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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05313633
Other study ID # plyometric training
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date March 30, 2023

Study information

Verified date December 2022
Source Cairo University
Contact Amira M Abd-elmonem, PhD
Phone 01155553316
Email Dramira.salim2020@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date March 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 8 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Designed physical therapy
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
Occupational therapy
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
Plyometric training
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
Wii training
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

Locations

Country Name City State
Egypt faculty of physical therapy, Cairo university Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. after 3 months of treatment
Primary 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. after 3 months of treatment
Secondary 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
after 3 months of treatment
Secondary 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. after 3 months of treatment
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