint diseases
- Epilepsy
- Mental illness
- Mental retardation etc. cannot be matched with the completion of the experiment.
- Any history of taking anticonvulsant drugs or muscle relaxants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Virtual Reality Training With Sensory Integration On The Gross Motor Functions Of Lower Limb In Spastic Diplegic Cerebral Palsy.
The objectives of this study are To determine the effect of virtual reality on balance and gross motor functions of the lower limb in spastic diplegic cerebral palsy. To determine the effect of virtual reality with sensory input on balance and gross motor functions of the lower limb in spastic diplegic cerebral palsy. To compare the effects of virtual reality training with and without sensory input on balance and gross motor functions of the lower limb in spastic diplegic CP. Its is a Randomized control trial (RCT) done at Physiotherapy department of Railway General Hospital Rawalpindi and National Institute of rehabilitation Medicine.44 individuals (calculated using epi tool) 22 individuals in each group. Individuals who met the inclusion criteria will be included in this study. All participants will go through randomization and divided into two groups Experimental and Control groups. Pre-intervention assessment is made for both groups. Then intervention will be applied to both groups. estimated time of treatment protocol will be 40 min/day, 1 time / d, 3 times/week for 6 weeks. Subjects will be evaluated at baseline, then 3rd week and 6th-week assessment will be the final
Read the detailed description
Cerebral Palsy(CP) is a common non-progressive disorder that occurs due to any injury or aberration to the developing central nervous system. It refers to the disorders that stem from primary brain lesion leading to musculoskeletal and nervous abnormalities in the pediatric population. Cerebral palsy has a global incidence of 1-3.5 cases per 1000 live births. The most prevalent type is spastic diplegia which occurs in 30-40% of spastic cerebral palsy. According to motor impairment, it is classified into spastic, dyskinetic and ataxic cerebral palsy. The children with cerebral palsy have very poor control of voluntary muscle activity. Therefore training of selective motor control in children with cerebral palsy is an important part of physiotherapy intervention. Children are often not amenable to the conventional exercise program but studies have demonstrated that children show high interest and stimulation to virtual reality training. Virtual reality is a virtual environment system that enables a person to witness situations and actions similar to real-life. Therapists use Virtual reality systems to create a fascinating environment to gain targeted therapeutic goals. Sensory integration, on the other hand, is a therapeutic approach that involves active therapy and activities involving graded sensory experiences. It provides keen proprioceptive and tactile experiences. Sensory integration therapy usually involves balls, rolls, hammock, trampolines and altering surfaces. Children with spastic diplegia have gross and fine motor, sensory, cognitive impairments. This results in reduced ability to adjust the body and balance it with movements. Postural control demands active sensorimotor control. Exercise with mini-trampoline is designed for balance training to improve static and dynamic balance and postural adjustment in children with spastic diplegia. According to a study in 2016, Virtual reality training can effectively improve the gross motor function of the lower limbs in children with spastic diplegia in comparison to conventional therapy. As claimed by a study in, 2006 VR training in combination with conventional exercise therapy in spastic CP improves exercise compliance and enhance exercise effectiveness. It is a simple and executable approach which can be used by any skilled therapist as an independent treatment method to improve the outcome.
According to a study, sensory integration therapy had a measurable effect in children with spastic diplegic cerebral palsy who suffer from a sensory-motor deficit. A study observed the effects of sensory integration therapy in children with cerebral palsy and concluded that sensory integration therapy has a positive effect on gross motor function in spastic diplegic CP in sitting and standing positions. Whereas, the control group with only home exercise program showed no significant improvement.In 2018 compared the effects of rebound exercises and simple balance training on balance of spastic diplegic children. The assessments suggested that balance was improved in both groups but the group under study showed a significant difference and concluded that rebound exercises improve the balance and postural control. The past research records are evident that therapists have worked with either Virtual reality training or Sensory integration therapy for the rehabilitation of Spastic Diplegic children. The two protocols have not been complimented for rehabilitation. So the aim of this study is to observe and determine the combined effect of these two treatment protocols to get the results and improve the gross motor function in lower limbs of CP children.
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- VR training + Sensory Integration therapy + conventional therapy, VR training + conventional therapy
- Keywords
- Virtual Reality, Spastic Diplegic Cerebral Palsy, Sensory Integration
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR training + Sensory Integration therapy + conventional therapyOther
After the baseline assessment,
- Coconut ShootersVR - 5 min/day
- Ninja flipVR - 5 min/day.
- Sensory integration training include Exercises on BOSU ball and mini-trampoline. It will involve:
- Passive bouncing with child standing with his/her feet shoulder width apart for 2.5 and 2.5 minutes on both.
- Active bouncing (the child bounces and therapist will control the rate) for 2.5 and 2.5 minutes on both.
- Mini-squat exercises with feet apart and feet together for 2.5 and 2.5 minutes on both.
- Conventional exercises include:
- passive stretching exercises for the hip flexors, hip adductors, hamstring, and calf muscle; stretching will be applied for 30 sec with 30 sec rest for each muscle group within pain limit.
- Strengthening of abdominal and back muscles, hip abductions and knee joint extensors and ankle dorsiflexors will be performed.
VR training + conventional therapyOther
After the baseline assessment,
- The Your Shape: Fitness Evolved 2012TM game is selected for VR training (walking and walking with obstacles) for 8 min
- Coconut ShootersVR - 8 min/day
- Ninja flipVR - 8 min/day
- Conventional Therapy - 20 min per day
- Passive stretching exercises for the hip flexors, hip adductors, hamstring, and calf muscle; stretching will be applied for 30 sec with 30 sec rest 3-5 times for each muscle group within pain limit.
- Strengthening of abdominal and back muscles, hip abductions and knee joint extensors and ankle dorsiflexors will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Virtual Reality training(VR) + Sensory Integration therapy + conventional therapy Receives: Other: VR training + Sensory Integration therapy + conventional therapy |
| Control Group | Experimental | VR training + conventional therapy Receives: Other: VR training + conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale (PBS):
Pediatric Balance Scale (PBS) is a modification of Berg Balance Scale was developed as a balance measure for children with mild to moderate motor impairments.
Measured: Changes from baseline to 6th month
Gross Motor Function Measure (GMFM-88)
Its an 88-item tool for assessing and measuring changes in gross motor function in children with cerebral palsy. It's a four pint scale from 0-3 that indicates the grading of a specified task and the tool is further divided into five categories.
Measured: Changes from baseline to 6th month
2 min walk Test (2MWT)
The Two/2 Minute Walk Test (2 MWT) is a measure of self-paced walking ability and functional capacity. The 2 MWT is a simple measure of the distance a person can walk in two minutes. Rest breaks are allowed if needed. The person is encouraged to walk as fast as they can, safely, for two minutes. Walking aids can be used as needed.
Measured: Changes from baseline to 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start15 Jun 2019
- Primary completion15 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy Spastic DiplegiaStudies 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
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467385
- Sponsor's protocol ID
- REC/00557 Sannia Batool
- Status last verified
- Jul 2020
- First submitted
- 18 Mar 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bumin G, Kayihan H. Effectiveness of two different sensory-integration programmes for children with spastic diplegic cerebral palsy. Disabil Rehabil. 2001 Jun 15;23(9):394-9. doi: 10.1080/09638280010008843.
PubMed 11394590Lazzari RD, Politti F, Santos CA, Dumont AJ, Rezende FL, Grecco LA, Braun Ferreira LA, Oliveira CS. Effect of a single session of transcranial direct-current stimulation combined with virtual reality training on the balance of children with cerebral palsy: a randomized, controlled, double-blind trial. J Phys Ther Sci. 2015 Mar;27(3):763-8. doi: 10.1589/jpts.27.763. Epub 2015 Mar 31.
