NCT05198999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

December 19, 2021

Last Update Submit

January 5, 2022

Conditions

Keywords

Unilateral Cerebral PalsyBalanceRehabilitationExerciseFunctionActivityParticipation

Outcome Measures

Primary Outcomes (8)

  • Directional Control

    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

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

    2 months

  • Movement Velocity

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

    2 months

  • EndPoint Excursion

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

    2 months

  • Maximum Excursion

    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

    2 months

  • Functional lower limb strength

    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

    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

    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

Study Arms (2)

Aqua-PLYO group

EXPERIMENTAL

Participants in this group received the Aqua-PLYO training program

Other: Aquatic-based Plyometric Exercises

Control group

ACTIVE COMPARATOR

Participants in this group received the standard physical rehabilitation program

Other: Standard Physical Therapy

Interventions

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

Aqua-PLYO group

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.

Control group

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • Ragab K Elnaggar, PhD

    Prince Sattam Bin Abdulaziz University

    PRINCIPAL INVESTIGATOR
  • Ragab K Elnaggar, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective pre-test post-test randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 19, 2021

First Posted

January 20, 2022

Study Start

August 6, 2018

Primary Completion

September 26, 2019

Study Completion

September 26, 2019

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations