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Physiotherapy After Botulinum Toxin Injection and Serial Casting

Primary Purpose

Cerebral Palsy, Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
backward downhill walking
routine physiotherapy
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, botulinum toxin, serial casting, physiotherapy, muscle morphology

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pelin Atalan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

control group

intervention group

Arm Description

Children in this group will take routine physiotherapy (stretching, strengthening) program during 6 weeks. 3 days/week.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2022
Last Updated
June 14, 2023
Sponsor
Gazi University
Collaborators
Gulhane Training and Research Hospital, Ankara Eğitim ve Araştırma Hastanesi
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1. Study Identification

Unique Protocol Identification Number
NCT05312125
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
Collaborators
Gulhane Training and Research Hospital, Ankara Eğitim ve Araştırma Hastanesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Cerebral Palsy, Spastic
Keywords
cerebral palsy, botulinum toxin, serial casting, physiotherapy, muscle morphology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Children in this group will take routine physiotherapy (stretching, strengthening) program during 6 weeks. 3 days/week.
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
backward downhill walking
Intervention Description
Children in the intervention group will take backward downhill walking program plus to routine physiotherapy.
Intervention Type
Procedure
Intervention Name(s)
routine physiotherapy
Intervention Description
Children in one of the groups will take routine physiotherapy programme
Primary Outcome Measure Information:
Title
Muscle morphology
Description
Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements
Time Frame
Before the intervention
Title
Muscle morphology
Description
Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements
Time Frame
After six weeks intervention
Title
Vascularization
Description
Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements
Time Frame
Before the the intervention
Title
Vascularization
Description
Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements
Time Frame
After six weeks intervention
Title
Muscle strenght
Description
Will be measured by manual muscle tester
Time Frame
Before the intervention
Title
Muscle strenght
Description
Will be measured by manual muscle tester
Time Frame
After six weeks intervention
Title
Range of motion
Description
Will be measured with goniometer
Time Frame
Before the intervention.
Title
Range of motion
Description
Will be measured with goniometer
Time Frame
After six weeks intervention
Title
Edinburgh visual gait analysis
Description
Gait will be recorded as video and this video will be scored
Time Frame
Before the intervention
Title
Edinburgh visual gait analysis
Description
Gait will be recorded as video and this video will be scored
Time Frame
After six weeks intervention
Title
Modified Tardieu Scale
Description
Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity
Time Frame
Before the intervention
Title
Modified Tardieu Scale
Description
Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity
Time Frame
After six weeks intervention
Secondary Outcome Measure Information:
Title
Demographic data
Description
Face-to-face interview with family. Will be recorded in data registration form
Time Frame
Before the intervention
Title
Demographic data
Description
Face-to-face interview with family. Will be recorded in data registration form
Time Frame
After six weeks intervention
Title
Child Health Questionnare (Parent form)
Description
Quality of life will be measured by this questionnare
Time Frame
Before the intervention
Title
Child Health Questionnare (Parent form)
Description
Quality of life will be measured by this questionnare
Time Frame
After six weeks intervention
Title
Children Functional Independence Measurement Scale
Description
Functional Independency will be measured by this scale. Higher scores mean better independence.
Time Frame
Before the intervention
Title
Children Functional Independence Measurement Scale
Description
Functional Independency will be measured by this scale. Higher scores mean better independence.
Time Frame
After six weeks intervention
Title
Lower extremity selective control measurement
Description
Selective movement will be measured with this scale. Higher scores mean better selective control.
Time Frame
Before the intervention
Title
Lower extremity selective control measurement
Description
Selective movement will be measured with this scale. Higher scores mean better selective control.
Time Frame
After six weeks intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pelin Atalan
City
İ̇zmi̇r
State/Province
Bornova
ZIP/Postal Code
35050
Country
Turkey

12. IPD Sharing Statement

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Physiotherapy After Botulinum Toxin Injection and Serial Casting

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