Cerebral Palsy Spastic DiplegiaNCT05412485
Gait Improvement After Increased Frequency of Robot-assisted Gait Training in Cerebral Palsy Children
A study testing Robotic assisted gait training in people with Cerebral Palsy Spastic Diplegia, run by University of Sharjah at 1 site in United Arab Emirates.
Trial summary
Robot-assisted gait training (RAGT) can provide a longer training duration with a higher repetition of stepping while maintaining a stable pattern of movement. However, the existing evidence of its effectiveness is not clear. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- Robotic assisted gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 7 Jun 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with spastic diplegia; being able to walk independently with or without using walking aids on at least 10 meters; classified as level Ι, II and ΙΙΙ in the gross motor function classification system (GMFCS).
- Children who can follow instructions of gross motor function measure (GMFM) testing and able to express discomfort and pain by verbal or nonverbal signs, having required range for lokomat (hip and knee flexion contracture ≤10°, knee valgus ≤40°, femur length ≥ 23 cm).
Who cannot join
- If they received botulinum toxin injections or underwent surgical intervention at least a year before the 6-week of the intervention or participated in another Lokomat training regime within the last 3 months.
- If they have: (a) fixed contractures and/or with bone instability; (b) seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months); (c) baclofen infusion pumps in situ, open skin lesions and vascular disorder of lower extremities.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
University of Sharjah
University City, Emirate of Sharjah
Meeyoung Kim, PhD, +97165057367, mkim@sharjah.ac.ae
About this study
Official title: Does Increased Frequency of Robot-assisted Gait Training Improve Gait Functions and Quality of Gait in Children With Cerebral Palsy: A Single Blinded, Randomized Pilot Study
Robot-assisted gait training (RAGT) can provide a longer training duration with a higher repetition of stepping while maintaining a stable pattern of movement. However, the existing evidence of its effectiveness is not clear. The aim of this study is to investigate the feasibility and the effect of increased frequency (4 times per week) of RAGT compared to the most common frequency (2 times per week). we hypothesize that increased frequency of RAGT will result in greater improvements on the gait functions. This research will investigate the effect of increased frequency on robotic assisted gait training (RAGT) in a frequency of 4 times per a week, and will compare the effect of robotic assisted gait training (RAGT) with increased frequency and with usual frequency (2 times per a week) in regards with gait functional parameters such as balance, speed, endurance, and quality of gait among cerebral palsy (CP) children's.
Read the detailed description
Cerebral palsy (CP) is defined as a group of disorders that affect mobility and posture with heterogeneous impairments such as muscle tone alternation, reduced selective motor control, joint contracture, postural control impairment and weakness of muscles. Independent walking is a priority goal for a lot of parents and children with CP.
RAGT has been considered as a revolutionary technology for gait enhancement. Lokomat, as one of RAGT devices, provides the intensive gait training with a number of repetitions of stepping while it preserves consistent pattern of movement. Lokomat with additional virtual reality games adds fun and challenge and enhances the involvement and motivation throughout the whole session. We will use Lokomat for RAGT for 6 weeks phase for both treatement and control groups. Only difference between groups is the frequency: 4 times a week for treatment group and 2 times a week for intervention group.
General gait and standing function will be measured by Gross motor function measure dimension E and D. Speed, endurance, balance, and quality of gait would be measured by 10 meter walk test, 6 minutes walk test, pediatric balance scale, and Edinburgh visual gait score. To our knowledge no previous studies investigated the effect of the increased frequency in RAGT with lokomat on improving gait speed, endurance, balance and quality in children with CP.
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- Robotic assisted gait training
- Keywords
- Randomized pilot study, Cerebral palsy, Robotic assisted gait training, gait function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted gait trainingOther
Robotic assisted gait training is advanced technology used in the rehabilitation of neurological injuries and conditions like spinal cord injury, brain injury, stroke, multiple sclerosis, Parkinson's, cerebral palsy. It provides a repetitive task-specific motor training and modulates afferent input to spinal cord to generate rhythmic gait patterns that may be transformed to overground walking. The intensive repetitions of the rhythmic stepping movement during the training stimulates dependent plasticity and it may lead to brain reorganization. It facilitates cortical neural activities associated with motor control of walking.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Lokomat Certified physiotherapists will perform robotic assisted gait trainings. It will be performed 4 times per a week with a duration of 30 minutes on the lokomat with a treatment of 6 weeks phase.
