NCT04892576

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

October 28, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

May 14, 2021

Last Update Submit

May 14, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Control group

ACTIVE COMPARATOR

Participants in this group received the standard physical rehabilitation program.

Other: Physical Therapy

SSC group

EXPERIMENTAL

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

Other: Physical Therapy

Interventions

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

Control groupSSC group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

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 Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

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
Assistant Professor

Study Record Dates

First Submitted

May 14, 2021

First Posted

May 19, 2021

Study Start

October 28, 2018

Primary Completion

November 6, 2019

Study Completion

November 6, 2019

Last Updated

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations