Clinical trial NCT05312125: Physiotherapy After Botulinum Toxin Injection and Serial Casting
Official title: Comparison of the Effectiveness of Different Physiotherapy and Rehabilitation Programs After Onabotulinum Toxin-A Injection and Serial Casting in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Cerebral Palsy, Spastic
Keywords: cerebral palsy
botulinum toxin
serial casting
physiotherapy
muscle morphology
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Gulhane Training and Research Hospital
name: Ankara Eğitim ve Araştırma Hastanesi
First posted: 2022-04-05
Enrollment: 19
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of children with Cerebral palsy are going to be involved at the same time. One of the groups will be enrolled in the routine physiotherapy intervention. The other group will be enrolled to the routine physiotherapy intervention + backward downhill walking.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Muscle morphology
timeFrame: Before the intervention
measure: Muscle morphology
timeFrame: After six weeks intervention
measure: Vascularization
timeFrame: Before the the intervention
measure: Vascularization
timeFrame: After six weeks intervention
measure: Muscle strenght
timeFrame: Before the intervention
measure: Muscle strenght
timeFrame: After six weeks intervention
measure: Range of motion
timeFrame: Before the intervention.
measure: Range of motion
timeFrame: After six weeks intervention
measure: Edinburgh visual gait analysis
timeFrame: Before the intervention
measure: Edinburgh visual gait analysis
timeFrame: After six weeks intervention
measure: Modified Tardieu Scale
timeFrame: Before the intervention
measure: Modified Tardieu Scale
timeFrame: After six weeks intervention
Secondary outcomes:
measure: Demographic data
timeFrame: Before the intervention
measure: Demographic data
timeFrame: After six weeks intervention
measure: Child Health Questionnare (Parent form)
timeFrame: Before the intervention
measure: Child Health Questionnare (Parent form)
timeFrame: After six weeks intervention
measure: Children Functional Independence Measurement Scale
timeFrame: Before the intervention
measure: Children Functional Independence Measurement Scale
timeFrame: After six weeks intervention
measure: Lower extremity selective control measurement
timeFrame: Before the intervention
measure: Lower extremity selective control measurement
timeFrame: After six weeks intervention
Other outcomes:
Locations:
city: İ̇zmi̇r
country: Turkey
facility: Pelin Atalan
state: Bornova
Study officials:
References: