Botulinum Toxin A for Idiopathic Toe-walking

May 2, 2012 updated by: Pahr Engstrom, Karolinska Institutet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Astrid Lindren Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of toe-walking
Time Frame: baseline, 3month, 12 month
baseline, 3month, 12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Joint range of movement
Time Frame: Baseline, 3 month, 12 month
Baseline, 3 month, 12 month
Classification of idiopathic toe-walking
Time Frame: Baseline, 3 month, 12 month
Baseline, 3 month, 12 month
Gait analysis parameters
Time Frame: Baseline, 3 month, 12 month
Baseline, 3 month, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Pähr Engstrom, MD., Dr., Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

May 1, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Toe-walking

Clinical Trials on Botulinum toxin A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe