Cerebral PalsyNCT06368180
The Efficacy of a RAGT & BWSTT on Children With CP
A study testing Robotic assisted gait training and Body weight supported treadmill training in people with Cerebral Palsy, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
This study compared the effects of Robotic-assisted Gait Training (RAGT) and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral Cerebral Palsy (CP) Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Robotic assisted gait training and Body weight supported treadmill training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Aug 2020to 8 Mar 2021
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged from 5 to 14 years with bilateral spastic Cerebral palsy (CP) diagnosed by a pediatrician.
- Gross Motor Function Classifications (GMFCS); levels I (walks without limitation), II (walks with limitation), and III (walks using assistive devices).
- Able to follow instructions and accurately signal pain and discomfort.
- Hip and knee passive Range of Motion (ROM) within the minimum range requirement for Robotic-assisted Gait Training (RAGT) (≤ 10⁰ for hip and knee flexion contracture and ≤ 40⁰ for knee valgus).
Who cannot join
- Botox injection for lower limb within the past 4 to 6 months.
- Surgical intervention for lower limbs within an 8-month period before the examination date, including tendon release and muscle lengthening in a 1-year period prior to bone surgery.
- Children using an active drug for resisting epilepsy.
- Anatomical leg length difference greater than 2 centimeters (due to the limitations of the RAGT system).
- Bone-articular instability (joint dislocation).
- Fixed joint contractures (bone and joint deformity).
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- Baclofen therapy with the use of an implanted infusion pump.
- Inhibited cast for a lower limb within 6 months of the study.
- Significant amblyopia and hearing loss.
- Skin inflammation and open skin lesion around the limb or trunk.
- Significant impairments in endurance due to a limitation in the cardiovascular system based on the patient's history.
- Maximum child weight is 135 kilograms and maximum height is 2.0 meters.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of a Robotic-assisted Gait Training in Comparison to Body Weight Supported Treadmill Training on Spatio-temporal Gait Parameters Among Ambulatory Children With Cerebral Palsy
This study compared the effects of Robotic-assisted Gait Training (RAGT) and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral Cerebral Palsy (CP)
Read the detailed description
Demographic data were collected from patient medical records in the physiotherapy clinic at King Abdullah Specialist Children's Hospital and by completing the screening sheet . There were two intervention groups in this study. The first group received Robotic-assisted Gait Training (RAGT), while the second group received body weight support treadmill training (BWSTT). All participants from both intervention groups performed the home exercise program. All participants received 24 sessions three times per week over 8 weeks. Some participants were absent from some treatment sessions, either because they were suffering from flu, for reasons related to school, or other reasons. These participants were compensated with other sessions. Outcome measurements were assessed by a physiotherapist blinded to the group allocations. A physiotherapist assessed the participants at baseline and after treatment (at the end of 8 weeks)
- Conditions
- Cerebral Palsy
- Being tested
- Robotic assisted gait training, Body weight supported treadmill training
- Keywords
- Children, Cerebral palsy, Robotic-assisted gait training, Body weight-supported treadmill training, Spatio-temporal gait parameters
- 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 trainingDevice
is a robotic treadmill training system that uses body weight support to suspend patients by attaching their legs to robotic legs that help them walk
Body weight supported treadmill trainingDevice
The Biodex Unweighting System was used to support the child's body weight, by an adjustable harness placed, over the treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted gait training group | Experimental | This group had gait training using a robotic treadmill training system that uses body weight support belt, and driven gait orthoses (pediatric orthoses) for both legs. Receives: Device: Robotic assisted gait training |
| Body weight support treadmill training group | Active comparator | This group had gait training using while the participant's body weight was supported over the treadmill by the Biodex Unweighting System. Receives: Device: Body weight supported treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait spatio-temporal parameters
The Zebris gait analysis system was used in this study to obtain gait spatio-temporal parameters in children with CP. The Zebris gait analysis system consists of a platform that has a sensing area of 200 × 60 cm.
