Kinesio Taping Effectiveness on Idiopathic Toe Walking

Idiopathic Toe Walking Clinical Trial

Official title:

The Effectiveness and Efficacy of Kinesio Taping Method on Muscle Elasticity in Children Who Toe Walk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02025582
• Other study ID #: 13-003848
• Status: Recruiting
• Phase: N/A
• First received: December 27, 2013
• Last updated: September 3, 2015
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Idiopathic Toe Walking (ITW) is a diagnosis normally of exclusion and likely, consequently, is approached in vastly varying ways of intervention, including serial casting, Botox injections and physical therapy. There is some evidence in the literature that children with ITW can somewhat correct their lack of heel-strike gait pattern at least temporarily. Kinesio Taping (KT) method is an intervention that is used in the outpatient physical therapy setting for various conditions such as post-operative edema, muscle facilitation of weakened rotator cuff muscles, and functional corrections in children with torticollis. This pilot study will strive to determine if KT may be effective by providing proprioceptive and neuromuscular re-education through thermal and mechanical fascial impositions, thereby improving passive joint range of motion (ROM) through reduction of passive muscle stiffness and improving ambulation through neuromuscular re-education in children with idiopathic toe walking. We will quantify passive muscle stiffness of the gastrocnemius and opposing anterior tibialis using non-invasive Shear Wave Elastography (SWE). Further we look at the kinematics and kinetics of the child's ankle during the gait cycle to further determine any effect(s) of KT on functional walking outcome measures. The intent is that the results from this study will serve as a platform from which to expound look at the long-term, if any, effects of KT on the muscle property and gait cycle pattern in children with ITW.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

• Females and males

• 3-10 years of age

• who independently ambulate

• have a diagnosis of idiopathic toe walking

Exclusion Criteria:

• Children will be excluded if they have a diagnosis of or suspected neuromuscular disorder

• had prior treatment for ITW including bracing or including splinting in the last six months, chemodenervation, serial casting in the last six months, surgical intervention

• diagnosis of Autism or Pervasive Developmental Disorder

• history of allergic reactions to tape/adhesives.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Toe Walking

Intervention

Device:
• Kinesio Tape of the Ankle
Tibialis anterior facilitation/ gastrocnemius inhibition: Taping to be worn 3-5 days and repeated x 1

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Supersonic Shearwave Ultrasound Elastography: Change in muscle elasticity	Currently, there is indirect evidence that children with ITW have increased passive stiffness of the gastrocnemius muscle, and no evidence with regard to passive stiffness of the anterior tibialis, a major ankle plantar flexion antagonist. Abnormal passive stiffness of these muscles is thought to result in the loss of passive ROM and changes to ambulation. However, direct measurements of passive muscles stiffness in children have not been able to be done, until recently. Therefore, we propose to quantify the passive muscle stiffness of the gastrocnemius muscle and anterior tibialis muscle in children with ITW before and after KT treatment using SWE.	At enrollment, upon completion of taping (2-3 weeks after enrollment)	No
Primary	Change in Ankle Joint Range of Motion	To evaluate effect of KT on passive ankle ROM, we will measure passive ankle ROM before and after treatment. With the child laying prone, measurements of ankle ROM will be taken using a goniometer with the knee extended and with the knee flexed at 90 degrees. The rationale for this is to differentiate gastrocnemius muscle from soleus muscle, with gastrocnemius contributing to ankle ROM loss when knee is extended because it crosses both joints.	At enrollment, one and two week after kinesio taping	No
Secondary	Advanced gait analysis - Change in kinetics	In children with ITW, gait changes, as measured by ankle kinetics and kinematics, have been shown as toe-walking improves. In ITW, presence of a first ankle rocker, presence of an early third ankle rocker, and predominant early ankle moment on advanced gait analysis are used to classify idiopathic toe walking into three severity groups. Changes to these parameters are used to evaluate effect of treatment on ITW. Therefore, we propose to use these parameters to classify the severity of the ITW before and after KT treatment to evaluate effect of KT on ambulation.	At enrollment, after completion of taping (2-3 weeks after enrollment)	No