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NCT Number: NCT05312125

Physiotherapy After Botulinum Toxin Injection and Serial Casting

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy, Spastic Nervous System Diseases

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pelin Atalan

Izmir, Bornova, 35050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

backward downhill walking

Procedure

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

routine physiotherapy

Procedure

Children in one of the groups will take routine physiotherapy programme

Primary outcomes

  1. Muscle morphology

    Time frame: Before the intervention

    Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements

  2. Muscle morphology

    Time frame: After six weeks intervention

    Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements

  3. Vascularization

    Time frame: Before the the intervention

    Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements

  4. Vascularization

    Time frame: After six weeks intervention

    Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements

  5. Muscle strenght

    Time frame: Before the intervention

    Will be measured by manual muscle tester

  6. Muscle strenght

    Time frame: After six weeks intervention

    Will be measured by manual muscle tester

  7. Range of motion

    Time frame: Before the intervention.

    Will be measured with goniometer

  8. Range of motion

    Time frame: After six weeks intervention

    Will be measured with goniometer

  9. Edinburgh visual gait analysis

    Time frame: Before the intervention

    Gait will be recorded as video and this video will be scored

  10. Edinburgh visual gait analysis

    Time frame: After six weeks intervention

    Gait will be recorded as video and this video will be scored

  11. Modified Tardieu Scale

    Time frame: Before the intervention

    Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity

  12. Modified Tardieu Scale

    Time frame: After six weeks intervention

    Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity

Secondary outcomes

  1. Demographic data

    Time frame: Before the intervention

    Face-to-face interview with family. Will be recorded in data registration form

  2. Demographic data

    Time frame: After six weeks intervention

    Face-to-face interview with family. Will be recorded in data registration form

  3. Child Health Questionnare (Parent form)

    Time frame: Before the intervention

    Quality of life will be measured by this questionnare

  4. Child Health Questionnare (Parent form)

    Time frame: After six weeks intervention

    Quality of life will be measured by this questionnare

  5. Children Functional Independence Measurement Scale

    Time frame: Before the intervention

    Functional Independency will be measured by this scale. Higher scores mean better independence.

  6. Children Functional Independence Measurement Scale

    Time frame: After six weeks intervention

    Functional Independency will be measured by this scale. Higher scores mean better independence.

  7. Lower extremity selective control measurement

    Time frame: Before the intervention

    Selective movement will be measured with this scale. Higher scores mean better selective control.

  8. Lower extremity selective control measurement

    Time frame: After six weeks intervention

    Selective movement will be measured with this scale. Higher scores mean better selective control.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Collaborators

  • Ankara Eğitim ve Araştırma Hastanesi
  • Gulhane Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 5, 2022
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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