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Plyometric Exercises Versus Wii Training In Children With Unilateral Cerebral Palsy

Primary Purpose

Sports Physical Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Designed physical therapy
Occupational therapy
Plyometric training
Wii training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sports Physical Therapy focused on measuring Cerebral palsy, Unilateral Cerebral Palsy, hand grip strength, upper extremity function, range of motion, Wii training, plyometric exercises

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged 8-12 years;
  • both sexes;
  • had a diagnosis of spastic hemiplegia obtained from medical records;
  • level I-III on the Manual Ability Classification System (MACS)
  • able to understand and follow simple commands.

Exclusion Criteria:

  • Botox injection/surgery in the affected upper extremity within the past 6 months;
  • severe uncontrolled seizures;
  • fixed deformities in the affected side
  • attention deficit disorders

Sites / Locations

  • faculty of physical therapy, Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Wii group

plyometric group

Arm Description

Children in this group will receive a designed physical therapy and occupational therapy programs prescribed individually for each child based on the functional capacity of each child (each program lasted for 30 minutes). Additionally, a 30- minute rest period will be implemented before receiving the allocated intervention. This group will receive a Wii training program for 45 minutes The treatment will be implemented three sessions a week for three months period.

Children in this group will receive a designed physical therapy and occupational therapy programs prescribed individually for each child based on the functional capacity of each child (each program lasted for 30 minutes). Additionally, a 30- minute rest period will be implemented before receiving the allocated intervention. This group will receive a plyometric training program for 45 minutes The treatment will be implemented three sessions a week for three months period.

Outcomes

Primary Outcome Measures

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 ages of 18 months to 8 years in four basic domains representing dissociated movement; grasp; protective extension; and weight bearing. The total scores for each domain percentage score are calculated as total score which range from zero to 100% with higher score reflects better performance.
Hand grip strength
The hand held dynamometer (Patterson Medical, Warrenville, IL, USA) is a valid and reliable tool to assess grip strength in typically developing and disabled children recorded in kilogram. The assessment will be carried out with the child sitting on a chair with back support with suitable height to maintain the hips and knees at right angles and feet maintained on the supporting surface in neutral position. The tested upper extremity is aligned beside the body forearm and wrist in neutral positions with 90o elbow flexion. Then, each child is instructed to maximally compress the handle of the dynamometer. Each child performs three trials and the mean will be recorded in kilogram for statistical analysis.

Secondary Outcome Measures

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
Selective motor control
Test of arm selective control, a valid and reliable tool, will be used to measure selectivity of upper extremity of shoulder; elbow; wrist; fingers movements and thumb extension (key grip) as described in in the illustrated guide for administration and scoring. For each movement, the examiner passively moves the tested upper extremity to assess the full range of motion and demonstrate the desired movement. Then, he/she is instructed to actively move the test upper extremity using a three-second verbal count. Each position is scored as unable (0); impaired (1) or intact SVMC (2) with total score for each upper extremity is 16 and 32 for both tested upper extremities.

Full Information

First Posted
March 7, 2022
Last Updated
December 6, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05313633
Brief Title
Plyometric Exercises Versus Wii Training In Children With Unilateral Cerebral Palsy
Official Title
Efficacy Of Plyometric Exercises Versus Wii Training On Upper Extremity Function In Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sports Physical Therapy
Keywords
Cerebral palsy, Unilateral Cerebral Palsy, hand grip strength, upper extremity function, range of motion, Wii training, plyometric exercises

