NCT06980246

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 12, 2025

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle strength

    The peak isometric muscle strength (Kg) was measured using a hand-held dynamometer

    2 months

Secondary Outcomes (5)

  • Unilateral upper-extremity function

    2 months

  • Spontaneity of the upper extremity use

    2 months

  • Dynamic positional alignment of the upper extremity

    2 months

  • Grasp-release Ability

    2 months

  • Bimanual hand function

    2 months

Study Arms (2)

Plyo-Ex group

EXPERIMENTAL

Children in this group received the Plyo-Ex program

Other: Plyometric Exercise

Control group

ACTIVE COMPARATOR

Children in this group received the standard exercise program.

Other: Standard exercise program

Interventions

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.

Plyo-Ex group

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.

Control group

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

Related Publications (1)

  • Elnaggar RK, Ramirez-Campillo R, Elfakharany MS, Alrawaili SM, Alghadier M, Alotaibi MA, El-Basatiny HM, Elsaeed TM. Task-Oriented Plyometric Intervention for Augmenting Upper Extremity Strength and Function in Hemiparetic Cerebral Palsy: A Randomized Controlled Trial. NeuroRehabilitation. 2025 Dec 24:10538135251400762. doi: 10.1177/10538135251400762. Online ahead of print.

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ragab K Elnaggar, PhD

    Prince Sattam Bin Abdulaziz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, two-arm, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 20, 2025

Study Start

February 12, 2023

Primary Completion

January 4, 2024

Study Completion

January 4, 2024

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations