Back to resultsKinesio Taping in Sit to Stand Movement fo Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Kinesio taping
Without taping
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring intervention, children
Eligibility Criteria
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
Sites / Locations
- Universidade Federal de Santa Catarina
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
First test
Second test
Arm Description
All measures were evaluated
All measures were evaluated
Outcomes
Primary Outcome Measures
Muscle activity
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.
Time to perform sit to stand
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
Time to perform five time sit-to-stand test
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!"
Secondary Outcome Measures
Full Information
NCT ID
NCT03403322
First Posted
January 11, 2018
Last Updated
January 11, 2018
Sponsor
Universidade Federal de Santa Catarina
1. Study Identification
Unique Protocol Identification Number
NCT03403322
Brief Title
Kinesio Taping in Sit to Stand Movement fo Cerebral Palsy
Official Title
Imediate Effects of Kinesio Tapin in Muscle Activity and Time to Perform Sit to Stand Movement in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Catarina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
intervention, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Masking Description
The person that performed data analysis was blind to all conditions.
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First test
Arm Type
Other
Arm Description
All measures were evaluated
Arm Title
Second test
Arm Type
Other
Arm Description
All measures were evaluated
Intervention Type
Other
Intervention Name(s)
Kinesio taping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Without taping
Intervention Description
Children performed functional activities without tape
Primary Outcome Measure Information:
Title
Muscle activity
Description
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.
Time Frame
on the day of evaluation
Title
Time to perform sit to stand
Description
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
Time Frame
on the day of evaluation
Title
Time to perform five time sit-to-stand test
Description
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!"
Time Frame
on the day of evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universidade Federal de Santa Catarina
City
Araranguá
State/Province
Santa Catarina
ZIP/Postal Code
88.906-072
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Kinesio Taping in Sit to Stand Movement fo Cerebral Palsy
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