Physiotherapy After Botulinum Toxin Injection and Serial Casting

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05312125
• Other study ID #: GaziUniPA
• Status: Completed
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: June 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 20, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Paralysis

Intervention

Procedure:
• backward downhill walking
Children in the intervention group will take backward downhill walking program plus to routine physiotherapy.
• routine physiotherapy
Children in one of the groups will take routine physiotherapy programme

Locations

Country	Name	City	State
Turkey	Pelin Atalan	I?zmi?r	Bornova

Sponsors (3)

Lead Sponsor	Collaborator
Gazi University	Ankara Egitim ve Arastirma Hastanesi, Gulhane Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle morphology	Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements	Before the intervention
Primary	Muscle morphology	Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements	After six weeks intervention
Primary	Vascularization	Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements	Before the the intervention
Primary	Vascularization	Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements	After six weeks intervention
Primary	Muscle strenght	Will be measured by manual muscle tester	Before the intervention
Primary	Muscle strenght	Will be measured by manual muscle tester	After six weeks intervention
Primary	Range of motion	Will be measured with goniometer	Before the intervention.
Primary	Range of motion	Will be measured with goniometer	After six weeks intervention
Primary	Edinburgh visual gait analysis	Gait will be recorded as video and this video will be scored	Before the intervention
Primary	Edinburgh visual gait analysis	Gait will be recorded as video and this video will be scored	After six weeks intervention
Primary	Modified Tardieu Scale	Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity	Before the intervention
Primary	Modified Tardieu Scale	Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity	After six weeks intervention
Secondary	Demographic data	Face-to-face interview with family. Will be recorded in data registration form	Before the intervention
Secondary	Demographic data	Face-to-face interview with family. Will be recorded in data registration form	After six weeks intervention
Secondary	Child Health Questionnare (Parent form)	Quality of life will be measured by this questionnare	Before the intervention
Secondary	Child Health Questionnare (Parent form)	Quality of life will be measured by this questionnare	After six weeks intervention
Secondary	Children Functional Independence Measurement Scale	Functional Independency will be measured by this scale. Higher scores mean better independence.	Before the intervention
Secondary	Children Functional Independence Measurement Scale	Functional Independency will be measured by this scale. Higher scores mean better independence.	After six weeks intervention
Secondary	Lower extremity selective control measurement	Selective movement will be measured with this scale. Higher scores mean better selective control.	Before the intervention
Secondary	Lower extremity selective control measurement	Selective movement will be measured with this scale. Higher scores mean better selective control.	After six weeks intervention