Clinical trial NCT05198999: Aquatic-based Explosive Strength Training in Children With Cerebral Palsy
Official title: Aquatic-based Plyometric Exercises for Children With Hemiparetic Cerebral Palsy: A Randomized Controlled Study Investigating Effects on Postural Control and Functional Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Unilateral Cerebral Palsy
Balance
Rehabilitation
Exercise
Function
Activity
Participation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 56
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective pre-test post-test randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

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

1. Postural control: The dynamic limits of stability (LOSdynamic) indices were measured through the Balance Master system.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Directional Control
timeFrame: 2 months
measure: Reaction time
timeFrame: 2 months
measure: Movement Velocity
timeFrame: 2 months
measure: EndPoint Excursion
timeFrame: 2 months
measure: Maximum Excursion
timeFrame: 2 months
measure: Functional lower limb strength
timeFrame: 2 months
measure: Functional mobility
timeFrame: 2 months
measure: Gait balance
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Ragab K. Elnaggar
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Ragab K Elnaggar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Ragab K Elnaggar, PhD
role: PRINCIPAL_INVESTIGATOR
References: