Cerebral PalsyNCT04712708
Role of Rebound Therapy in the Rehabilitation of Children With Spastic Cerebral Palsy
A study testing Rebound Therapy and Physical Therapy Program in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Cerebral palsy (CP) is a group of disorders of movement and posture, causing several body impairments. CP is caused by non-progressive disturbance that occurred in the fetal or immature brain. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Rebound Therapy and Physical Therapy Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 30 Jul 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic cerebral palsy was determined according to the sample size calculation, was selected from the outpatient's clinic of the faculty of Physical Therapy Cairo University.
- Level I according to the Gross Motor Function Classification System (GMFCS). Chronological age ranged from 5 to 11 years.
- Height was above 1 meter.
- Understand verbal command.
- The degree of spasticity ranged from 1 to 1+ according to Modified Ashworth' Scale.
- Rebound therapy using trampoline was used as the method of management in the study group in addition to the selected physical therapy program that was used in both groups, and the treatment sessions was provided in the out-patient clinic of the faculty of Physical Therapy Cairo University.
Who cannot join
- Vertigo or dizziness.
- Epilepsy.
- Osteoporosis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Giza
Faten Abdelaziem, PhD, +20 100 855 4818, faten.hassan@pt.cu.edu.eg
About this study
Cerebral palsy (CP) is a group of disorders of movement and posture, causing several body impairments. CP is caused by non-progressive disturbance that occurred in the fetal or immature brain. CP symptoms include several motor disorders such as disturbances in sensation, coordination, cognition, communication and behavior in addition to disturbances in postural stability, balance and coordination.
Balance is the ability to maintain the center of body mass over the base of support. CP causes balance impairment which results in decrease in the child's mobility functions and causing activity limitation and participations restrictions.
Read more
Motor coordination is the registration of two or more things such as body movements , timing or sensory feedback into a harmonious relationship.
CP causes disturbances in motor coordination such as difficulties in the routine gross movements as running and jumping, and disturbances in common fine movements like buttoning, clothing or brushing hair Rebound therapy is an exercise therapy which uses mini trampolines, rebounders , Springfree Trampoline and Swiss balls, to provide opportunity to perform recreational movements for individuals with different body structural and functional impairments.
- Conditions
- Cerebral Palsy
- Being tested
- Rebound Therapy, Physical Therapy Program
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebound TherapyDevice
Rebound therapy is the therapeutic use of full sized trampoline or mini sized trampoline. It provides opportunities for exercise recreation and therapy; and it is distinct from gymnastic trampolining. It is used for facilitating movements, improving balance, enhancing coordination and promoting motor performances in children with different disorders includes learning disabilities, communication disorders and motor dysfunction (Rebound Therapy South Africa, 2020; The Chartered society of Physiotherapists, 2016).
Physical Therapy ProgramOther
The Mat Exercises:
Stretching exercises to all spastic muscle groups (Kalkman et al., 2018). Gentle exercises was applied for 40-60 seconds and repeated from 3-5 times/ movement as supported by (Fragala et al., 2003).
Strengthening Exercises:
Dynamic Rising Positioning
The Gym Exercises:
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Eighteen children with spastic CP will receive especially designed physical therapy program based on Neuro-Developmental treatment (NDT) approach with emphasis on exercise encourage independent standing, stretches exercises, strengthening exercises, approximation, enhancement and facilitation of gait patterning and ankle ROM exercises for one hour for 24 sessions Receives: Other: Physical Therapy Program |
| Study Group | Experimental | ighteen children with spastic CP will receive the same program that the control group received in addition to especially designed exercises using rebound therapy (Mini Trampoline) that include push up exercise, standing, squatting, single limb squatting, kneeling position, catching and throwing a ball over head in kneeling position, catching and throwing a ball over head in standing position, kicking the ball, broad jumping with assistance, jumping in place, for 1 hour three times per week for three successive months. Receives: Device: Rebound Therapy; Other: Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Stationary Balance Using Biodex Balance System
Measured: 12 Weeks
Gross Motor Function
Gross Motor Function using Gross Motor Function Measure (GMFM)
Measured: 12 Weeks
Gross Motor Coordination
Gross Motor Coordination Using Gross Motor Coordination Quotient in BOT-2
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Nov 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (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.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Faten Hassan Abdelaziem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712708
- Sponsor's protocol ID
- P.T. REC/012/002421
- Status last verified
- Dec 2020
- First submitted
- 4 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Rebound Therapy in the Rehabilitation of Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04712708
- Acronym / sponsor ID
- P.T. REC/012/002421
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 15 Jan 2021 (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.
