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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01590693
Other study ID # S4
Secondary ID
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


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