- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02025582
Kinesio Taping Effectiveness on Idiopathic Toe Walking
April 21, 2016 updated by: Hadiya Guerrero, P.T., Mayo Clinic
The Effectiveness and Efficacy of Kinesio Taping Method on Muscle Elasticity in Children Who Toe Walk
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Early Phase 1
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
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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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
3 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kinesio tape
|
Tibialis anterior facilitation/ gastrocnemius inhibition: Taping to be worn 3-5 days and repeated x 1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Ankle Joint Range of Motion
Time Frame: At enrollment, one and two week after kinesio taping
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Advanced gait analysis - Change in kinetics
Time Frame: At enrollment, after completion of taping (2-3 weeks after enrollment)
|
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.
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At enrollment, after completion of taping (2-3 weeks after enrollment)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Supersonic Shearwave Ultrasound Elastography: Change in muscle elasticity
Time Frame: At enrollment, upon completion of taping (2-3 weeks after enrollment)
|
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.
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At enrollment, upon completion of taping (2-3 weeks after enrollment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hadiya Guerrero, DPT, Mayo Clinic Foundation
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
December 1, 2013
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
December 27, 2013
First Submitted That Met QC Criteria
December 30, 2013
First Posted (Estimate)
January 1, 2014
Study Record Updates
Last Update Posted (Estimate)
April 22, 2016
Last Update Submitted That Met QC Criteria
April 21, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13-003848
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.
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