- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05198999
Aquatic-based Explosive Strength Training in Children With Cerebral Palsy
Aquatic-based Plyometric Exercises for Children With Hemiparetic Cerebral Palsy: A Randomized Controlled Study Investigating Effects on Postural Control and Functional Performance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Fifty-six children with h-CP 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 16 years, were functioning at levels I or II on the Gross Motor Function Classification System, and had spasticity level 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, had leg-length discrepancy, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, attentional neglect, cardiopulmonary problems preventing them from performing high-intense exercise training.
Outcome measures
- Postural control: The dynamic limits of stability (LOSdynamic) indices were measured through the Balance Master system.
- Functional performance: Functional performance was quantified using the 30-second sit-to-stand test (30sec-STS), Timed Up and Down Stairs test (TUDS), and the Dynamic Gait Index (DGI).
The Aqua-PLYO group received a 12-week Aqua-PLYO training, 45 minutes per session, three times a week for 12 consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The Aqua-PLYO program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities conducted in a water medium. The Aqua-PLYO training included a warm-up for 10 minutes and a cool-down for10 minutes. The control group received the usual physical therapy care, 45 minutes per session, three times a week for 12 consecutive weeks. The program consisted of advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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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:
- Hemiparetic cerebral palsy
- Age between 12 to 16 years
- Spasticity level 1 or 1+ according to the Modified Ashworth Scale
- Gross motor function level I or II according to the Gross Motor Function Classification System
Exclusion Criteria:
- Structural deformities
- Musculoskeletal or neural surgery in the last year
- BOTOX injection in the last 6 months.
- Cardiopulmonary disorders limit the ability to engage in explosive exercise training
- Hemi-spatial neglect
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
Participants in this group received the standard physical rehabilitation program
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The control group received the standard physical rehabilitation program conducted for 45 minutes, thrice a week for 12 consecutive weeks, and consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises.
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Experimental: Aqua-PLYO group
Participants in this group received the Aqua-PLYO training program
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The Aqua-PLYO group received the aquatic plyometric exercise training for 45 minutes, three times per week for 12 successive weeks.
The training was conducted under close supervision of a licensed pediatric physical therapist according to safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Directional Control
Time Frame: 2 months
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The amount of movement demonstrated in the desired direction, i.e. towards the target, to the amount of external movement in the opposite direction of the target, expressed as a percentage.
|
2 months
|
Reaction time
Time Frame: 2 months
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The time, taken by an individual to start shifting his center of gravity from the static position after the cue, measured in seconds
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2 months
|
Movement Velocity
Time Frame: 2 months
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The average speed at which the center of gravity shifts, measured in degree/second
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2 months
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EndPoint Excursion
Time Frame: 2 months
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The distance willingly covered by the subject in his very first attempt towards the target, expressed as a percentage (%)
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2 months
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Maximum Excursion
Time Frame: 2 months
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The distance, the subject actually covered or moved his center of gravity toward a target, expressed as a percentage (%) of the dynamic limit of stability
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2 months
|
Functional lower limb strength
Time Frame: 2 months
|
the functional strength of lower limbs was measured by the 30-second sit-to-stand test.
The test determines the number of sit-to-stand task repetitions performed within 30 seconds.
The higher number of repetitions indicates better performance.
|
2 months
|
Functional mobility
Time Frame: 2 months
|
Functional mobility was assessed by Timed Up and Down Stairs test.
the test measures the time (second) that the subject takes to go upstairs, turn around, and come back down.
Shorter time indicates better performance.
|
2 months
|
Gait balance
Time Frame: 2 months
|
Gait balance was measured by the Dynamic Gait Index. The dynamic gait index quantified the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. The index includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent. Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score is 24. Higher scores mean a better outcome. |
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ragab K Elnaggar, PhD, Cairo University
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/0018/0069
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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