Botulinum Toxin A for Idiopathic Toe-walking
- Registration Number
- NCT01590693
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
The purpose of this study is to determine whether botulinum toxin A (BTX) adds a favourable effect to treatment of idiopathic toe-walking with below knee walking casts. The specific hypothesis to be tested is that a combination of BTX and casting is more effective than casting treatment alone in reducing toe-walking in 5-15 year old children. Evaluation methods include 3-D gait analysis, parents' perception of toe-walking frequency, passive joint range of motion measurements, and strength of ankle dorsal extension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- Children with idiopathic toe-walking
- 5-15 years of age
Exclusion Criteria
- Previous treatment for idiopathic toe-walking, such as, Achilles tendon surgery, casting, orthotics, and BTX treatment.
- Flexion contracture beyond -10 degrees in the ankle
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Botulinum toxin A Children treated with four weeks of below knee walking casts. Group 2 Botulinum toxin A Children treated with four weeks of below knee walking casts and botulinum toxin A injections
- Primary Outcome Measures
Name Time Method Percentage of toe-walking baseline, 3month, 12 month
- Secondary Outcome Measures
Name Time Method Joint range of movement Baseline, 3 month, 12 month Classification of idiopathic toe-walking Baseline, 3 month, 12 month Gait analysis parameters Baseline, 3 month, 12 month
Trial Locations
- Locations (1)
Astrid Lindren Children's Hospital
🇸🇪Stockholm, Sweden