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Botulinum Toxin A for Idiopathic Toe-walking

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590693
First Posted: May 3, 2012
Last Update Posted: May 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pahr Engstrom, Karolinska Institutet
  Purpose
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.

Condition Intervention
Idiopathic Toe-walking Drug: Botulinum toxin A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Botulinum Toxin A Does Not Improve Cast Treatment for Idiopathic Toe-walking- a Prospective Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Pahr Engstrom, Karolinska Institutet:

Primary Outcome Measures:
  • Percentage of toe-walking [ Time Frame: baseline, 3month, 12 month ]

Secondary Outcome Measures:
  • Joint range of movement [ Time Frame: Baseline, 3 month, 12 month ]
  • Classification of idiopathic toe-walking [ Time Frame: Baseline, 3 month, 12 month ]
  • Gait analysis parameters [ Time Frame: Baseline, 3 month, 12 month ]

Enrollment: 52
Study Start Date: November 2005
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 2
Children treated with four weeks of below knee walking casts and botulinum toxin A injections
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.
Active Comparator: Group 1
Children treated with four weeks of below knee walking casts.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590693


Locations
Sweden
Astrid Lindren Children's Hospital
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Pähr Engstrom, MD., Dr. Karolinska Institutet
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pahr Engstrom, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01590693     History of Changes
Other Study ID Numbers: S4
First Submitted: May 1, 2012
First Posted: May 3, 2012
Last Update Posted: May 3, 2012
Last Verified: May 2012

Keywords provided by Pahr Engstrom, Karolinska Institutet:
Gait

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents