- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05313633
Plyometric Exercises Versus Wii Training in Children with Unilateral Cerebral Palsy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ethics Statement This study was approved by the Institutional Review Board of the Faculty of Physical Therapy, Cairo University, Egypt and strictly adhered to the criteria proclaimed in the latest version of the Declaration of Helsinki code of ethics. Children's participation will be commissioned by asking their legal guardian to sign a consent form prior to data collection.
A convenient sample of ambulant children with unilateral CP will be recruited from the Out-patient Clinic Faculty of physical therapy, Cairo University and outpatient physical therapy clinics.
Sample size estimation To avoid a type II error, a preliminary power analysis (power =0.8, α=0.05, effect size =0.5) determined a sample size of 28 for this study. Accordingly, 35 children who met the eligible criteria will be included in the current study for possible dropouts.
Randomization The randomization process will be performed using sealed envelopes. The investigator will prepare 35 sealed envelopes that contain a piece of paper indicating whether each participant was in the Wii group (receive Wii training for 45 minutes) or plyometric group (receive plyometric exercises for 45 minutes). The randomization process will be carried out by a registration clerk who was not involved in any part of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Faculty of physical therapy, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 8-12 years;
- able to understand and follow simple commands.
Exclusion Criteria:
- severe uncontrolled seizures;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Wii group
Children in this group will receive a designed physical therapy and occupational therapy programs
|
Both groups received a designed occupational therapy program for 30 minutes
The dose of Wii training was 40 minutes, three times a week for 12 weeks which is an interactive motion-based device.
|
|
Experimental: plyometric group
Children in this group will receive a designed physical therapy and occupational therapy programs and plyometric training
|
Both groups received a designed occupational therapy program for 30 minutes
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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%
|
after 3 months of treatment
|
|
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.
|
after 3 months of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion
Time Frame: after 3 months of treatment
|
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 |
after 3 months of treatment
|
|
Selective motor control
Time Frame: after 3 months of treatment
|
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.
|
after 3 months of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: walaa A El-nabie, Phd, Cairo university, faculty of physical therapy
- Study Director: Hazem A Ali, Phd, Cairo university, faculty of physical therapy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- plyometric training
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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