Cerebral palsy (CP) is a group of disorders of movement and posture, causing several body impairments. CP is caused by non-progressive disturbance that occurred in the fetal or immature brain. CP symptoms include several motor disorders such as disturbances in sensation, coordination, cognition, communication and behavior in addition to disturbances in postural stability, balance and coordination.
Balance is the ability to maintain the center of body mass over the base of support. CP causes balance impairment which results in decrease in the child's mobility functions and causing activity limitation and participations restrictions.
Motor coordination is the registration of two or more things such as body movements , timing or sensory feedback into a harmonious relationship.
CP causes disturbances in motor coordination such as difficulties in the routine gross movements as running and jumping, and disturbances in common fine movements like buttoning, clothing or brushing hair Rebound therapy is an exercise therapy which uses mini trampolines, rebounders , Springfree Trampoline and Swiss balls, to provide opportunity to perform recreational movements for individuals with different body structural and functional impairments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Physical Therapy ProgramEighteen children with spastic CP will receive especially designed physical therapy program based on Neuro-Developmental treatment (NDT) approach with emphasis on exercise encourage independent standing, stretches exercises, strengthening exercises, approximation, enhancement and facilitation of gait patterning and ankle ROM exercises for one hour for 24 sessions |
| Study Group | Experimental | Device: Rebound Therapy, Other: Physical Therapy Programighteen children with spastic CP will receive the same program that the control group received in addition to especially designed exercises using rebound therapy (Mini Trampoline) that include push up exercise, standing, squatting, single limb squatting, kneeling position, catching and throwing a ball over head in kneeling position, catching and throwing a ball over head in standing position, kicking the ball, broad jumping with assistance, jumping in place, for 1 hour three times per week for three successive months. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Spastic cerebral palsy was determined according to the sample size calculation, was selected from the outpatient's clinic of the faculty of Physical Therapy Cairo University.
- Level I according to the Gross Motor Function Classification System (GMFCS). Chronological age ranged from 5 to 11 years.
- Height was above 1 meter.
- Understand verbal command.
- The degree of spasticity ranged from 1 to 1+ according to Modified Ashworth' Scale.
Key exclusion criteria (3 listed)
- Vertigo or dizziness.
- Epilepsy.
- Osteoporosis.
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 |
|---|---|---|
| Rebound TherapyRebound therapy is the therapeutic use of full sized trampoline or mini sized trampoline. It provides opportunities for exercise recreation and therapy; and it is distinct from gymnastic trampolining. It is used for facilitating movements, improving balance, enhancing coordination and promoting motor performances in children with different disorders includes learning disabilities, communication disorders and motor dysfunction (Rebound Therapy South Africa, 2020; The Chartered society of Physiotherapists, 2016). | Device | Study Group |
| Physical Therapy ProgramThe Mat Exercises: Stretching exercises to all spastic muscle groups (Kalkman et al., 2018). Gentle exercises was applied for 40-60 seconds and repeated from 3-5 times/ movement as supported by (Fragala et al., 2003). Strengthening Exercises: Dynamic Rising Positioning The Gym Exercises: | Other | Control Group, Study Group |
Primary outcome
Balance
Time frame: 12 Weeks
Stationary Balance Using Biodex Balance System
Gross Motor Function
Time frame: 12 Weeks
Gross Motor Function using Gross Motor Function Measure (GMFM)
Gross Motor Coordination
Time frame: 12 Weeks
Gross Motor Coordination Using Gross Motor Coordination Quotient in BOT-2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rebound Therapy and Physical Therapy Program in people with Cerebral Palsy, run by Cairo 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 6 inclusion and 3 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 15 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faten Abdelaziem, PhD (+20 100 855 4818, faten.hassan@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 12 Weeks). 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?
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 15 Jan 2021.