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Botulinum Toxin A for Idiopathic Toe-walking

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pahr Engstrom, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01590693
First received: May 1, 2012
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Percentage of toe-walking [ Time Frame: baseline, 3month, 12 month ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Karolinska Institutet

Additional 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
Study First Received: May 1, 2012
Last Updated: May 2, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
Gait

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013