Cerebral PalsyNCT05312125
Physiotherapy After Botulinum Toxin Injection and Serial Casting
A study testing backward downhill walking and routine physiotherapy in people with Cerebral Palsy and Cerebral Palsy, Spastic, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Cerebral Palsy, Cerebral Palsy, Spastic
- What is being tested?
- backward downhill walking and routine physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2022to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Palsy, Cerebral Palsy, Spastic
- Being tested
- backward downhill walking, routine physiotherapy
- Keywords
- cerebral palsy, botulinum toxin, serial casting, physiotherapy, muscle morphology
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
backward downhill walkingProcedure or surgery
Children in the intervention group will take backward downhill walking program plus to routine physiotherapy.
routine physiotherapyProcedure or surgery
Children in one of the groups will take routine physiotherapy programme
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Children in this group will take routine physiotherapy (stretching, strengthening) program during 6 weeks. 3 days/week. Receives: Procedure: routine physiotherapy |
| intervention group | Active comparator | 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. Receives: Procedure: backward downhill walking; Procedure: routine physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle morphology
Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements
Measured: Before the intervention
Muscle morphology
Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements
Measured: After six weeks intervention
Vascularization
Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements
Measured: Before the the intervention
Vascularization
Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements
Measured: After six weeks intervention
Muscle strenght
Will be measured by manual muscle tester
Measured: Before the intervention
Muscle strenght
Will be measured by manual muscle tester
Measured: After six weeks intervention
Range of motion
Will be measured with goniometer
Measured: Before the intervention.
Range of motion
Will be measured with goniometer
Measured: After six weeks intervention
Edinburgh visual gait analysis
Gait will be recorded as video and this video will be scored
Measured: Before the intervention
Edinburgh visual gait analysis
Gait will be recorded as video and this video will be scored
Measured: After six weeks intervention
Modified Tardieu Scale
Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity
Measured: Before the intervention
Modified Tardieu Scale
Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity
Measured: After six weeks intervention
Secondary outcomes (8)
Demographic data
Face-to-face interview with family. Will be recorded in data registration form
Measured: Before the intervention
Demographic data
Face-to-face interview with family. Will be recorded in data registration form
Measured: After six weeks intervention
Child Health Questionnare (Parent form)
Quality of life will be measured by this questionnare
Measured: Before the intervention
Child Health Questionnare (Parent form)
Quality of life will be measured by this questionnare
Measured: After six weeks intervention
Children Functional Independence Measurement Scale
Functional Independency will be measured by this scale. Higher scores mean better independence.
Measured: Before the intervention
Children Functional Independence Measurement Scale
Functional Independency will be measured by this scale. Higher scores mean better independence.
Measured: After six weeks intervention
Lower extremity selective control measurement
Selective movement will be measured with this scale. Higher scores mean better selective control.
Measured: Before the intervention
Lower extremity selective control measurement
Selective movement will be measured with this scale. Higher scores mean better selective control.
Measured: After six weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start6 Apr 2022
- Primary completion20 Dec 2022
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Gulhane Training and Research Hospital, Ankara Eğitim ve Araştırma Hastanesi
- Responsible party
- Principal investigator, pelin atalan, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312125
- Sponsor's protocol ID
- GaziUniPA
- Status last verified
- Jun 2023
- First submitted
- 8 Mar 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05312125
- Acronym / sponsor ID
- GaziUniPA
- Conditions
- Cerebral Palsy, Cerebral Palsy, Spastic
- Keywords
- cerebral palsy, botulinum toxin, serial casting, physiotherapy, muscle morphology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Gulhane Training and Research Hospital, Ankara Eğitim ve Araştırma Hastanesi
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: routine physiotherapyChildren in this group will take routine physiotherapy (stretching, strengthening) program during 6 weeks. 3 days/week. |
| intervention group | Active comparator | Procedure: backward downhill walking, Procedure: routine physiotherapyChildren in this group will take routine physiotherapy (stretching, strengthening) program + backward downhill walking (10 minutes in a day) during 6 weeks. 3 days/week. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| backward downhill walkingChildren in the intervention group will take backward downhill walking program plus to routine physiotherapy. | Procedure or surgery | intervention group |
| routine physiotherapyChildren in one of the groups will take routine physiotherapy programme | Procedure or surgery | control group, intervention group |
Primary outcome
Muscle morphology
Time frame: Before the intervention
Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements
Muscle morphology
Time frame: After six weeks intervention
Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements
Vascularization
Time frame: Before the the intervention
Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements
Vascularization
Time frame: After six weeks intervention
Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements
Muscle strenght
Time frame: Before the intervention
Will be measured by manual muscle tester
Muscle strenght
Time frame: After six weeks intervention
Will be measured by manual muscle tester
Range of motion
Time frame: Before the intervention.
Will be measured with goniometer
Range of motion
Time frame: After six weeks intervention
Will be measured with goniometer
Edinburgh visual gait analysis
Time frame: Before the intervention
Gait will be recorded as video and this video will be scored
Edinburgh visual gait analysis
Time frame: After six weeks intervention
Gait will be recorded as video and this video will be scored
Modified Tardieu Scale
Time frame: Before the intervention
Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity
Modified Tardieu Scale
Time frame: After six weeks intervention
Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity
8 secondary outcomes
Demographic data
Time frame: Before the intervention
Demographic data
Time frame: After six weeks intervention
Child Health Questionnare (Parent form)
Time frame: Before the intervention
Child Health Questionnare (Parent form)
Time frame: After six weeks intervention
Children Functional Independence Measurement Scale
Time frame: Before the intervention
Children Functional Independence Measurement Scale
Time frame: After six weeks intervention
Lower extremity selective control measurement
Time frame: Before the intervention
Lower extremity selective control measurement
Time frame: After six weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing backward downhill walking and routine physiotherapy in people with Cerebral Palsy and Cerebral Palsy, Spastic, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle morphology (time frame: Before the intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.