PubMed 25931726Bulekbayeva S, Daribayev Z, Ospanova S, Vento S. Cerebral palsy: a multidisciplinary, integrated approach is essential. Lancet Glob Health. 2017 Apr;5(4):e401. doi: 10.1016/S2214-109X(17)30082-7. No abstract available.
PubMed 28288745Bryanton C, Bosse J, Brien M, McLean J, McCormick A, Sveistrup H. Feasibility, motivation, and selective motor control: virtual reality compared to conventional home exercise in children with cerebral palsy. Cyberpsychol Behav. 2006 Apr;9(2):123-8. doi: 10.1089/cpb.2006.9.123.
PubMed 16640463Snider L, Majnemer A, Darsaklis V. Virtual reality as a therapeutic modality for children with cerebral palsy. Dev Neurorehabil. 2010;13(2):120-8. doi: 10.3109/17518420903357753.
PubMed 20222773Galli M, Cimolin V, Pau M, Leban B, Brunner R, Albertini G. Foot pressure distribution in children with cerebral palsy while standing. Res Dev Disabil. 2015 Jun-Jul;41-42:52-7. doi: 10.1016/j.ridd.2015.05.006. Epub 2015 Jun 6.
PubMed 26057837Ren K, Gong XM, Zhang R, Chen XH. [Effects of virtual reality training on limb movement in children with spastic diplegia cerebral palsy]. Zhongguo Dang Dai Er Ke Za Zhi. 2016 Oct;18(10):975-979. doi: 10.7499/j.issn.1008-8830.2016.10.011. Chinese.
PubMed 27751214
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Virtual Reality Training With Sensory Integration On The Gross Motor Functions Of Lower Limb In Spastic Diplegic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT04467385
- Acronym / sponsor ID
- REC/00557 Sannia Batool
- Conditions
- Cerebral Palsy Spastic Diplegia
- Keywords
- Virtual Reality, Spastic Diplegic Cerebral Palsy, Sensory Integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 13 Jul 2020 (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.
The objectives of this study are To determine the effect of virtual reality on balance and gross motor functions of the lower limb in spastic diplegic cerebral palsy. To determine the effect of virtual reality with sensory input on balance and gross motor functions of the lower limb in spastic diplegic cerebral palsy. To compare the effects of virtual reality training with and without sensory input on balance and gross motor functions of the lower limb in spastic diplegic CP. Its is a Randomized control trial (RCT) done at Physiotherapy department of Railway General Hospital Rawalpindi and National Institute of rehabilitation Medicine.44 individuals (calculated using epi tool) 22 individuals in each group. Individuals who met the inclusion criteria will be included in this study. All participants will go through randomization and divided into two groups Experimental and Control groups. Pre-intervention assessment is made for both groups. Then intervention will be applied to both groups. estimated time of treatment protocol will be 40 min/day, 1 time / d, 3 times/week for 6 weeks. Subjects will be evaluated at baseline, then 3rd week and 6th-week assessment will be the final
Detailed description
Cerebral Palsy(CP) is a common non-progressive disorder that occurs due to any injury or aberration to the developing central nervous system. It refers to the disorders that stem from primary brain lesion leading to musculoskeletal and nervous abnormalities in the pediatric population. Cerebral palsy has a global incidence of 1-3.5 cases per 1000 live births. The most prevalent type is spastic diplegia which occurs in 30-40% of spastic cerebral palsy. According to motor impairment, it is classified into spastic, dyskinetic and ataxic cerebral palsy. The children with cerebral palsy have very poor control of voluntary muscle activity. Therefore training of selective motor control in children with cerebral palsy is an important part of physiotherapy intervention. Children are often not amenable to the conventional exercise program but studies have demonstrated that children show high interest and stimulation to virtual reality training. Virtual reality is a virtual environment system that enables a person to witness situations and actions similar to real-life. Therapists use Virtual reality systems to create a fascinating environment to gain targeted therapeutic goals. Sensory integration, on the other hand, is a therapeutic approach that involves active therapy and activities involving graded sensory experiences. It provides keen proprioceptive and tactile experiences. Sensory integration therapy usually involves balls, rolls, hammock, trampolines and altering surfaces. Children with spastic diplegia have gross and fine motor, sensory, cognitive impairments. This results in reduced ability to adjust the body and balance it with movements. Postural control demands active sensorimotor control. Exercise with mini-trampoline is designed for balance training to improve static and dynamic balance and postural adjustment in children with spastic diplegia. According to a study in 2016, Virtual reality training can effectively improve the gross motor function of the lower limbs in children with spastic diplegia in comparison to conventional therapy. As claimed by a study in, 2006 VR training in combination with conventional exercise therapy in spastic CP improves exercise compliance and enhance exercise effectiveness. It is a simple and executable approach which can be used by any skilled therapist as an independent treatment method to improve the outcome.
