Physiotherapy After Botulinum Toxin Injection and Serial Casting

NCT05312125 | Completed

• 1 other identifier: GaziUniPA
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Cerebral Palsy, Spastic

Keywords

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

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (8)

• Demographic data

  Before the intervention

• Demographic data

  After six weeks intervention

• Child Health Questionnare (Parent form)

  Before the intervention

• Child Health Questionnare (Parent form)

  After six weeks intervention

• Children Functional Independence Measurement Scale

  Before the intervention

Study Arms (2)

control group

ACTIVE COMPARATOR

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

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.

Procedure: backward downhill walking; Procedure: routine physiotherapy

Interventions

backward downhill walking PROCEDURE

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

intervention group

routine physiotherapy PROCEDURE

Children in one of the groups will take routine physiotherapy programme

control group; intervention group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead
• Gulhane Training and Research Hospital: collaborator
• Ankara Eğitim ve Araştırma Hastanesi: collaborator

Study Sites (1)

Pelin Atalan

Izmir, Bornova, 35050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 5, 2022
• Study Start: April 6, 2022
• Primary Completion: December 20, 2022
• Study Completion: April 20, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

TU (1)