The Role of Pilates, Plyometrics, and Their Combination for Children With Unilateral Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Pilates-based Core Strengthening Exercises
Plyometric-based Muscle Loading Exercises
Combined Pilates and Plyometrics
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
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.
Sites / Locations
- Ragab K. Elnaggar
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Pilates-based Core Strengthening Group
Plyometric-based Muscle Loading Group
Combined training group
Arm Description
Participants in this group performed eight PsCS exercises geared predominantly to the core muscles.
Participants in this group performed 10 PlyoML exercises primarily focused on the lower body.
Participants in this group performed the same exercises as the PsCS and PlyoML groups, although with half the number of sets/repetitions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Community Balance and Mobility Scale
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.
Functional Walking Test
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
Timed Up and Down Stair test
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05429281
Brief Title
The Role of Pilates, Plyometrics, and Their Combination for Children With Unilateral Cerebral Palsy
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 7, 2021 (Actual)
Primary Completion Date
April 28, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, assessor-blinded, randomized study
Masking
Outcomes Assessor
Masking Description
This was a single-blind protocol. The researcher who collected the data was blinded to the treatment allocation
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilates-based Core Strengthening Group
Arm Type
Active Comparator
Arm Description
Participants in this group performed eight PsCS exercises geared predominantly to the core muscles.
Arm Title
Plyometric-based Muscle Loading Group
Arm Type
Active Comparator
Arm Description
Participants in this group performed 10 PlyoML exercises primarily focused on the lower body.
Arm Title
Combined training group
Arm Type
Experimental
Arm Description
Participants in this group performed the same exercises as the PsCS and PlyoML groups, although with half the number of sets/repetitions.
Intervention Type
Other
Intervention Name(s)
Pilates-based Core Strengthening Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Plyometric-based Muscle Loading Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Combined Pilates and Plyometrics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Limit of postural stability
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Community Balance and Mobility Scale
Description
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.
Time Frame
2 months
Title
Functional Walking Test
Description
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
Time Frame
2 months
Title
Timed Up and Down Stair test
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragab K Elnaggar, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ragab K. Elnaggar
City
Al Kharj
State/Province
Riyadh
Country
Saudi Arabia
12. IPD Sharing Statement
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The Role of Pilates, Plyometrics, and Their Combination for Children With Unilateral Cerebral Palsy
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