Initially the Physical therapist will adjust the body -weight support at 70 % which will be gradually reduced until obtain flexion of the knees during stance phases. The lokomat certified physiotherapist will monitor the condition of the knees and adjust the body weight support during the training.
The Gait speed will be set at 0.7 km/hour and will gradually increase according to the comfortable speed selected by the child. The gait speed, Body weight support and the guidance force of the Lokomat will be adjusted and modified individually according to the ability of the child.
Virtual reality games will be used to motivate the participants and verbal encouragement will be used to increase their adherence to the intervention. Receives: Other: Robotic assisted gait training |
| Control group | Active comparator | The same procedures will be given twice a week frequency. Receives: Other: Robotic assisted gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Gross motor function measure - Dimension E (GMFM E) between pre-treatment and post-treatment
it evaluates 24 items which assess the ability of walking, running and jumping and 4 points ordinals scale (0 to 3) will be scored. A scoring key of 0 "does not initiate", 1 "initiates", 2 "partially completes", 3 "completed" is used. The score will be calculated into percentage. The possible score range is 0% to 100%. Higher percentage means better performance. An experienced physiotherapist in pediatric will instruct the children while video will be recorded.
Measured: will be measured at two intervals; pre-treatment and immediately after treatment
The change in Pediatric balance scale (PBS) between pre-treatment and post-treatment
PBS is an adapted tool from berg balance scale to assess balance for children diagnosed with cerebral palsy (CP) with mild to moderate motor dysfunction. The scale is consisting of 14 items including siting, standing and change of position. 5 points ordinals scale (0 to 4) will be given. 0 is poorest and 4 is the best performance for each items. The participant will have 3 trials and the best of three trials will be considered for the scoring. Possible range of total score is 0 to 56.
Measured: will be measured at two intervals; pre-treatment and immediately after treatment
The change in Six minutes' walk test (6MWT) between pre-treatment and post-treatment
6-miutes walk test will be performed to evaluate the endurance in 30-meter walkway with marked cones at each start and end point. It measures the distance a individual is able to walk over a total of six minutes in meter. The individual is allowed to self-pace and rest as needed as they traverse back an forth along a marked walkway.
Measured: will be measured at two intervals; pre-treatment and immediately after treatment
The change in Ten meter walk test (10MWT) between pre-treatment and post-treatment
10MWT will be used to evaluate the gait speed in meter per second which is performed on 14- meter track with the use of walking aid if the child is using during ambulation. The participant will perform 3 trials and average time will be used for the speed in meter per second.
Measured: will be measured at two intervals; pre-treatment and immediately after treatment
The change in Edinburg visual gait score (EVGS) between pre-treatment and post-treatment
EVGS assesses the gait quality and pattern by observation which can be used every day in practice in mobilizing children diagnosed with cerebral palsy when gait analysis instrument is not available. It's a tabulated system which can record 17 observational items for each lower extremity in which the selected items represent a feature of pathological gait of ambulatory children with cerebral palsy. Six anatomical level such as trunk , pelvis ,hip , knee and foot will be observed from recording video. Sagittal, coronal, and transverse planes will be assessed. The selected angle of the joint is calculated from data obtained during instrumented analysis gait of normal subject.
Measured: will be measured at two intervals; pre-treatment and immediately after treatment
Secondary outcomes (1)
The change in Gross motor function measure - Dimension D (GMFM D) between pre-treatment and post-treatment
it is consist of 13 items and will be used to evaluate the ability of standing. 4 points ordinals scale (0 to 3) will be scored. A scoring key of 0 "does not initiate", 1 "initiates", 2 "partially completes", 3 "completed" is used. The score will be calculated into percentage. The possible score range is 0% to 100%. Higher percentage means better performance. An experienced physiotherapist in pediatric will instruct the children while video will be recorded.
Measured: will be measured at two intervals; pre-treatment and immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start7 Jun 2022 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jul 2022 (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 Palsy Spastic DiplegiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective single blinded parallet-group, randomized clinical trial would be conducted.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meeyoung Kim, University of Sharjah
- Investigators
- Meeyoung Kim, PhD, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412485
- Sponsor's protocol ID
- REC-21-06-22-01-S
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make individual parrticipant data and related data dictionaries available.
Publications
Ammann-Reiffer C, Bastiaenen CH, Meyer-Heim AD, van Hedel HJ. Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT). BMC Pediatr. 2017 Mar 2;17(1):64. doi: 10.1186/s12887-017-0815-y.
PubMed 28253887Aurich-Schuler T, Warken B, Graser JV, Ulrich T, Borggraefe I, Heinen F, Meyer-Heim A, van Hedel HJ, Schroeder AS. Practical Recommendations for Robot-Assisted Treadmill Therapy (Lokomat) in Children with Cerebral Palsy: Indications, Goal Setting, and Clinical Implementation within the WHO-ICF Framework. Neuropediatrics. 2015 Aug;46(4):248-60. doi: 10.1055/s-0035-1550150. Epub 2015 May 26.
PubMed 26011438Hilderley AJ, Fehlings D, Lee GW, Wright FV. Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. Springerplus. 2016 Oct 28;5(1):1886. doi: 10.1186/s40064-016-3535-0. eCollection 2016.
PubMed 27843743Jin LH, Yang SS, Choi JY, Sohn MK. The Effect of Robot-Assisted Gait Training on Locomotor Function and Functional Capability for Daily Activities in Children with Cerebral Palsy: A Single-Blinded, Randomized Cross-Over Trial. Brain Sci. 2020 Oct 30;10(11):801. doi: 10.3390/brainsci10110801.
PubMed 33143214Lefmann S, Russo R, Hillier S. The effectiveness of robotic-assisted gait training for paediatric gait disorders: systematic review. J Neuroeng Rehabil. 2017 Jan 5;14(1):1. doi: 10.1186/s12984-016-0214-x.
PubMed 28057016
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Increased Frequency of Robot-assisted Gait Training Improve Gait Functions and Quality of Gait in Children With Cerebral Palsy: A Single Blinded, Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05412485
- Acronym / sponsor ID
- REC-21-06-22-01-S
- Conditions
- Cerebral Palsy Spastic Diplegia
- Keywords
- Randomized pilot study, Cerebral palsy, Robotic assisted gait training, gait function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 7 Jun 2022 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 9 Jun 2022 (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.
Robot-assisted gait training (RAGT) can provide a longer training duration with a higher repetition of stepping while maintaining a stable pattern of movement. However, the existing evidence of its effectiveness is not clear. The aim of this study is to investigate the feasibility and the effect of increased frequency (4 times per week) of RAGT compared to the most common frequency (2 times per week). we hypothesize that increased frequency of RAGT will result in greater improvements on the gait functions. This research will investigate the effect of increased frequency on robotic assisted gait training (RAGT) in a frequency of 4 times per a week, and will compare the effect of robotic assisted gait training (RAGT) with increased frequency and with usual frequency (2 times per a week) in regards with gait functional parameters such as balance, speed, endurance, and quality of gait among cerebral palsy (CP) children's.
Detailed description
Cerebral palsy (CP) is defined as a group of disorders that affect mobility and posture with heterogeneous impairments such as muscle tone alternation, reduced selective motor control, joint contracture, postural control impairment and weakness of muscles. Independent walking is a priority goal for a lot of parents and children with CP.
RAGT has been considered as a revolutionary technology for gait enhancement. Lokomat, as one of RAGT devices, provides the intensive gait training with a number of repetitions of stepping while it preserves consistent pattern of movement. Lokomat with additional virtual reality games adds fun and challenge and enhances the involvement and motivation throughout the whole session. We will use Lokomat for RAGT for 6 weeks phase for both treatement and control groups. Only difference between groups is the frequency: 4 times a week for treatment group and 2 times a week for intervention group.
