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Clinical Trials/NCT05312125
NCT05312125
Completed
Not Applicable

Comparison of the Effectiveness of Different Physiotherapy and Rehabilitation Programs After Onabotulinum Toxin-A Injection and Serial Casting in Children With Cerebral Palsy

Gazi University1 site in 1 country19 target enrollmentApril 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Gazi University
Enrollment
19
Locations
1
Primary Endpoint
Muscle strenght
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The effects of different physiotherapy programs on children with cerebral palsy who have been received botulinum toxin injection and serial casting application will be determined.

Detailed Description

CP children who underwent botulinum toxin injection to medial gastrocnemius muscle and serial casting application in last two months will be included in the study. The effects of traditional physiotherapy and downhill backward treadmill training plus to traditional physiotherapy on muscle morphology, activity, walking, quality of life and selectivity will be determined.

Registry
clinicaltrials.gov
Start Date
April 6, 2022
End Date
April 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

pelin atalan

Physiotherapist, MSc

Gazi University

Eligibility Criteria

Inclusion Criteria

  • Being diagnosed with cerebral palsy (CP) (hemiplegic-diplegic)
  • To have undergone botulinum toxin and serial casting interventions in the last 2 months
  • to be between 5-10 years old
  • Being at the level of I-II-III (ambulatory or assisted ambulatory) according to Gross Motor Function Classification System
  • To have the mental competence to understand and apply assessments and exercises

Exclusion Criteria

  • Having undergone surgery involving the lower extremity in the last 6 months
  • Refusing to participate in the study
  • Having other accompanying neurometabolic or orthopedic disorders

Outcomes

Primary Outcomes

Muscle strenght

Time Frame: After six weeks intervention

Will be measured by manual muscle tester

Muscle morphology

Time Frame: After six weeks intervention

Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements

Vascularization

Time Frame: After six weeks intervention

Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements

Range of motion

Time Frame: After six weeks intervention

Will be measured with goniometer

Modified Tardieu Scale

Time Frame: After six weeks intervention

Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity

Edinburgh visual gait analysis

Time Frame: After six weeks intervention

Gait will be recorded as video and this video will be scored

Secondary Outcomes

  • Lower extremity selective control measurement(After six weeks intervention)
  • Child Health Questionnare (Parent form)(After six weeks intervention)
  • Children Functional Independence Measurement Scale(After six weeks intervention)
  • Demographic data(After six weeks intervention)

Study Sites (1)

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