DiplegiaNCT05609422
Scooter Board Activities in Diplegic Cerebral Palsy
A study testing Physical therapy program and scooter board activities in people with Diplegia, run by Badr University at 1 site in Egypt.
Trial summary
Children with CP may have muscle weakness, changes in mobility, posture, muscle tone, motor coordination and deficits in postural control. These changes, individually or collectively, affect psychomotor function. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Diplegia
- What is being tested?
- Physical therapy program and scooter board activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2022to 8 Apr 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- CP with a diplegia
- Age 7 to 11 years
- Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).
- They could walk with limitation or holding on according to GMFCS (level I\&II \&III) (Palisano et al., 1997).
- They were able to understand and follow verbal instructions
Who cannot join
- Children with any surgical interference in the upper limb.
- intellectual disability such that simple tasks could not be understood or executed.
- Children with any visual or auditory problems.
- Children with any surgical interference in the lower limb.
- Children with any structural deformities in joints and bones of lower limbs.
- Children who suffer from other diseases or associated disorders that interfered with physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Scooter Board Activities on Trunk Postural Control and Gait in Children With Diplegic Cerebral Palsy
Children with CP may have muscle weakness, changes in mobility, posture, muscle tone, motor coordination and deficits in postural control. These changes, individually or collectively, affect psychomotor function. As a result, activities that are performed quickly and readily by healthy children may be difficult and time-consuming for children with CP.
Read the detailed description
Similar vestibular stimulation can be provided with ascooter-board which requires more active participation on the part of the child. A scooter-board is simply a wooden board mounted on four castors so that it can roll freely and spin in any direction, it should be big enough to support the middle part of the body while the head, upper chest and legs hang off the ends.
- Conditions
- Diplegia
- Being tested
- Physical therapy program, scooter board activities
- Keywords
- diplegia, cerebral palsy, core stability, trunk control
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy programOther
- Stretching exercises
- Strength Training Kneeling exercises
- Standing exercises
- Gait Training
scooter board activitiesOther
- Scooter board bear walk.
- Scooter board crab walk.
- Sitting on scooter board, use it to move forward and backward, move the pool rings from one end to another.
- Cross sitting on scooter board, pulls along the rope using his/her hands
- Sit with knees pulled into the chest (like a bug pose) and move around with arms only.
- Prone over scooter board, pulling rope to move forward. Pull self along an anchored rope to retrieve items
- Scooter rolls outs. Place knees on floor and hands holding the edge of the front scooter board. Push board out a few inches then pull back, the further you roll, the harder it gets.
- Kneeling, Push self forward and backward with the use of a therapy ball (lots of Motor Planning).
- Supine flexion on scooter board, Clip clothespins to a rope hanging above.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Received the designed physical therapy program. Receives: Other: Physical therapy program |
| study group | Experimental | Received a designed physical therapy program in addition to scooter bord activities. Receives: Other: Physical therapy program; Other: scooter board activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk control measurement scale (TCMS)
TCMS measures trunk control in two basic components:
static and dynamic sitting balance. Balance is assessed during flexion, extension, lateral flexion, and rotation movements as selective movements of dynamic sitting. Total score ranges between 0 and 58, and higher scores indicate better control
Measured: 3 months
2D video-based gait assessment system
2D video-based gait assessment system to measure lateral trunk sway at SLS from frontal view
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start11 Nov 2022
- Primary completion12 Mar 2023
- Study completion8 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- The selected subjects will be divided into two groups of equal numbers (control and study).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnya Samy Abdallah Ghoneim, Badr University
- Investigators
- Omnya samy, PHD, Principal investigator, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609422
- Sponsor's protocol ID
- Omnya 2
- Status last verified
- Apr 2023
- First submitted
- 2 Nov 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Private data for this research
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Scooter Board Activities on Trunk Postural Control and Gait in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05609422
- Acronym / sponsor ID
- Omnya 2
- Conditions
- Diplegia
- Keywords
- diplegia, cerebral palsy, core stability, trunk control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 12 Mar 2023 (actual)
- Study completion
- 8 Apr 2023 (actual)
- First posted
- 8 Nov 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.