General gait and standing function will be measured by Gross motor function measure dimension E and D. Speed, endurance, balance, and quality of gait would be measured by 10 meter walk test, 6 minutes walk test, pediatric balance scale, and Edinburgh visual gait score. To our knowledge no previous studies investigated the effect of the increased frequency in RAGT with lokomat on improving gait speed, endurance, balance and quality in children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective single blinded parallet-group, randomized clinical trial would be conducted.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Robotic assisted gait trainingLokomat Certified physiotherapists will perform robotic assisted gait trainings. It will be performed 4 times per a week with a duration of 30 minutes on the lokomat with a treatment of 6 weeks phase. Initially the Physical therapist will adjust the body -weight support at 70 % which will be gradually reduced until obtain flexion of the knees during stance phases. The lokomat certified physiotherapist will monitor the condition of the knees and adjust the body weight support during the training. The Gait speed will be set at 0.7 km/hour and will gradually increase according to the comfortable speed selected by the child. The gait speed, Body weight support and the guidance force of the Lokomat will be adjusted and modified individually according to the ability of the child. Virtual reality games will be used to motivate the participants and verbal encouragement will be used to increase their adherence to the intervention. |
| Control group | Active comparator | Other: Robotic assisted gait trainingThe same procedures will be given twice a week frequency. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children with spastic diplegia; being able to walk independently with or without using walking aids on at least 10 meters; classified as level Ι, II and ΙΙΙ in the gross motor function classification system (GMFCS).
- Children who can follow instructions of gross motor function measure (GMFM) testing and able to express discomfort and pain by verbal or nonverbal signs, having required range for lokomat (hip and knee flexion contracture ≤10°, knee valgus ≤40°, femur length ≥ 23 cm).
Key exclusion criteria (2 listed)
- If they received botulinum toxin injections or underwent surgical intervention at least a year before the 6-week of the intervention or participated in another Lokomat training regime within the last 3 months.
- If they have: (a) fixed contractures and/or with bone instability; (b) seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months); (c) baclofen infusion pumps in situ, open skin lesions and vascular disorder of lower extremities.
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 |
|---|---|---|
| Robotic assisted gait trainingRobotic assisted gait training is advanced technology used in the rehabilitation of neurological injuries and conditions like spinal cord injury, brain injury, stroke, multiple sclerosis, Parkinson's, cerebral palsy. It provides a repetitive task-specific motor training and modulates afferent input to spinal cord to generate rhythmic gait patterns that may be transformed to overground walking. The intensive repetitions of the rhythmic stepping movement during the training stimulates dependent plasticity and it may lead to brain reorganization. It facilitates cortical neural activities associated with motor control of walking. | Other | Control group, Treatment group |
Primary outcome
The change in Gross motor function measure - Dimension E (GMFM E) between pre-treatment and post-treatment
Time frame: will be measured at two intervals; pre-treatment and immediately after treatment
it evaluates 24 items which assess the ability of walking, running and jumping and 4 points ordinals scale (0 to 3) will be scored. A scoring key of 0 "does not initiate", 1 "initiates", 2 "partially completes", 3 "completed" is used. The score will be calculated into percentage. The possible score range is 0% to 100%. Higher percentage means better performance. An experienced physiotherapist in pediatric will instruct the children while video will be recorded.
The change in Pediatric balance scale (PBS) between pre-treatment and post-treatment
Time frame: will be measured at two intervals; pre-treatment and immediately after treatment
PBS is an adapted tool from berg balance scale to assess balance for children diagnosed with cerebral palsy (CP) with mild to moderate motor dysfunction. The scale is consisting of 14 items including siting, standing and change of position. 5 points ordinals scale (0 to 4) will be given. 0 is poorest and 4 is the best performance for each items. The participant will have 3 trials and the best of three trials will be considered for the scoring. Possible range of total score is 0 to 56.
