Physiotherapy After Botulinum Toxin Injection and Serial Casting

Not Applicable

Completed

• Conditions: Cerebral Palsy; Cerebral Palsy, Spastic
• Interventions: Procedure: routine physiotherapy; Procedure: backward downhill walking

• Registration Number: NCT05312125
• Lead Sponsor: Gazi University

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 Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-04-05
• Study Start: 2022-04-06
• Primary Completion: 2022-12-20
• Study Completion: 2023-04-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	routine physiotherapy	Children in this group will take routine physiotherapy (stretching, strengthening) program during 6 weeks. 3 days/week.
intervention group	routine physiotherapy	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 group	backward downhill walking	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.

Primary Outcome Measures

Name	Time	Method
Muscle morphology	After six weeks intervention	Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements
Muscle strenght	After six weeks intervention	Will be measured by manual muscle tester
Vascularization	After six weeks intervention	Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements
Range of motion	After six weeks intervention	Will be measured with goniometer
Modified Tardieu Scale	After six weeks intervention	Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity
Edinburgh visual gait analysis	After six weeks intervention	Gait will be recorded as video and this video will be scored

Secondary Outcome Measures

Name	Time	Method
Child Health Questionnare (Parent form)	After six weeks intervention	Quality of life will be measured by this questionnare
Lower extremity selective control measurement	After six weeks intervention	Selective movement will be measured with this scale. Higher scores mean better selective control.
Children Functional Independence Measurement Scale	After six weeks intervention	Functional Independency will be measured by this scale. Higher scores mean better independence.
Demographic data	After six weeks intervention	Face-to-face interview with family. Will be recorded in data registration form

Trial Locations

Locations (1)

Pelin Atalan; 🇹🇷 İ̇zmi̇r, Bornova, Turkey