NCT05429281

Brief Summary

This study was conducted to compare the effect of Pilates-based core strengthening (PsCS) and plyometric-based muscle loading (PlyoML) and their combination on postural control, balance, and mobility in children with unilateral cerebral palsy (ULCP). Eighty-one children with ULCP were randomly allocated to the PsCS (n = 27), PlyoML (n = 27), or combined intervention (n = 27) group. Participants in the three groups were assessed for postural control, balance, and mobility on the pre and post-treatment occasions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

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 7, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

June 18, 2022

Last Update Submit

June 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Limit of postural stability

    The capacity to control and move the center of gravity in various directions across their base of support was assessed utilizing the Biodex balance system. Values are expressed as accuracy % and higher scores mean better balance capability.

    2 months

Secondary Outcomes (3)

  • Community Balance and Mobility Scale

    2 months

  • Functional Walking Test

    2 months

  • Timed Up and Down Stair test

    2 months

Study Arms (3)

Pilates-based Core Strengthening Group

ACTIVE COMPARATOR

Participants in this group performed eight PsCS exercises geared predominantly to the core muscles.

Other: Pilates-based Core Strengthening Exercises

Plyometric-based Muscle Loading Group

ACTIVE COMPARATOR

Participants in this group performed 10 PlyoML exercises primarily focused on the lower body.

Other: Plyometric-based Muscle Loading Exercises

Combined training group

EXPERIMENTAL

Participants in this group performed the same exercises as the PsCS and PlyoML groups, although with half the number of sets/repetitions.

Other: Combined Pilates and Plyometrics

Interventions

The PsCS group performed eight Pilates exercises over 45 minutes, three times per week for 12 successive weeks. The training was conducted under the supervision of a physical therapist who had more than 5 years of experience in Pilates.

Pilates-based Core Strengthening Group

The PlyoML group performed 10 plyometric exercises over 45 minutes, three times per week for 12 successive weeks. The training was conducted under the close supervision of a licensed pediatric physical therapist. The safety and performance guidelines, defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association, were considered during training.

Plyometric-based Muscle Loading Group

The combined training group performed the same exercises as the PsCS and PlyoML groups, although with half the number of sets/repetitions over 45 minutes, three times per week for 12 successive weeks. The PsCS and PlyoML were executed within the same session, with a 10-to-15-minute rest interval. The training was conducted under the close supervision of a licensed pediatric physical therapist. The safety and performance guidelines, defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association, were considered during training.

Combined training group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Unilateral cerebral palsy
  • Age 12-18 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 interfere with the ability to engage in exercise training.
  • 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

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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 blinded to the treatment allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, assessor-blinded, randomized study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 18, 2022

First Posted

June 23, 2022

Study Start

February 7, 2021

Primary Completion

April 28, 2022

Study Completion

April 28, 2022

Last Updated

June 23, 2022

Record last verified: 2022-06

Locations