Botulinum Toxin A for Idiopathic Toe-walking

Idiopathic Toe-walking Clinical Trial

Official title:

Botulinum Toxin A Does Not Improve Cast Treatment for Idiopathic Toe-walking- a Prospective Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590693
• Other study ID #: S4
• Status: Completed
• Phase: N/A
• First received: May 1, 2012
• Last updated: May 2, 2012
• Start date: November 2005
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Toe-walking

Intervention

Drug:
• Botulinum toxin A
The children in Group 2 underwent bilateral treatment with a total of 12 units/kg bodyweight Botox® (Allergan, California, USA). Four injection sites in each calf - two in the proximal third of the lateral and medial gastrocnemius bellies and two distally in the gastrocnemius-soleus complex - were administered. All injections were performed with electromyogram amplifier guidance to ensure intramuscular position. Children in both groups were treated with four weeks of below knee walking casts. Children in group 2 received the casts 1-2 weeks after botulinum toxin A treatment.

Locations

Country	Name	City	State
Sweden	Astrid Lindren Children's Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of toe-walking		baseline, 3month, 12 month	Yes
Secondary	Joint range of movement		Baseline, 3 month, 12 month	Yes
Secondary	Classification of idiopathic toe-walking		Baseline, 3 month, 12 month	Yes
Secondary	Gait analysis parameters		Baseline, 3 month, 12 month	Yes