Sports Physical TherapyNCT05313633
Plyometric Exercises Versus Wii Training in Children with Unilateral Cerebral Palsy
A study testing Occupational therapy, Plyometric training and Wii training in people with Sports Physical Therapy, run by Cairo University at 1 site in Egypt.
Trial summary
Plyometric training includes muscle contraction that moves rapidly from the eccentric to the concentric phase of movement while using proper biomechanics. It is an effective neuromuscular stimulus that can improve motor functions of children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Occupational therapy, Plyometric training and Wii training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Mar 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged 8-12 years;
- able to understand and follow simple commands.
Who cannot join
- severe uncontrolled seizures;
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of physical therapy, Cairo university
Giza, Giza Governorate
About this study
Official title: Efficacy of Plyometric Exercises Versus Wii Training on Upper Extremity Function in Children with Unilateral Cerebral Palsy: a Randomized Controlled Trial
Plyometric training includes muscle contraction that moves rapidly from the eccentric to the concentric phase of movement while using proper biomechanics. It is an effective neuromuscular stimulus that can improve motor functions of children with cerebral palsy. In plyometric training, muscles exert maximum force in short intervals of time, with the goal of increasing power.
Commercially available video games have been used for a wide range of clinical populations with generally positive clinical outcomes. They have been shown to be active enough to provide an increase in energy expenditure and physical activity in children with cerebral palsy. Furthermore, an early case study showed improvements in visual-perceptual processing, balance, and mobility in a child with cerebral palsy.
- Conditions
- Sports Physical Therapy
- Being tested
- Occupational therapy, Plyometric training, Wii training
- Keywords
- Cerebral palsy, Unilateral Cerebral Palsy, hand grip strength, upper extremity function, range of motion, Wii training, plyometric exercises
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational therapyOther
Both groups received a designed occupational therapy program for 30 minutes
Plyometric trainingOther
The designed plyometric training program basically focuses on upper extremity strength training and is developed according to the guidelines of the National Strength and Conditioning Association.
Wii trainingOther
The dose of Wii training was 40 minutes, three times a week for 12 weeks which is an interactive motion-based device.
| Study group | Role | What they receive |
|---|---|---|
| Wii group | Experimental | Children in this group will receive a designed physical therapy and occupational therapy programs Receives: Other: Occupational therapy; Other: Wii training |
| plyometric group | Experimental | Children in this group will receive a designed physical therapy and occupational therapy programs and plyometric training Receives: Other: Occupational therapy; Other: Plyometric training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity function
The quality of upper extremity skill test is a reliable and valid tool used to measure the motor function in children with cerebral palsy. The total scores for each domain percentage score range from zero to 100%
Measured: after 3 months of treatment
Hand grip strength
The hand held dynamometer (Patterson Medical, Warrenville, IL, USA) is a valid and reliable tool to assess grip strength. Each child performs three trials and the mean will be recorded in kilogram for statistical analysis.
Measured: after 3 months of treatment
Secondary outcomes (2)
Range of motion
An electronic goniometer will be used for the measurements of ROM of the affected upper limb in order to accurately track progress in a rehabilitation program.
Shoulder flexion and abduction, elbow extension, forearm supination and wrist extension will be measured for all children before and after treatment
Measured: after 3 months of treatment
Selective motor control
Test of arm selective control, a valid and reliable tool, will be used to measure selectivity of upper extremity with total score for each upper extremity is 16 and 32 for both tested upper extremities.
Measured: after 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Apr 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mahmoud Abd-elmonem, Cairo University
- Investigators
- walaa A El-nabie, Phd, Study chair, Cairo university, faculty of physical therapyHazem A Ali, Phd, Study director, Cairo university, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313633
- Sponsor's protocol ID
- plyometric training
- Status last verified
- Dec 2022
- First submitted
- 7 Mar 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Plyometric Exercises Versus Wii Training on Upper Extremity Function in Children with Unilateral Cerebral Palsy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05313633
- Acronym / sponsor ID
- plyometric training
- Conditions
- Sports Physical Therapy
- Keywords
- Cerebral palsy, Unilateral Cerebral Palsy, hand grip strength, upper extremity function, range of motion, Wii training, plyometric exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 6 Apr 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.
Plyometric training includes muscle contraction that moves rapidly from the eccentric to the concentric phase of movement while using proper biomechanics. It is an effective neuromuscular stimulus that can improve motor functions of children with cerebral palsy. In plyometric training, muscles exert maximum force in short intervals of time, with the goal of increasing power.
Commercially available video games have been used for a wide range of clinical populations with generally positive clinical outcomes. They have been shown to be active enough to provide an increase in energy expenditure and physical activity in children with cerebral palsy. Furthermore, an early case study showed improvements in visual-perceptual processing, balance, and mobility in a child with cerebral palsy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wii group | Experimental | Other: Occupational therapy, Other: Wii trainingChildren in this group will receive a designed physical therapy and occupational therapy programs |
| plyometric group | Experimental | Other: Occupational therapy, Other: Plyometric trainingChildren in this group will receive a designed physical therapy and occupational therapy programs and plyometric training |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- aged 8-12 years;
- able to understand and follow simple commands.
Key exclusion criteria (1 listed)
- severe uncontrolled seizures;
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 |
|---|---|---|
| Occupational therapyBoth groups received a designed occupational therapy program for 30 minutes | Other | Wii group, plyometric group |
| Plyometric trainingThe designed plyometric training program basically focuses on upper extremity strength training and is developed according to the guidelines of the National Strength and Conditioning Association. | Other | plyometric group |
| Wii trainingThe dose of Wii training was 40 minutes, three times a week for 12 weeks which is an interactive motion-based device. | Other | Wii group |
Primary outcome
Upper extremity function
Time frame: after 3 months of treatment
The quality of upper extremity skill test is a reliable and valid tool used to measure the motor function in children with cerebral palsy. The total scores for each domain percentage score range from zero to 100%
Hand grip strength
Time frame: after 3 months of treatment
The hand held dynamometer (Patterson Medical, Warrenville, IL, USA) is a valid and reliable tool to assess grip strength. Each child performs three trials and the mean will be recorded in kilogram for statistical analysis.
2 secondary outcomes
Range of motion
Time frame: after 3 months of treatment
Selective motor control
Time frame: after 3 months of treatment
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 18 Nov 2024.
- 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.
walaa A El-nabie, Phd study chair
Cairo university, faculty of physical therapy
Hazem A Ali, Phd study director
Cairo university, faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational therapy, Plyometric training and Wii training in people with Sports Physical Therapy, 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 2 inclusion and 1 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 18 Nov 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 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?
Upper extremity function (time frame: after 3 months of treatment). 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 18 Nov 2024.