Botulinum Toxin A for Idiopathic Toe-walking

Karolinska Institute

Status: Completed

Conditions: Idiopathic Toe-walking

Treatments: Drug: Botulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT01590693

S4

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Group 2

Experimental group

Description:

Children treated with four weeks of below knee walking casts and botulinum toxin A injections

Treatment:

Drug: Botulinum toxin A

Group 1

Active Comparator group

Description:

Children treated with four weeks of below knee walking casts.

Treatment:

Drug: Botulinum toxin A