Kinesio Taping Effectiveness on Idiopathic Toe Walking

NCT02025582 | Completed Early Phase 1

• 1 other identifier: 13-003848
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Toe Walking

Keywords

idiopathic toe walking; gait disorder; gait analysis; kinesio taping; ultrasound elastography; pediatric; children; muscle stiffness; muscle elasticity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Advanced gait analysis - Change in kinetics

  At enrollment, after completion of taping (2-3 weeks after enrollment)

Other Outcomes (1)

• Supersonic Shearwave Ultrasound Elastography: Change in muscle elasticity

  At enrollment, upon completion of taping (2-3 weeks after enrollment)

Study Arms (1)

Kinesio tape

EXPERIMENTAL

Device: Kinesio Tape of the Ankle

Interventions

Kinesio Tape of the Ankle DEVICE

Tibialis anterior facilitation/ gastrocnemius inhibition: Taping to be worn 3-5 days and repeated x 1

Also known as: Kinesio Tape

Kinesio tape

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Females and males
• years of age
• who independently ambulate
• have a diagnosis of idiopathic toe walking

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Officials

• Hadiya Guerrero, DPT

  Mayo Clinic Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hadiya Guerrero, P.T., D.P.T.

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: January 1, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

US (1)