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wii group
Arm Type
Experimental
Arm Description
Children in this group will receive a designed physical therapy and occupational therapy programs prescribed individually for each child based on the functional capacity of each child (each program lasted for 30 minutes). Additionally, a 30- minute rest period will be implemented before receiving the allocated intervention. This group will receive a Wii training program for 45 minutes The treatment will be implemented three sessions a week for three months period.
Arm Title
plyometric group
Arm Type
Experimental
Arm Description
Children in this group will receive a designed physical therapy and occupational therapy programs prescribed individually for each child based on the functional capacity of each child (each program lasted for 30 minutes). Additionally, a 30- minute rest period will be implemented before receiving the allocated intervention. This group will receive a plyometric training program for 45 minutes The treatment will be implemented three sessions a week for three months period.
Intervention Type
Other
Intervention Name(s)
Designed physical therapy
Intervention Description
Attention was given to improve strength, enhance postural control, promote normal walking-pattern, and optimize function. The program incorporated manual passive and functional flexibility, progressive strengthening, postural and advanced balance exercises, and functional walking exercises
Intervention Type
Other
Intervention Name(s)
Occupational therapy
Intervention Description
Both groups received a designed occupational therapy program for 30 minutes that included exercises facilitating hand skills, such as reaching, grasping, carrying, releasing, in-hand manipulation, and bilateral hand use. The children performed these exercises while they sat on a chair, with the therapist sitting beside to guide and assist them in performing the exercises correctly
Intervention Type
Other
Intervention Name(s)
Plyometric training
Intervention Description
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. The exercise load is progressively increased and conducted in two phases; each phase lasted for six weeks. To ensure safety and optimal performance, every child performed a pre-workout warming up before each session for five minutes including static and dynamic stretching and moving through the exercises planned for each day's workout at a lower intensity. Another set of cool down exercises for five minutes is considered to stretch and relax the entire body after each session. The exercises include: Two-hand chest pass Downward slam throw Push-ups against wall Clap push-ups against wall Bench push-ups Two-hand overhead throw Two-hand underhand side throw Single-Arm Throw
Intervention Type
Other
Intervention Name(s)
Wii training
Intervention Description
The dose of Wii training was 40 minutes, three times a week for 12 weeks which is an interactive motion-based device. The Wii has a multiplayer mode and different levels of difficulty. The content of Wii training consisted of practicing four Wii games: (1) tennis; (2) boxing; (3) bowling; and (4) basketball. These games are chosen because they target the upper limbs, are fun, provide immediate feedback, and are easy to learn and play, and progression is built into the game. Also, fine motor coordination and sensory deficits are targeted through pressing buttons and vibration feedback from the Wii Remote. The children are instructed that they could stop at any point if discomfort or undue fatigue is experienced. The therapist randomly presented the games to eliminate any effect of order
Primary Outcome Measure Information:
Title
Upper extremity function
Description
The quality of upper extremity skill test is a reliable and valid tool used to measure the motor function in children with cerebral palsy ages of 18 months to 8 years in four basic domains representing dissociated movement; grasp; protective extension; and weight bearing. The total scores for each domain percentage score are calculated as total score which range from zero to 100% with higher score reflects better performance.
Time Frame
after 3 months of treatment
Title
Hand grip strength
Description
The hand held dynamometer (Patterson Medical, Warrenville, IL, USA) is a valid and reliable tool to assess grip strength in typically developing and disabled children recorded in kilogram. The assessment will be carried out with the child sitting on a chair with back support with suitable height to maintain the hips and knees at right angles and feet maintained on the supporting surface in neutral position. The tested upper extremity is aligned beside the body forearm and wrist in neutral positions with 90o elbow flexion. Then, each child is instructed to maximally compress the handle of the dynamometer. Each child performs three trials and the mean will be recorded in kilogram for statistical analysis.
Time Frame
after 3 months of treatment
Secondary Outcome Measure Information:
Title
Range of motion
Description
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
Time Frame
after 3 months of treatment
Title
Selective motor control
Description
Test of arm selective control, a valid and reliable tool, will be used to measure selectivity of upper extremity of shoulder; elbow; wrist; fingers movements and thumb extension (key grip) as described in in the illustrated guide for administration and scoring. For each movement, the examiner passively moves the tested upper extremity to assess the full range of motion and demonstrate the desired movement. Then, he/she is instructed to actively move the test upper extremity using a three-second verbal count. Each position is scored as unable (0); impaired (1) or intact SVMC (2) with total score for each upper extremity is 16 and 32 for both tested upper extremities.
Time Frame
after 3 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 8-12 years; both sexes; had a diagnosis of spastic hemiplegia obtained from medical records; level I-III on the Manual Ability Classification System (MACS) able to understand and follow simple commands. Exclusion Criteria: Botox injection/surgery in the affected upper extremity within the past 6 months; severe uncontrolled seizures; fixed deformities in the affected side attention deficit disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira M Abd-elmonem, PhD
Phone
01155553316
Email
Dramira.salim2020@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amira M Abd-elmonem, PhD
Phone
01155553316
Email
amira.mahmoud@cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
walaa A El-nabie, Phd
Organizational Affiliation
Cairo university, faculty of physical therapy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hazem A Ali, Phd
Organizational Affiliation
Cairo university, faculty of physical therapy
Official's Role
Study Director
Facility Information:
Facility Name
faculty of physical therapy, Cairo university
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amira M Abd-elmonem
Email
Dramira.salim2020@gmail.com

12. IPD Sharing Statement

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Plyometric Exercises Versus Wii Training In Children With Unilateral Cerebral Palsy

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