NCT03403322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

January 11, 2018

Last Update Submit

January 11, 2018

Conditions

Keywords

interventionchildren

Outcome Measures

Primary Outcomes (3)

  • 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.

    on the day of evaluation

  • 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

    on the day of evaluation

  • 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!"

    on the day of evaluation

Study Arms (2)

First test

OTHER

All measures were evaluated

Other: Kinesio tapingOther: Without taping

Second test

OTHER

All measures were evaluated

Other: Kinesio tapingOther: Without taping

Interventions

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.

First testSecond test

Children performed functional activities without tape

First testSecond test

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Santa Catarina

Araranguá, Santa Catarina, 88.906-072, Brazil

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person that performed data analysis was blind to all conditions.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Reseacher

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

April 1, 2016

Primary Completion

August 30, 2017

Study Completion

December 30, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be available

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available within one year of study completion

Locations