Utility of Upper-Extremity Plyometrics in Children With Unilateral Cerebral Palsy

NCT ID: NCT06980246

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-12

Study Completion Date

2024-01-04

Brief Summary

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This study was set out to evaluate the effect of a 12-week upper extremity plyometric exercise (Plyo-Ex) on muscle strength and upper extremity function in children with hemiparetic cerebral palsy (Hemi-CP). Fifty-eight children with Hemi-CP were randomly allocated to the Plyo-Ex group (n = 29, received Plyo-Ex program, twice/week, over 12 weeks) or the control group (n = 29, received standard exercise program). Both groups were assessed for muscle strength and upper extremity function before and after treatment.

Detailed Description

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Fifty-eight children with Hemi-CP were recruited from the Physical Therapy Outpatient Clinic of Prince Sattam Bin Abdulaziz University and three referral hospitals in Riyadh provenience, Saudi Arabia. Their age ranged between 10 and 15 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity levels 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, had attentional neglect, demonstrated any cognitive issues, and if they had cardiopulmonary problems that could be exacerbated by exercise.

Outcome measures

Muscle strength: The peak isometric muscle strength of the shoulder flexors, abductors, external rotators, elbow extensors, and wrist extensors was measured using a hand-held dynamometer.

Unilateral upper-extremity function : The unimanual functional performance was assessed using Melbourne Assessment (MA).

Bimanual hand function:The biimanual functional performance was evaluated utilizing the Assisting Hand Assessment (AHA)

The Plyo-Ex group received a 12-week therapist-led Plyo-Ex training, for approximately 45 minutes per session, two times a week for 12 consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The Plyo-Ex program consisted of ten unilateral and bilateral upper extremity exercises in the form of push-ups and ball slams/throws/passes activities. The Plyo-Ex program preceded with a warm-up for 5 minutes and ended with a cool-down for 5 minutes. The control group received the standard exercise program, 45 minutes per session, two times a week for 12 consecutive weeks. The program consisted of flexibility exercises, strength training, weight-bearing exercises, proprioceptive neuromuscular facilitation, coordination exercise, task-oriented training, and functional exercises.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, two-arm, randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment

Study Groups

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Plyo-Ex group

Children in this group received the Plyo-Ex program

Group Type EXPERIMENTAL

Plyometric Exercise

Intervention Type OTHER

The Plyo-Ex program was conducted for 45 minutes/session twice weekly over 12 weeks. The program was directed by a pediatric physical therapist in accordance with the safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association. The program consisted of ten unilateral and bilateral upper extremity exercises in the form of push-ups and ball slams/throws/passes activities and was preceded by a warm-up for 5 minutes and ended with a cool-down for 5 minutes.

Control group

Children in this group received the standard exercise program.

Group Type ACTIVE_COMPARATOR

Standard exercise program

Intervention Type OTHER

The standard exercise program lasted for 45 minutes/session and repeated two times a week for 12 consecutive weeks. The program was conducted by a pediatric physical therapist and consisted of flexibility exercises, strength training, weight-bearing exercises, proprioceptive neuromuscular facilitation, coordination exercise, and functional training.

Interventions

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Plyometric Exercise

The Plyo-Ex program was conducted for 45 minutes/session twice weekly over 12 weeks. The program was directed by a pediatric physical therapist in accordance with the safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association. The program consisted of ten unilateral and bilateral upper extremity exercises in the form of push-ups and ball slams/throws/passes activities and was preceded by a warm-up for 5 minutes and ended with a cool-down for 5 minutes.

Intervention Type OTHER

Standard exercise program

The standard exercise program lasted for 45 minutes/session and repeated two times a week for 12 consecutive weeks. The program was conducted by a pediatric physical therapist and consisted of flexibility exercises, strength training, weight-bearing exercises, proprioceptive neuromuscular facilitation, coordination exercise, and functional training.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Unilateral cerebral palsy
* Age 10-15 years
* Motor function level I or II according to the Gross Motor Function Classification System.
* Spasticity level 1 or 1+ according to the Modified Ashworth Scale

Exclusion Criteria

* Structural deformities/contractures
* Musculoskeletal or neural surgery in the last year
* BOTOX injection in the last 6 months.
* Cardiopulmonary disorders that could be exacerbated by exercise.
* Perceptual and/or behavioral disorders.
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ragab Kamal Elnaggar

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ragab K Elnaggar, PhD

Role: PRINCIPAL_INVESTIGATOR

Prince Sattam Bin Abdulaziz University

Locations

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Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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RHPT/0023/0013

Identifier Type: -

Identifier Source: org_study_id

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