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Completed

NCT Number: NCT01590693

Botulinum Toxin A for Idiopathic Toe-walking

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.

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Key information

Conditions

Idiopathic Toe-walking

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Astrid Lindren Children's Hospital

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin A

Drug

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.

Primary outcomes

  1. Percentage of toe-walking

    Time frame: baseline, 3month, 12 month

Secondary outcomes

  1. Joint range of movement

    Time frame: Baseline, 3 month, 12 month

  2. Classification of idiopathic toe-walking

    Time frame: Baseline, 3 month, 12 month

  3. Gait analysis parameters

    Time frame: Baseline, 3 month, 12 month

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
May 3, 2012
Registry last updated
May 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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