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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05312125
Enrollment
19
Registered
2022-04-05
Start date
2022-04-06
Completion date
2023-04-20
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Cerebral Palsy, Spastic

Keywords

cerebral palsy, botulinum toxin, serial casting, physiotherapy, muscle morphology

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.

Interventions

PROCEDUREbackward downhill walking

Children in the intervention group will take backward downhill walking program plus to routine physiotherapy.

Children in one of the groups will take routine physiotherapy programme

Sponsors

Gulhane Training and Research Hospital
CollaboratorOTHER_GOV
Ankara Eğitim ve Araştırma Hastanesi
CollaboratorUNKNOWN
Gazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Tardieu ScaleBefore the interventionLower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity
VascularizationBefore the the interventionMuscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements
Muscle strenghtBefore the interventionWill be measured by manual muscle tester
Range of motionBefore the intervention.Will be measured with goniometer
Edinburgh visual gait analysisBefore the interventionGait will be recorded as video and this video will be scored
Muscle morphologyBefore the interventionMuscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements

Secondary

MeasureTime frameDescription
Child Health Questionnare (Parent form)Before the interventionQuality of life will be measured by this questionnare
Children Functional Independence Measurement ScaleBefore the interventionFunctional Independency will be measured by this scale. Higher scores mean better independence.
Lower extremity selective control measurementBefore the interventionSelective movement will be measured with this scale. Higher scores mean better selective control.
Demographic dataBefore the interventionFace-to-face interview with family. Will be recorded in data registration form

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026