Cerebral PalsyNCT05429281
The Role of Pilates, Plyometrics, and Their Combination for Children With Unilateral Cerebral Palsy
A study testing Pilates-based Core Strengthening Exercises, Plyometric-based Muscle Loading Exercises and Combined Pilates and Plyometrics in people with Cerebral Palsy, run by Cairo University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Pilates-based Core Strengthening Exercises, Plyometric-based Muscle Loading Exercises and Combined Pilates and Plyometrics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 7 Feb 2021to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Pilates-based Core Strengthening Exercises, Plyometric-based Muscle Loading Exercises, Combined Pilates and Plyometrics
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates-based Core Strengthening ExercisesOther
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.
Plyometric-based Muscle Loading ExercisesOther
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.
Combined Pilates and PlyometricsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates-based Core Strengthening Group | Active comparator | Participants in this group performed eight PsCS exercises geared predominantly to the core muscles. Receives: 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. Receives: 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. Receives: Other: Combined Pilates and Plyometrics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (3)
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.
Measured: 2 months
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
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start7 Feb 2021
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, assessor-blinded, randomized study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
- Investigators
- Ragab K Elnaggar, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429281
- Sponsor's protocol ID
- RHPT/0021/0114
- Status last verified
- Jun 2022
- First submitted
- 18 Jun 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05429281
- Acronym / sponsor ID
- RHPT/0021/0114
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Feb 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, assessor-blinded, randomized study
| Arm | Type | Receives |
|---|---|---|
| Pilates-based Core Strengthening Group | Active comparator | Other: Pilates-based Core Strengthening ExercisesParticipants in this group performed eight PsCS exercises geared predominantly to the core muscles. |
| Plyometric-based Muscle Loading Group | Active comparator | Other: Plyometric-based Muscle Loading ExercisesParticipants in this group performed 10 PlyoML exercises primarily focused on the lower body. |
| Combined training group | Experimental | Other: Combined Pilates and PlyometricsParticipants in this group performed the same exercises as the PsCS and PlyoML groups, although with half the number of sets/repetitions. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates-based Core Strengthening ExercisesThe 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. | Other | Pilates-based Core Strengthening Group |
| Plyometric-based Muscle Loading ExercisesThe 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. | Other | Plyometric-based Muscle Loading Group |
| Combined Pilates and PlyometricsThe 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. | Other | Combined training group |
Primary outcome
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.
3 secondary outcomes
Community Balance and Mobility Scale
Time frame: 2 months
Functional Walking Test
Time frame: 2 months
Timed Up and Down Stair test
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragab K Elnaggar, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates-based Core Strengthening Exercises, Plyometric-based Muscle Loading Exercises and Combined Pilates and Plyometrics in people with Cerebral Palsy, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limit of postural stability (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.