Botulinum Toxin A for Idiopathic Toe-walking

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01590693

Enrollment

Registered

2012-05-03

Start date

2005-11-30

Completion date

2012-04-30

Last updated

2012-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Toe-walking

Keywords

Gait

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.

Interventions

DRUGBotulinum 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 15 Years

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

Design outcomes

Primary

Measure	Time frame
Percentage of toe-walking	baseline, 3month, 12 month

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026