Children with CP may have muscle weakness, changes in mobility, posture, muscle tone, motor coordination and deficits in postural control. These changes, individually or collectively, affect psychomotor function. As a result, activities that are performed quickly and readily by healthy children may be difficult and time-consuming for children with CP.
Detailed description
Similar vestibular stimulation can be provided with ascooter-board which requires more active participation on the part of the child. A scooter-board is simply a wooden board mounted on four castors so that it can roll freely and spin in any direction, it should be big enough to support the middle part of the body while the head, upper chest and legs hang off the ends.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The selected subjects will be divided into two groups of equal numbers (control and study).
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Physical therapy programReceived the designed physical therapy program. |
| study group | Experimental | Other: Physical therapy program, Other: scooter board activitiesReceived a designed physical therapy program in addition to scooter bord activities. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- CP with a diplegia
- Age 7 to 11 years
- Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).
- They could walk with limitation or holding on according to GMFCS (level I\&II \&III) (Palisano et al., 1997).
- They were able to understand and follow verbal instructions
Key exclusion criteria (6 listed)
- Children with any surgical interference in the upper limb.
- intellectual disability such that simple tasks could not be understood or executed.
- Children with any visual or auditory problems.
- Children with any surgical interference in the lower limb.
- Children with any structural deformities in joints and bones of lower limbs.
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 |
|---|---|---|
| Physical therapy program* Stretching exercises * Strength Training Kneeling exercises * Standing exercises * Gait Training | Other | control group, study group |
| scooter board activities1. Scooter board bear walk. 2. Scooter board crab walk. 3. Sitting on scooter board, use it to move forward and backward, move the pool rings from one end to another. 4. Cross sitting on scooter board, pulls along the rope using his/her hands 5. Sit with knees pulled into the chest (like a bug pose) and move around with arms only. 6. Prone over scooter board, pulling rope to move forward. Pull self along an anchored rope to retrieve items 7. Scooter rolls outs. Place knees on floor and hands holding the edge of the front scooter board. Push board out a few inches then pull back, the further you roll, the harder it gets. 8. Kneeling, Push self forward and backward with the use of a therapy ball (lots of Motor Planning). 9. Supine flexion on scooter board, Clip clothespins to a rope hanging above. | Other | study group |
Primary outcome
Trunk control measurement scale (TCMS)
Time frame: 3 months
TCMS measures trunk control in two basic components: static and dynamic sitting balance. Balance is assessed during flexion, extension, lateral flexion, and rotation movements as selective movements of dynamic sitting. Total score ranges between 0 and 58, and higher scores indicate better control
2D video-based gait assessment system
Time frame: 3 months
2D video-based gait assessment system to measure lateral trunk sway at SLS from frontal view
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 11 Apr 2023.
- Individual participant dataSharing planned: No. Private data for this research
Related trials for Diplegia
Not yet recruiting
Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia Cerebral Palsy
Recruiting
Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy
Spastic Diplegic Cerebral Palsy
Recruiting
Effect of Virtual Reality Mediated Gamified Rehabilitation in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegic Cerebral Palsy
Active, not recruiting
Effect of Reactive Functional Motor Challenge Training on Dynamic Balance and Functional Mobility in Children With Spastic Diplegic Cerebral Palsy: A Randomized Comparative Trial.
Cerebral Palsy (CP), Spastic Diplegia Cerebral Palsy
Active, not recruiting
Oculomotor Training in Spastic Diplegia: Effects on Postural Stability and Motor Proficiency
Cerebral Palsy Spastic Diplegia
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.
Omnya samy, PHD principal investigator
lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy program and scooter board activities in people with Diplegia, run by Badr University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 11 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 Egypt. 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?
Trunk control measurement scale (TCMS) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 11 Apr 2023.