Idiopathic Toe WalkingEarly Phase 1NCT02025582
Kinesio Taping Effectiveness on Idiopathic Toe Walking
A Early Phase 1 study testing Kinesio Tape of the Ankle in people with Idiopathic Toe Walking, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Idiopathic Toe Walking
- What is being tested?
- Kinesio Tape of the Ankle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Mar 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Females and males
- 3-10 years of age
- who independently ambulate
- have a diagnosis of idiopathic toe walking
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Idiopathic Toe Walking
- Being tested
- Kinesio Tape of the Ankle
- Keywords
- idiopathic toe walking, gait disorder, gait analysis, kinesio taping, ultrasound elastography, pediatric, children, muscle stiffness, muscle elasticity
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio Tape of the AnkleDevice
Also called Kinesio Tape
Tibialis anterior facilitation/ gastrocnemius inhibition: Taping to be worn 3-5 days and repeated x 1
| Study group | Role | What they receive |
|---|---|---|
| Kinesio tape | Experimental | Not described Receives: Device: Kinesio Tape of the Ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment, one and two week after kinesio taping
Secondary outcomes (1)
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.
Measured: At enrollment, after completion of taping (2-3 weeks after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Toe WalkingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadiya Guerrero, P.T., Mayo Clinic
- Investigators
- Hadiya Guerrero, DPT, Principal investigator, Mayo Clinic Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025582
- Sponsor's protocol ID
- 13-003848
- Status last verified
- Apr 2016
- First submitted
- 27 Dec 2013
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Efficacy of Kinesio Taping Method on Muscle Elasticity in Children Who Toe Walk
- ClinicalTrials.gov ID
- NCT02025582
- Acronym / sponsor ID
- 13-003848
- Conditions
- Idiopathic Toe Walking
- Keywords
- idiopathic toe walking, gait disorder, gait analysis, kinesio taping, ultrasound elastography, pediatric, children, muscle stiffness
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kinesio tape | Experimental | Device: Kinesio Tape of the Ankle |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Females and males
- 3-10 years of age
- who independently ambulate
- have a diagnosis of idiopathic toe walking
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio Tape of the AnkleAlso: Kinesio TapeTibialis anterior facilitation/ gastrocnemius inhibition: Taping to be worn 3-5 days and repeated x 1 | Device | Kinesio tape |
Primary outcome
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.
1 secondary outcome
Advanced gait analysis - Change in kinetics
Time frame: At enrollment, after completion of taping (2-3 weeks after enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadiya Guerrero, DPT principal investigator
Mayo Clinic Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Kinesio Tape of the Ankle in people with Idiopathic Toe Walking, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ankle Joint Range of Motion (time frame: At enrollment, one and two week after kinesio taping). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016.