Cerebral PalsyNCT05506527
Assessment of Respiratory Function Cerebral Palsy Using Plyometric Exercise Sensorimotor Program
A study testing Sensorimotor program and plyometric exercise in people with Cerebral Palsy, run by Egyptian Chinese University at 1 site in Egypt.
Trial summary
To examine if adding plyometric exercises to sensorimotor exercises would improve respiratory function in children and adolescents with cerebral palsy Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Sensorimotor program and plyometric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Jan 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age will be 8 - 14 years.
- children will be assigned to the study are suffering from spastic hemiplegic cerebral palsy (less than grade 1+ om Modified Ashwar Scale)
- Considering the physical problems, children will be chosen according to Growth Motor Function Classification System (GMFCS) with levels I-III
- The ability to understand simple verbal instructions.
Who cannot join
- Visual and hearing impairment; surgery within the last three months preventing them from taking part in sensorimotor physical therapy
- Severe oromotor issues
- Severe chest infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Respiratory Function in Children With Cerebral Palsy Using Combined Plyometric Exercise and Sensorimotor Program: A Randomized Controlled Trial
To examine if adding plyometric exercises to sensorimotor exercises would improve respiratory function in children and adolescents with cerebral palsy
Read the detailed description
Cerebral palsy (CP) is a varied group of developmental disorders secondary to a static immature brain injury that primarily results in persistent nonspecific impairment of movement and posture. Approximately 25% of all CP cases experience disturbance of motor function with unilateral spasticity pertaining to the upper and lower extremities contralateral to the affected cerebral hemisphere and categorized as spastic hemiplegia. Some asymmetries might be noted when hemiplegic children are attempting to perform motor activities. In supported standing, hemiplegic children may stand preferentially on their more functional side and exhibit postural malalignments that impair the ability to transfer body weight on the affected lower extremity.
Children and adolescents with CP have poor respiratory function, secondary to the disease process. Impaired airway clearance, recurrent aspirations, chest infections, poor cough mechanism, impaired lung function, deformity of the spine and chest, and poor nutrition status influence the respiratory condition of children and adults with CP resulting in reduced lung capacity in these individuals.
Plyometric exercises are a specific pattern of resistive strength training in which the muscle starts to contract eccentrically followed by rapid concentric contraction of the same muscle. It can jointly generate high velocity dynamic movements and high-impact force on the muscles and bones. Currently, a limited number of studies have analysed the efficacy of the plyometric training on respiratory function in children with CP or any other disabling health conditions. Preliminary studies have demonstrated the positive effect of plyometric exercises for the gross motor function in boys with unilateral CP.
- Conditions
- Cerebral Palsy
- Being tested
- Sensorimotor program and plyometric exercise
- Keywords
- respiratory capacity, cerebral palsy, plyometric exercise
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor program and plyometric exerciseOther
Children in study group A will receive combined plyometric exercises (vertical paradigm) and sensorimotor program
- Children of the study group B will receive sensorimotor program alone.
| Study group | Role | What they receive |
|---|---|---|
| study group 1 | Experimental | Study group A: will receive combined plyometric exercises and sensorimotor program Receives: Other: Sensorimotor program and plyometric exercise |
| study group 2 | Experimental | Study group B: will receive sensorimotor program alone Receives: Other: Sensorimotor program and plyometric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of spasticity
will be measured by modified Ashower Scale
Measured: six weeks
Secondary outcomes (1)
change of Respiratory capacity and vital capacity
will be measured by incentive spirometry
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Jan 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
- Model description
- randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egyptian Chinese University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelmoneim El Meligy, Egyptian Chinese University
- Investigators
- Eman Abdel-Halim, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506527
- Sponsor's protocol ID
- P.T.REC/012/003787
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 18 Aug 2022
- 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 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Respiratory Function in Children With Cerebral Palsy Using Combined Plyometric Exercise and Sensorimotor Program: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05506527
- Acronym / sponsor ID
- P.T.REC/012/003787
- Conditions
- Cerebral Palsy
- Keywords
- respiratory capacity, cerebral palsy, plyometric exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Egyptian Chinese UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 18 Aug 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.
To examine if adding plyometric exercises to sensorimotor exercises would improve respiratory function in children and adolescents with cerebral palsy
Detailed description
Cerebral palsy (CP) is a varied group of developmental disorders secondary to a static immature brain injury that primarily results in persistent nonspecific impairment of movement and posture. Approximately 25% of all CP cases experience disturbance of motor function with unilateral spasticity pertaining to the upper and lower extremities contralateral to the affected cerebral hemisphere and categorized as spastic hemiplegia. Some asymmetries might be noted when hemiplegic children are attempting to perform motor activities. In supported standing, hemiplegic children may stand preferentially on their more functional side and exhibit postural malalignments that impair the ability to transfer body weight on the affected lower extremity.
Children and adolescents with CP have poor respiratory function, secondary to the disease process. Impaired airway clearance, recurrent aspirations, chest infections, poor cough mechanism, impaired lung function, deformity of the spine and chest, and poor nutrition status influence the respiratory condition of children and adults with CP resulting in reduced lung capacity in these individuals.
Plyometric exercises are a specific pattern of resistive strength training in which the muscle starts to contract eccentrically followed by rapid concentric contraction of the same muscle. It can jointly generate high velocity dynamic movements and high-impact force on the muscles and bones. Currently, a limited number of studies have analysed the efficacy of the plyometric training on respiratory function in children with CP or any other disabling health conditions. Preliminary studies have demonstrated the positive effect of plyometric exercises for the gross motor function in boys with unilateral CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| study group 1 | Experimental | Other: Sensorimotor program and plyometric exerciseStudy group A: will receive combined plyometric exercises and sensorimotor program |
| study group 2 | Experimental | Other: Sensorimotor program and plyometric exerciseStudy group B: will receive sensorimotor program alone |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age will be 8 - 14 years.
- children will be assigned to the study are suffering from spastic hemiplegic cerebral palsy (less than grade 1+ om Modified Ashwar Scale)
- Considering the physical problems, children will be chosen according to Growth Motor Function Classification System (GMFCS) with levels I-III
- The ability to understand simple verbal instructions.
Key exclusion criteria (3 listed)
- Visual and hearing impairment; surgery within the last three months preventing them from taking part in sensorimotor physical therapy
- Severe oromotor issues
- Severe chest infections
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 |
|---|---|---|
| Sensorimotor program and plyometric exerciseChildren in study group A will receive combined plyometric exercises (vertical paradigm) and sensorimotor program - Children of the study group B will receive sensorimotor program alone. | Other | study group 1, study group 2 |
Primary outcome
change of spasticity
Time frame: six weeks
will be measured by modified Ashower Scale
1 secondary outcome
change of Respiratory capacity and vital capacity
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- 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.
Eman Abdel-Halim study director
Cairo 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 Sensorimotor program and plyometric exercise in people with Cerebral Palsy, run by Egyptian Chinese 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 4 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 18 Aug 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 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 Mohamed Abo-El-Ros, Ph.D (+201206530584, maboelroose@ecu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of spasticity (time frame: six weeks). 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 18 Aug 2022.