- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05429281
The Role of Pilates, Plyometrics, and Their Combination for Children With Unilateral Cerebral Palsy
Comparative Efficacy of Pilates-Based Core Strengthening, Plyometric-Based Muscle Loading, and Their Combination on Postural Control, Balance, and Mobility in Children With Unilateral Cerebral Palsy
Study Overview
Status
Conditions
Detailed Description
Eighty-one children with ULCP were recruited from the Physical Therapy Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 12 and 18 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, and if they had cardiopulmonary problems preventing them from performing high-intense exercise training.
Outcome measures
- Postural control: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.
- Balance and mobility: The Community Balance and Mobility Scale (CB&M), Functional Walking Test (FWT), and Timed Up and Down Stair test (TUDS) were used to quantify balance and mobility capacity.
Interventions
All groups were trained for 45 minutes, twice per week, for 12 successive weeks. The PsCS group performed eight Pilates exercises geared predominantly toward the core muscles. The PlyoML group performed 10 plyometric exercises primarily focused predominantly on the lower body. The combined group combined the same exercises as the PsCS and PlyoML groups, although with half the number of sets/repetitions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Riyadh
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Al Kharj, Riyadh, Saudi Arabia
- Ragab K. Elnaggar
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Pilates-based Core Strengthening Group
Participants in this group performed eight PsCS exercises geared predominantly to the core muscles.
|
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.
|
|
ACTIVE_COMPARATOR: Plyometric-based Muscle Loading Group
Participants in this group performed 10 PlyoML exercises primarily focused on the lower body.
|
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.
|
|
EXPERIMENTAL: Combined training group
Participants in this group performed the same exercises as the PsCS and PlyoML groups, although with half the number of sets/repetitions.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Limit of postural stability
Time Frame: 2 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Community Balance and Mobility Scale
Time Frame: 2 months
|
Community Balance and Mobility Scale is a performance-based measure assessing high-level balance capabilities while also addressing the speed and coordination components necessary for the ordinary community function. The scale consists of 13 items. Item scores range from zero (complete inability of task execution) to five (the most successful task completion), and the maximum possible score is 96. A higher score indicates better performance. |
2 months
|
|
Functional Walking Test
Time Frame: 2 months
|
The Functional Walking Test is a valid and reliable measure for assessing functional waking capacity in ambulant children with cerebral palsy.
The test consists of 11 items including kneel walking, transitions to standing, incline walking, ascending/descending stairs, and walking a narrow beam, all of which focus on the postural control and balance components of walking.
The maximum score is 23 and higher scores indicate better walking capacity
|
2 months
|
|
Timed Up and Down Stair test
Time Frame: 2 months
|
The Timed Up and Down Stairs test measures the time (in seconds) that the children take to go up a 14-step stair flight (each step was 20 cm in height), turn around, and come back down.
Shorter time indicates better performance.
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHPT/0021/0114
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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