- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03403322
Kinesio Taping in Sit to Stand Movement fo Cerebral Palsy
January 11, 2018 updated by: Adriana Neves Dos Santos, Universidade Federal de Santa Catarina
Imediate Effects of Kinesio Tapin in Muscle Activity and Time to Perform Sit to Stand Movement in Children With Cerebral Palsy
Children with Cerebral Palsy (CP) present limited performance of functional activities and activities of daily life.
Kinesio taping has been definied as a promising technique for children with CP ans has been extensively used in clinical practice.
However, several studies have found a low level of evidence of its effectiveness in healthy individuals.
We aim to evaluate the effects of the immediate application of Kinesio taping on the activation of the rectus femoris and anterior tibialis muscles and on the duration of sit-to-stand movement in children with CP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
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
-
-
Santa Catarina
-
Araranguá, Santa Catarina, Brazil, 88.906-072
- Universidade Federal de Santa Catarina
-
-
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
5 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosed with spastic CP
- aged from 5 to 18 years
- Gross Motor Function Classification System levels I and II
- able to understand simple commands
- able to perform the sit-to-stand movement without support
Exclusion Criteria:
- muscle shortening in hamstring, gastrocnemius and hip flexors
- deformities in the lower limbs such as fixed hip and knee flexion that could compromise the sit-to-stand movement
- surgical procedures in the lower limbs and trunk in the previous 12 months
- botulinum toxin injection in the previous 6 months
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: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: First test
All measures were evaluated
|
An experienced physiotherapist placed the base of the Kinesio taping strip, over rectus femoris muscle, 3cm bellow the anterior iliac spine, without tension.
From this point, the Kinesio taping was placed up to the upper edge of the patella and stretched to 100% tension.
It was, then, bi-sectioned, circled the patella and ended in the tuberosity of the femur, without tension.
In order to avoid interference in the electromyography signals, a section was held at Kinesio taping at the point where the electrode was placed.
Children performed functional activities without tape
|
|
OTHER: Second test
All measures were evaluated
|
An experienced physiotherapist placed the base of the Kinesio taping strip, over rectus femoris muscle, 3cm bellow the anterior iliac spine, without tension.
From this point, the Kinesio taping was placed up to the upper edge of the patella and stretched to 100% tension.
It was, then, bi-sectioned, circled the patella and ended in the tuberosity of the femur, without tension.
In order to avoid interference in the electromyography signals, a section was held at Kinesio taping at the point where the electrode was placed.
Children performed functional activities without tape
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle activity
Time Frame: on the day of evaluation
|
An electromyography analysis was performed to evaluate the rectus femoris and tibialis anterior activity during the sit-to-stand movement and the five time sit-to-stand test.
Electrodes were placed in both lower limbs.
Mean root mean square (mRMS) values were used for statistical analysis.
Mean root mean square values were normalized by the maximum value of each trial and individual.
|
on the day of evaluation
|
|
Time to perform sit to stand
Time Frame: on the day of evaluation
|
Children were seated with hip, knee and ankle flexed at 90°.
Both feet were symmetrically positioned shoulder width apart and arms were crossed over the chest.
Children should get up from the seat after the verbal command of the evaluator.
Children performed the sit-to-stand movement at a speed that simulated the one usually adopted in daily routine
|
on the day of evaluation
|
|
Time to perform five time sit-to-stand test
Time Frame: on the day of evaluation
|
Children had to get up and sit down five times as fast as possible.
The instructions before starting the test were: "Stand up and sit down as quickly as possible for 5 times.
The test will be finished when you return to the seated position the 5th time.
Continue the sit-to-stand movement until I ask you to stop.
If you try but cannot stand up, just let me know.
Ready?
go!"
|
on the day of evaluation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (ACTUAL)
April 1, 2016
Primary Completion (ACTUAL)
August 30, 2017
Study Completion (ACTUAL)
December 30, 2017
Study Registration Dates
First Submitted
January 11, 2018
First Submitted That Met QC Criteria
January 11, 2018
First Posted (ACTUAL)
January 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 18, 2018
Last Update Submitted That Met QC Criteria
January 11, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFSC-SIGPEX / 201702940
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be available
IPD Sharing Time Frame
Data will be available within one year of study completion
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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