According to a study, sensory integration therapy had a measurable effect in children with spastic diplegic cerebral palsy who suffer from a sensory-motor deficit. A study observed the effects of sensory integration therapy in children with cerebral palsy and concluded that sensory integration therapy has a positive effect on gross motor function in spastic diplegic CP in sitting and standing positions. Whereas, the control group with only home exercise program showed no significant improvement.In 2018 compared the effects of rebound exercises and simple balance training on balance of spastic diplegic children. The assessments suggested that balance was improved in both groups but the group under study showed a significant difference and concluded that rebound exercises improve the balance and postural control. The past research records are evident that therapists have worked with either Virtual reality training or Sensory integration therapy for the rehabilitation of Spastic Diplegic children. The two protocols have not been complimented for rehabilitation. So the aim of this study is to observe and determine the combined effect of these two treatment protocols to get the results and improve the gross motor function in lower limbs of CP children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: VR training + Sensory Integration therapy + conventional therapyVirtual Reality training(VR) + Sensory Integration therapy + conventional therapy |
| Control Group | Experimental | Other: VR training + conventional therapyVR training + conventional therapy |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diplegic CP children aged 5-12 years
- Gross motor function classification system System (GMFCS) I - II
- Children can be independent Walking distance >5 meters
- Spasticity of lower limb < 3 ..
- A child able to understand command and can play VR games.
Key exclusion criteria (5 listed)
- Any Bone and joint diseases
- Epilepsy
- Mental illness
- Mental retardation etc. cannot be matched with the completion of the experiment.
- Any history of taking anticonvulsant drugs or muscle relaxants.
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 |
|---|---|---|
| VR training + Sensory Integration therapy + conventional therapyAfter the baseline assessment, * Coconut ShootersVR - 5 min/day * Ninja flipVR - 5 min/day. * Sensory integration training include Exercises on BOSU ball and mini-trampoline. It will involve: * Passive bouncing with child standing with his/her feet shoulder width apart for 2.5 and 2.5 minutes on both. * Active bouncing (the child bounces and therapist will control the rate) for 2.5 and 2.5 minutes on both. * Mini-squat exercises with feet apart and feet together for 2.5 and 2.5 minutes on both. * Conventional exercises include: * passive stretching exercises for the hip flexors, hip adductors, hamstring, and calf muscle; stretching will be applied for 30 sec with 30 sec rest for each muscle group within pain limit. * Strengthening of abdominal and back muscles, hip abductions and knee joint extensors and ankle dorsiflexors will be performed. | Other | Experimental Group |
| VR training + conventional therapyAfter the baseline assessment, * The Your Shape: Fitness Evolved 2012TM game is selected for VR training (walking and walking with obstacles) for 8 min * Coconut ShootersVR - 8 min/day * Ninja flipVR - 8 min/day * Conventional Therapy - 20 min per day * Passive stretching exercises for the hip flexors, hip adductors, hamstring, and calf muscle; stretching will be applied for 30 sec with 30 sec rest 3-5 times for each muscle group within pain limit. * Strengthening of abdominal and back muscles, hip abductions and knee joint extensors and ankle dorsiflexors will be performed. | Other | Control Group |
Primary outcome
Pediatric Balance Scale (PBS):
Time frame: Changes from baseline to 6th month
Pediatric Balance Scale (PBS) is a modification of Berg Balance Scale was developed as a balance measure for children with mild to moderate motor impairments.
Gross Motor Function Measure (GMFM-88)
Time frame: Changes from baseline to 6th month
Its an 88-item tool for assessing and measuring changes in gross motor function in children with cerebral palsy. It's a four pint scale from 0-3 that indicates the grading of a specified task and the tool is further divided into five categories.
2 min walk Test (2MWT)
Time frame: Changes from baseline to 6th month
The Two/2 Minute Walk Test (2 MWT) is a measure of self-paced walking ability and functional capacity. The 2 MWT is a simple measure of the distance a person can walk in two minutes. Rest breaks are allowed if needed. The person is encouraged to walk as fast as they can, safely, for two minutes. Walking aids can be used as needed.
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 13 Jul 2020.
- Background: PubMed 11394590Bumin G, Kayihan H. Effectiveness of two different sensory-integration programmes for children with spastic diplegic cerebral palsy. Disabil Rehabil. 2001 Jun 15;23(9):394-9. doi: 10.1080/09638280010008843.
- Background: PubMed 25931726Lazzari RD, Politti F, Santos CA, Dumont AJ, Rezende FL, Grecco LA, Braun Ferreira LA, Oliveira CS. Effect of a single session of transcranial direct-current stimulation combined with virtual reality training on the balance of children with cerebral palsy: a randomized, controlled, double-blind trial. J Phys Ther Sci. 2015 Mar;27(3):763-8. doi: 10.1589/jpts.27.763. Epub 2015 Mar 31.
- Background: PubMed 28288745Bulekbayeva S, Daribayev Z, Ospanova S, Vento S. Cerebral palsy: a multidisciplinary, integrated approach is essential. Lancet Glob Health. 2017 Apr;5(4):e401. doi: 10.1016/S2214-109X(17)30082-7. No abstract available.
- Background: PubMed 16640463Bryanton C, Bosse J, Brien M, McLean J, McCormick A, Sveistrup H. Feasibility, motivation, and selective motor control: virtual reality compared to conventional home exercise in children with cerebral palsy. Cyberpsychol Behav. 2006 Apr;9(2):123-8. doi: 10.1089/cpb.2006.9.123.
- Background: PubMed 20222773Snider L, Majnemer A, Darsaklis V. Virtual reality as a therapeutic modality for children with cerebral palsy. Dev Neurorehabil. 2010;13(2):120-8. doi: 10.3109/17518420903357753.
- Background: PubMed 26057837Galli M, Cimolin V, Pau M, Leban B, Brunner R, Albertini G. Foot pressure distribution in children with cerebral palsy while standing. Res Dev Disabil. 2015 Jun-Jul;41-42:52-7. doi: 10.1016/j.ridd.2015.05.006. Epub 2015 Jun 6.
- Background: PubMed 27751214Ren K, Gong XM, Zhang R, Chen XH. [Effects of virtual reality training on limb movement in children with spastic diplegia cerebral palsy]. Zhongguo Dang Dai Er Ke Za Zhi. 2016 Oct;18(10):975-979. doi: 10.7499/j.issn.1008-8830.2016.10.011. Chinese.
- 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.
Aruba Saeed, PHD* 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 VR training + Sensory Integration therapy + conventional therapy and VR training + conventional therapy in people with Cerebral Palsy Spastic Diplegia, 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 5 inclusion and 5 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 13 Jul 2020. 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 (PBS): (time frame: Changes from baseline to 6th month). 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 NCT04467385, which also lists 7 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 13 Jul 2020.