Botulinum Toxin A for Idiopathic Toe-walking

NCT01590693 | Completed

• 1 other identifier: S4
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Toe-walking

Keywords

Gait

Outcome Measures

Primary Outcomes (1)

• Percentage of toe-walking

  baseline, 3month, 12 month

Secondary Outcomes (3)

• 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

Study Arms (2)

Group 2

EXPERIMENTAL

Children treated with four weeks of below knee walking casts and botulinum toxin A injections

Drug: Botulinum toxin A

Group 1

ACTIVE COMPARATOR

Children treated with four weeks of below knee walking casts.

Drug: Botulinum toxin A

Interventions

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.

Group 1; Group 2

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with idiopathic toe-walking
• years of age

You may not qualify if:

• Previous treatment for idiopathic toe-walking, such as, Achilles tendon surgery, casting, orthotics, and BTX treatment.
• Flexion contracture beyond -10 degrees in the ankle

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Astrid Lindren Children's Hospital

Stockholm, Sweden

Location

Related Publications (1)

• Engstrom P, Bartonek A, Tedroff K, Orefelt C, Haglund-Akerlind Y, Gutierrez-Farewik EM. Botulinum toxin A does not improve the results of cast treatment for idiopathic toe-walking: a randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):400-7. doi: 10.2106/JBJS.L.00889.

  PMID: 23467862 DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Pähr Engstrom, MD., Dr.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 3, 2012
• Study Start: November 1, 2005
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

SE (1)