Physiotherapy After Botulinum Toxin Injection and Serial Casting

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Cerebral Palsy, Spastic
• Intervention / Treatment: Procedure: routine physiotherapy; Procedure: backward downhill walking

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İ̇zmi̇r, Bornova, Turkey, 35050
      • Pelin Atalan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; Children in this group will take routine physiotherapy (stretching, strengthening) program during 6 weeks. 3 days/week.	Procedure: routine physiotherapy; Children in one of the groups will take routine physiotherapy programme
Active Comparator: 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.	Procedure: routine physiotherapy; Children in one of the groups will take routine physiotherapy programme; Procedure: backward downhill walking; Children in the intervention group will take backward downhill walking program plus to routine physiotherapy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gazi University
• Collaborators: Gulhane Training and Research Hospital; Ankara Eğitim ve Araştırma Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: physiotherapy; cerebral palsy; botulinum toxin; muscle morphology; serial casting
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: GaziUniPA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No