Measured: 1 minute
Secondary outcomes (1)
Six-minute walk test (6MWT)
The 6MWT is a standardized walking test used to assess walking capacity in ambulatory children with CP. It is valid and reliable for children and adolescents who have CP and are healthy
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start30 Aug 2020
- Primary completion21 Feb 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Robotic-assisted gait training Body weight-supported treadmill training
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaber Mohammed Ali Fagehi, King Saud University
- Investigators
- Adel A Alhusaini, professor, Principal investigator, Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368180
- Sponsor's protocol ID
- 439106274
- Status last verified
- May 2024
- First submitted
- 11 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Robotic-assisted Gait Training in Comparison to Body Weight Supported Treadmill Training on Spatio-temporal Gait Parameters Among Ambulatory Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06368180
- Acronym / sponsor ID
- 439106274
- Conditions
- Cerebral Palsy
- Keywords
- Children, Cerebral palsy, Robotic-assisted gait training, Body weight-supported treadmill training, Spatio-temporal gait parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 16 Apr 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.
This study compared the effects of Robotic-assisted Gait Training (RAGT) and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral Cerebral Palsy (CP)
Detailed description
Demographic data were collected from patient medical records in the physiotherapy clinic at King Abdullah Specialist Children's Hospital and by completing the screening sheet . There were two intervention groups in this study. The first group received Robotic-assisted Gait Training (RAGT), while the second group received body weight support treadmill training (BWSTT). All participants from both intervention groups performed the home exercise program. All participants received 24 sessions three times per week over 8 weeks. Some participants were absent from some treatment sessions, either because they were suffering from flu, for reasons related to school, or other reasons. These participants were compensated with other sessions. Outcome measurements were assessed by a physiotherapist blinded to the group allocations. A physiotherapist assessed the participants at baseline and after treatment (at the end of 8 weeks)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Robotic-assisted gait training Body weight-supported treadmill training
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted gait training group | Experimental | Device: Robotic assisted gait trainingThis group had gait training using a robotic treadmill training system that uses body weight support belt, and driven gait orthoses (pediatric orthoses) for both legs. |
| Body weight support treadmill training group | Active comparator | Device: Body weight supported treadmill trainingThis group had gait training using while the participant's body weight was supported over the treadmill by the Biodex Unweighting System. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged from 5 to 14 years with bilateral spastic Cerebral palsy (CP) diagnosed by a pediatrician.
- Gross Motor Function Classifications (GMFCS); levels I (walks without limitation), II (walks with limitation), and III (walks using assistive devices).
- Able to follow instructions and accurately signal pain and discomfort.
- Hip and knee passive Range of Motion (ROM) within the minimum range requirement for Robotic-assisted Gait Training (RAGT) (≤ 10⁰ for hip and knee flexion contracture and ≤ 40⁰ for knee valgus).
Key exclusion criteria (12 listed)
- Botox injection for lower limb within the past 4 to 6 months.
- Surgical intervention for lower limbs within an 8-month period before the examination date, including tendon release and muscle lengthening in a 1-year period prior to bone surgery.
- Children using an active drug for resisting epilepsy.
- Anatomical leg length difference greater than 2 centimeters (due to the limitations of the RAGT system).
- Bone-articular instability (joint dislocation).
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 trainingis a robotic treadmill training system that uses body weight support to suspend patients by attaching their legs to robotic legs that help them walk | Device | Robotic assisted gait training group |
| Body weight supported treadmill trainingThe Biodex Unweighting System was used to support the child's body weight, by an adjustable harness placed, over the treadmill. | Device | Body weight support treadmill training group |
Primary outcome
Gait spatio-temporal parameters
Time frame: 1 minute
The Zebris gait analysis system was used in this study to obtain gait spatio-temporal parameters in children with CP. The Zebris gait analysis system consists of a platform that has a sensing area of 200 × 60 cm.
1 secondary outcome
Six-minute walk test (6MWT)
Time frame: 6 minutes
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 3 May 2024.
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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.
Adel A Alhusaini, professor principal investigator
Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud 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 Robotic assisted gait training and Body weight supported treadmill training in people with Cerebral Palsy, run by King Saud University at 1 site in Saudi Arabia.
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 12 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 3 May 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 Saudi Arabia. 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?
Gait spatio-temporal parameters (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.