Strength Training in Children With Cerebral Palsy

NCT ID: NCT04892576

Last Updated: 2021-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-28

Study Completion Date

2019-11-06

Brief Summary

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This study was set out to assess the effect of stretch-shortening (SSC) exercises on gait-symmetry and balance in children with unilateral cerebral palsy (UCP). Forty-two children with UCP were randomly allocated to the control group (n = 21, received standard physical rehabilitation) or the SSC group (n =21, received standard rehabilitation plus SSC exercises). Both groups were assessed for ait-symmetry and balance pre and post-treatment.

Detailed Description

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Forty-two children with UCP were recruited from the Physical Therapy Outpatient Clinic of Collee 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 8 and 12 years, were functioning at levels I or II according to 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, 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. Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through a 3D motion analysis system.
2. Balance capabilities: several aspects of balance including sensory organization, reactive balance, and rhythmic weight shift were tested through a Pro Balance Master system.

The control and SSC groups received a standard rehabilitation program for 45 minutes, twice a week for eight consecutive weeks. The program comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises. Additionally, the SSC group received an SSC exercise program for 30 minutes, twice/week for eight weeks per the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The SSC program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities. The SSC training was preceded by a warm-up for 5 minutes and ended up with a 5-min cooldown.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective pre-test post-test randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment

Study Groups

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Control group

Participants in this group received the standard physical rehabilitation program.

Group Type ACTIVE_COMPARATOR

Physical Therapy

Intervention Type OTHER

The control group recieved the standard physical rehabilitation program conducted for 45 minutes, twice a week for eight consecutive weeks, and consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises.

The SSC group received the same program in addition to the SSC exercises for 30 minutes, two times per week for eight successive weeks

SSC group

Participants in this group received the standard physical rehabilitation program as the control group in addition to the SSC exercise program

Group Type EXPERIMENTAL

Physical Therapy

Intervention Type OTHER

The control group recieved the standard physical rehabilitation program conducted for 45 minutes, twice a week for eight consecutive weeks, and consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises.

The SSC group received the same program in addition to the SSC exercises for 30 minutes, two times per week for eight successive weeks

Interventions

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Physical Therapy

The control group recieved the standard physical rehabilitation program conducted for 45 minutes, twice a week for eight consecutive weeks, and consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises.

The SSC group received the same program in addition to the SSC exercises for 30 minutes, two times per week for eight successive weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Unilateral cerebral palsy
* age from 8 to 12 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

Exclusion Criteria

* Structural deformities
* Musculoskeletal or neural surgery in the last year
* BOTOX injection in the last 6 months.
* cardiopulmonary disorders interfering with the ability to engage in exercise training
* hemispatial neglect
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ragab Kamal Elnaggar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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RHPT/0018/0078

Identifier Type: -

Identifier Source: org_study_id

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