Cerebral PalsyNCT05819216
Support Versus Loaded Treadmill Training in Treatment of Children With Cerebral Palsy
A study testing Treadmill in people with Cerebral Palsy, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
Background: Children often suffer from disorders that alter their walking functions, such as cerebral palsy. Task-oriented training is one of the recent interventions to improve gait in children with cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- May 2023to Oct 2023
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 4 to 10.
- Children with CP.
- Diplegic or quadriplegic CP regardless of the tonal abnormality.
- Ambulant with or without assistive devices.
- GMFCS = II-III.
- Able to stand and hold.
Who cannot join
- Children with hemiplegic CP
- Non-ambulant children
- Children with comorbidities.
- Fixed contractures.
- Severely affected CP.
- Severe cognitive or communicative impairment.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Imam Abdulrahman Bin Faisal University
Dammam, Eastern Province, 34221
ABDULMAJEED ALOTAIBI, PhD, +966505795288, 2220700003@iau.edu.sa
About this study
Official title: Partial Body Weight Support Treadmill Training Versus Loaded Treadmill Training in Treatment of Children With Cerebral Palsy: A Randomized Clinical Trial
Background: Children often suffer from disorders that alter their walking functions, such as cerebral palsy. Task-oriented training is one of the recent interventions to improve gait in children with cerebral palsy (CP). Some studies have shown the effectiveness of Partial Body Weight Support Treadmill Training (PBWSTT) for children with cerebral palsy. Another study supports the effectiveness of Loaded Treadmill Training (LTT) by placing additional weight on the lower extremity. There is still inconsistency in the results of studies advising which weight support or weight addition is more appropriate to use in improving walking in children with cerebral palsy.
Objectives: This study aims to investigate the effectiveness of PBWSTT in the treatment of children with CP. Furthermore, to compare the effectiveness of LTT with PBWSTT.
Read more
Methods: Two groups of twenty-two children with spastic cerebral palsy will be involved. Ages 4 to 10 and Gross Motor Functional Classification System (GMFCS) I -III. PBWSTT includes a 45- minute treadmill training session with 30% weight support for group one and LTT by adding 60% weight to lower limb while treadmill training for the second group. Spatiotemporal parameters will be measure additional to balance and endurance functions.
Statistical analysis: Independent t test will be used to detect between group differences and paired t test to detect before and after trial differences. Significance level less than 0.05 and confidence interval 95%.
Study design: Randomized Clinical Trial (Parallel Arm Design).
Read the detailed description
Study design:
A randomized clinical trial (parallel arm design) will compare the pre- and post-intervention effects of Partial Body Weight Support Treadmill Training and Loaded Treadmill Training.
Participants:
A convenience sampling technique will be used to recruit the children with cerebral palsy aged between 4 and 10 years who had Gross Motor Functional Classification System (GMFCS) from I to III and who could stand and hold. Children will be recruited from the Children's Hospital, Taif, Saudi Arabia.
Interventions:
the pre-and post-intervention effects of Partial Body Weight Support Treadmill Training and Loaded Treadmill Training will be compared. All children will be randomly divided into two groups. Both groups will receive 45-minute treadmill training sessions for 8 weeks (3 sessions per week) with a total of 25 sessions.
First group: (Partial Body Weight Support Treadmill Training) Involve administration of conventional treatment sessions. Further, sessions of Partial Body Weight Support Treadmill Training will be given at the rehabilitation center, outpatient clinic. Partial Body Weight Support Treadmill Training involves a motorized treadmill with an attached unweighting system of 30% of each participant's body weight will be decreased. The treatment session lasts for 45 min (3 sessions/ week, for 8 weeks). A gradual decrease in unweight percentage, that keep knee extended during the stance phase. All procedures will be with assistance and under the observation of a well-trained pediatric physical therapist with an adequate experience with treadmill settings.
Second group: (Loaded Treadmill Training) Will receive a loaded treadmill training in addition to the conventional treatment sessions. Loaded Treadmill Training includes a motorized treadmill with an additional load attached to the child's lower extremities. A 60% mass lower limb weight will be added gradually and upon the child's tolerance. These procedures will be introduced under the supervision of a pediatric physical therapist with experience with treadmill settings. Furthermore, both groups will get the same conventional therapy that includes a range of motion, neurodevelopmental approach, and impairment-based therapies such as stretching and strengthening exercises for 30 minutes three times per week for 8 weeks.
- Conditions
- Cerebral Palsy
- Being tested
- Treadmill
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreadmillDevice
Also called Treadmill training
Gait training on treadmill training
| Study group | Role | What they receive |
|---|---|---|
| partial body weight support treadmill training group | Experimental | A set of 24 sessions of partial body weight support treadmill training involve administration of a motorized treadmill with an attached overhead unweighting system of 30% of each participant's body weight will be decreased. The treatment session lasts for 45 min (3 sessions/ week, for 8 weeks). Receives: Device: Treadmill |
| loaded treadmill training group | Experimental | A set of 24 sessions of loaded treadmill training includes a motorized treadmill with an additional load (sand bags) attached to the child's lower extremities. A 60% mass lower limb weight will be added. Receives: Device: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait kinematics analysis: 3 dimensional motion capture system
The system to be employed is the VICON Gait Analysis System, which uses a group of ten cameras to record the motion of the lower limbs.
Measured: Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.
Secondary outcomes (4)
Gross Motor Functional Measure-66
Gross Motor Functional Measure (D and E dimensions) to measure changes in gross motor functions over time. It is an observational instrument used to capture changes in gross motor function in children with cerebral palsy.
Measured: Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.
Biodex Balance System (BBS)
IT is a multiaxial device that objectively measures and records an individual's ability to stabilize the involved joint under dynamic stress. It uses a circular platform that is free to move in the anterior-posterior and medial-lateral axes simultaneously.
Measured: Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.
Biodex System 4 - Isokinetic Dynamometer
Biodex isokinetic dynamometer allows to evaluate strength, endurance, power and range of motion of all major joints and muscles, and provides highly detailed objective data results of their performance.
Measured: Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.
Functional Reach Test (FRT)
It is a single task performance outcome measure that assesses the child's stability to detect the functional dynamic balance, which includes a wooden bar flexible to be adjusted to the child's height.
Measured: Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionOct 2023 (estimated)
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulmajeed Nasser Alotaibi, Imam Abdulrahman Bin Faisal University
- Investigators
- Dr. Alaa Ibrahim, PhD, Study director, Imam Abdulrahman Bin Fisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819216
- Sponsor's protocol ID
- 45178
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Body Weight Support Treadmill Training Versus Loaded Treadmill Training in Treatment of Children With Cerebral Palsy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05819216
- Acronym / sponsor ID
- 45178
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 19 Apr 2023 (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.
Background: Children often suffer from disorders that alter their walking functions, such as cerebral palsy. Task-oriented training is one of the recent interventions to improve gait in children with cerebral palsy (CP). Some studies have shown the effectiveness of Partial Body Weight Support Treadmill Training (PBWSTT) for children with cerebral palsy. Another study supports the effectiveness of Loaded Treadmill Training (LTT) by placing additional weight on the lower extremity. There is still inconsistency in the results of studies advising which weight support or weight addition is more appropriate to use in improving walking in children with cerebral palsy.
Objectives: This study aims to investigate the effectiveness of PBWSTT in the treatment of children with CP. Furthermore, to compare the effectiveness of LTT with PBWSTT.
Methods: Two groups of twenty-two children with spastic cerebral palsy will be involved. Ages 4 to 10 and Gross Motor Functional Classification System (GMFCS) I -III. PBWSTT includes a 45- minute treadmill training session with 30% weight support for group one and LTT by adding 60% weight to lower limb while treadmill training for the second group. Spatiotemporal parameters will be measure additional to balance and endurance functions.
Statistical analysis: Independent t test will be used to detect between group differences and paired t test to detect before and after trial differences. Significance level less than 0.05 and confidence interval 95%.
Study design: Randomized Clinical Trial (Parallel Arm Design).
Detailed description
Study design:
A randomized clinical trial (parallel arm design) will compare the pre- and post-intervention effects of Partial Body Weight Support Treadmill Training and Loaded Treadmill Training.
Participants:
A convenience sampling technique will be used to recruit the children with cerebral palsy aged between 4 and 10 years who had Gross Motor Functional Classification System (GMFCS) from I to III and who could stand and hold. Children will be recruited from the Children's Hospital, Taif, Saudi Arabia.
Interventions:
the pre-and post-intervention effects of Partial Body Weight Support Treadmill Training and Loaded Treadmill Training will be compared. All children will be randomly divided into two groups. Both groups will receive 45-minute treadmill training sessions for 8 weeks (3 sessions per week) with a total of 25 sessions.
First group: (Partial Body Weight Support Treadmill Training) Involve administration of conventional treatment sessions. Further, sessions of Partial Body Weight Support Treadmill Training will be given at the rehabilitation center, outpatient clinic. Partial Body Weight Support Treadmill Training involves a motorized treadmill with an attached unweighting system of 30% of each participant's body weight will be decreased. The treatment session lasts for 45 min (3 sessions/ week, for 8 weeks). A gradual decrease in unweight percentage, that keep knee extended during the stance phase. All procedures will be with assistance and under the observation of a well-trained pediatric physical therapist with an adequate experience with treadmill settings.
Second group: (Loaded Treadmill Training) Will receive a loaded treadmill training in addition to the conventional treatment sessions. Loaded Treadmill Training includes a motorized treadmill with an additional load attached to the child's lower extremities. A 60% mass lower limb weight will be added gradually and upon the child's tolerance. These procedures will be introduced under the supervision of a pediatric physical therapist with experience with treadmill settings. Furthermore, both groups will get the same conventional therapy that includes a range of motion, neurodevelopmental approach, and impairment-based therapies such as stretching and strengthening exercises for 30 minutes three times per week for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| partial body weight support treadmill training group | Experimental | Device: TreadmillA set of 24 sessions of partial body weight support treadmill training involve administration of a motorized treadmill with an attached overhead unweighting system of 30% of each participant's body weight will be decreased. The treatment session lasts for 45 min (3 sessions/ week, for 8 weeks). |
| loaded treadmill training group | Experimental | Device: TreadmillA set of 24 sessions of loaded treadmill training includes a motorized treadmill with an additional load (sand bags) attached to the child's lower extremities. A 60% mass lower limb weight will be added. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged between 4 to 10.
- Children with CP.
- Diplegic or quadriplegic CP regardless of the tonal abnormality.
- Ambulant with or without assistive devices.
- GMFCS = II-III.
Key exclusion criteria (6 listed)
- Children with hemiplegic CP
- Non-ambulant children
- Children with comorbidities.
- Fixed contractures.
- Severely affected CP.
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 |
|---|---|---|
| TreadmillAlso: Treadmill trainingGait training on treadmill training | Device | loaded treadmill training group, partial body weight support treadmill training group |
Primary outcome
Gait kinematics analysis: 3 dimensional motion capture system
Time frame: Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.
The system to be employed is the VICON Gait Analysis System, which uses a group of ten cameras to record the motion of the lower limbs.
4 secondary outcomes
Gross Motor Functional Measure-66
Time frame: Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.
Biodex Balance System (BBS)
Time frame: Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.
Biodex System 4 - Isokinetic Dynamometer
Time frame: Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.
Functional Reach Test (FRT)
Time frame: Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Alaa Ibrahim, PhD study director
Imam Abdulrahman Bin Fisal 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 Treadmill in people with Cerebral Palsy, run by Imam Abdulrahman Bin Faisal 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 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdulmajeed Alotaibi, M.Sc. (+966505795288, 2220700003@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait kinematics analysis: 3 dimensional motion capture system (time frame: Two time points to measure change over two months. First point, before administration of the first treatment session. Second point immediately after finishing the treatment sessions.). 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 19 Apr 2023.