Comparison of the Effectiveness of Different Physiotherapy and Rehabilitation Programs After Onabotulinum Toxin-A Injection and Serial Casting in Children With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gazi University
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Muscle strenght
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
control group
Children in this group will take routine physiotherapy (stretching, strengthening) program during 6 weeks. 3 days/week.
Intervention: routine physiotherapy (Procedure)
intervention group
Children in this group will take routine physiotherapy (stretching, strengthening) program + backward downhill walking (10 minutes in a day) during 6 weeks. 3 days/week.
Intervention: backward downhill walking (Procedure)
intervention group
Children in this group will take routine physiotherapy (stretching, strengthening) program + backward downhill walking (10 minutes in a day) during 6 weeks. 3 days/week.
Intervention: routine physiotherapy (Procedure)
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
Muscle morphology
Time Frame: Before the intervention
Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements
Vascularization
Time Frame: Before the the intervention
Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements
Muscle strenght
Time Frame: Before the intervention
Will be measured by manual muscle tester
Range of motion
Time Frame: Before the intervention.
Will be measured with goniometer
Edinburgh visual gait analysis
Time Frame: Before the intervention
Gait will be recorded as video and this video will be scored
Modified Tardieu Scale
Time Frame: Before the intervention
Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity
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)
- Demographic data(Before the intervention)
- Child Health Questionnare (Parent form)(Before the intervention)
- Children Functional Independence Measurement Scale(Before the intervention)
- Lower extremity selective control measurement(Before the intervention)
Investigators
pelin atalan
Physiotherapist, MSc
Gazi University