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Completed

NCT Number: NCT05198999

Aquatic-based Explosive Strength Training in Children With Cerebral Palsy

This study was designed to assess the effect of a 12-week aquatic-based plyometric (Aqua-PLYO) training on postural control and functional performance in children with hemiparetic cerebral palsy (h-CP). Fifty-six children with h-CP were randomly allocated to the Aqua-PLYO group (n = 28, received an Aqua-PLYO training program, trice/week, over 12 weeks) or the control group (n =28, received standard rehabilitation). Both groups were assessed for postural control and functional performance pre and post-treatment.

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Key information

Conditions

Cerebral Palsy Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Motor Activity Nervous System Diseases

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aquatic-based Plyometric Exercises

Other

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

Standard physical therapy

Other

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.

Primary outcomes

  1. Directional Control

    Time frame: 2 months

    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. Reaction time

    Time frame: 2 months

    The time, taken by an individual to start shifting his center of gravity from the static position after the cue, measured in seconds

  3. Movement Velocity

    Time frame: 2 months

    The average speed at which the center of gravity shifts, measured in degree/second

  4. EndPoint Excursion

    Time frame: 2 months

    The distance willingly covered by the subject in his very first attempt towards the target, expressed as a percentage (%)

  5. Maximum Excursion

    Time frame: 2 months

    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

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Aquatic-based Plyometric Exercises for Children With Hemiparetic Cerebral Palsy: A Randomized Controlled Study Investigating Effects on Postural Control and Functional Performance

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 20, 2022
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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