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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04892576
Other study ID # RHPT/0018/0078
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 28, 2018
Est. completion date November 6, 2019

Study information

Verified date May 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date November 6, 2019
Est. primary completion date November 6, 2019
Accepts healthy volunteers No
Gender All
Age group 8 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
Saudi Arabia Ragab K. Elnaggar Al Kharj Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gait symmetry Gait symmetry indices (spatial and temporal) were measured about the step length and single-limb support time of the paretic and non-paretic leg through a 3D motion analysis system 2 months
Primary Balance Capabilities Some aspects of balance capabilities including sensory organization, reactive balance, and rhythmic weight shift were measured through a Pro Balance Master sytem. 2 months
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