The change in Six minutes' walk test (6MWT) between pre-treatment and post-treatment
Time frame: will be measured at two intervals; pre-treatment and immediately after treatment
6-miutes walk test will be performed to evaluate the endurance in 30-meter walkway with marked cones at each start and end point. It measures the distance a individual is able to walk over a total of six minutes in meter. The individual is allowed to self-pace and rest as needed as they traverse back an forth along a marked walkway.
The change in Ten meter walk test (10MWT) between pre-treatment and post-treatment
Time frame: will be measured at two intervals; pre-treatment and immediately after treatment
10MWT will be used to evaluate the gait speed in meter per second which is performed on 14- meter track with the use of walking aid if the child is using during ambulation. The participant will perform 3 trials and average time will be used for the speed in meter per second.
The change in Edinburg visual gait score (EVGS) between pre-treatment and post-treatment
Time frame: will be measured at two intervals; pre-treatment and immediately after treatment
EVGS assesses the gait quality and pattern by observation which can be used every day in practice in mobilizing children diagnosed with cerebral palsy when gait analysis instrument is not available. It's a tabulated system which can record 17 observational items for each lower extremity in which the selected items represent a feature of pathological gait of ambulatory children with cerebral palsy. Six anatomical level such as trunk , pelvis ,hip , knee and foot will be observed from recording video. Sagittal, coronal, and transverse planes will be assessed. The selected angle of the joint is calculated from data obtained during instrumented analysis gait of normal subject.
1 secondary outcome
The change in Gross motor function measure - Dimension D (GMFM D) between pre-treatment and post-treatment
Time frame: will be measured at two intervals; pre-treatment and immediately after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Background: PubMed 28253887Ammann-Reiffer C, Bastiaenen CH, Meyer-Heim AD, van Hedel HJ. Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT). BMC Pediatr. 2017 Mar 2;17(1):64. doi: 10.1186/s12887-017-0815-y.
- Background: PubMed 26011438Aurich-Schuler T, Warken B, Graser JV, Ulrich T, Borggraefe I, Heinen F, Meyer-Heim A, van Hedel HJ, Schroeder AS. Practical Recommendations for Robot-Assisted Treadmill Therapy (Lokomat) in Children with Cerebral Palsy: Indications, Goal Setting, and Clinical Implementation within the WHO-ICF Framework. Neuropediatrics. 2015 Aug;46(4):248-60. doi: 10.1055/s-0035-1550150. Epub 2015 May 26.
- Background: PubMed 27843743Hilderley AJ, Fehlings D, Lee GW, Wright FV. Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. Springerplus. 2016 Oct 28;5(1):1886. doi: 10.1186/s40064-016-3535-0. eCollection 2016.
- Background: PubMed 33143214Jin LH, Yang SS, Choi JY, Sohn MK. The Effect of Robot-Assisted Gait Training on Locomotor Function and Functional Capability for Daily Activities in Children with Cerebral Palsy: A Single-Blinded, Randomized Cross-Over Trial. Brain Sci. 2020 Oct 30;10(11):801. doi: 10.3390/brainsci10110801.
- Background: PubMed 28057016Lefmann S, Russo R, Hillier S. The effectiveness of robotic-assisted gait training for paediatric gait disorders: systematic review. J Neuroeng Rehabil. 2017 Jan 5;14(1):1. doi: 10.1186/s12984-016-0214-x.
- Individual participant dataSharing planned: Yes. There is a plan to make individual parrticipant data and related data dictionaries available.
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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.
Meeyoung Kim, PhD principal investigator
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic assisted gait training in people with Cerebral Palsy Spastic Diplegia, run by University of Sharjah at 1 site in United Arab Emirates.
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 2 inclusion and 2 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 9 Jun 2022. 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 United Arab Emirates. 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?
Contact Meeyoung Kim, PhD (+97165057367, mkim@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Gross motor function measure - Dimension E (GMFM E) between pre-treatment and post-treatment (time frame: will be measured at two intervals; pre-treatment and immediately after treatment). The study lists 5 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 NCT05412485, 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 9 Jun 2022.