Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000635268
Ethics application status
Approved
Date submitted
7/03/2018
Date registered
23/04/2018
Date last updated
27/03/2019
Date data sharing statement initially provided
27/03/2019
Date results information initially provided
27/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Kinesio Taping (KT) on shoulder biomechanics during a virtual reality-based reaching task in children with cerebral palsy: A randomized controlled clinical trial
Scientific title
The effect of Kinesio Taping (KT) on shoulder biomechanics during a virtual reality-based reaching task in children with cerebral palsy: A randomized controlled clinical trial
Secondary ID [1] 294267 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 306950 0
Condition category
Condition code
Neurological 306048 306048 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 306473 306473 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will perform the following activities:
A) upper limb exercises using a virtual reality tracking and measuring system. The exercises will consist in reaching and transporting three virtual objects with the upper limb movement visualization through a virtual body or through a sphere representing the hand position. They will be perform in a seating position.
B) Shoulder flexion/extension, abduction/adduction and external/internal rotation movements. This activity is to measure shoulder active Range Of Motion (aROM) by using the virtual reality tracking and measuring system.

Activity A and B will be achieved twice, first, without Kinesio tape applied to the shoulder and after, with Kinesio tape.
A trained physiotherapist will apply elastic tapes in the shoulder according to well established method.
The same physiotherapist will measure the following aspects:
a) Box and Block Test (BBT) score (before and after the intervention)
b) Passive Range Of Motion (pROM) of the affected shoulder with a conventional goniometer (before the intervention)

The following measurements will be taken by using a tracking camera (Kinect v2) and real time algorithms integrated into the virtual reality tracking and measuring system: (i) time to execute activity A, (ii) angular and cartesian variables, such as position, velocity and acceleration, (iii) dynamic variables, such as torques and (iv) derived metrics, such as mechanical energy spend and movement smoothness.

All measurements and activities will be performed in the same day and in the following chronologically order:
(1) BBT
(2) pROM measurements for shoulder
(3) aROM measurements for shoulder
(4) Reaching and transporting exercises with and without body movement visualization, or vice-versa
(5) Application of Kinesio tape
(6) BBT
(7) aROM measurements for shoulder
(8) Reaching and transporting exercises with and without body movement visualization, or vice-versa

Steps from 1 to 4 will be performed without Kinesio tape and from 6 to 8 with Kinesio tape. A short practice period before starting step 4 will be considered and short breaks between the different activities will be allowed. The total duration of the intervention will be approximately of 1 hour and 10 min. Besides the visual and auditory biofeedback from the virtual reality tracking and measuring system, participants will receive encouragement from therapists and general verbal performance feedback in order to engage them as much as possible and to increase their active participation and motivation.
Intervention code [1] 300557 0
Treatment: Other
Intervention code [2] 300558 0
Rehabilitation
Comparator / control treatment
The control group will perform the same activities (A and B) and same number of times (2) than Treatment group, but without Kinesio tape applied to the shoulder.

A trained physiotherapist (same than in Treatment group) will measure the following aspects:
a) Box and Block Test (BBT) score (before and after activity A and B)
b) Passive Range Of Motion (pROM) of the affected shoulder with a conventional goniometer (before activity A and B)

The same measurements taken with the Treatment group will be measured with the Control Group: (i) time to execute activity A, (ii) angular and cartesian variables, such as position, velocity and acceleration, (iii) dynamic variables, such as torques and (iv) derived metrics, such as mechanical energy spend and movement smoothness.

All measurements and activities will be performed in the same day and in the following chronologically order:
(1) BBT
(2) pROM measurements for shoulder
(3) aROM measurements for shoulder
(4) Reaching and transporting exercises with and without body movement visualization, or vice-versa
(5) BBT
(6) aROM measurements for shoulder
(7) Reaching and transporting exercises with and without body movement visualization, or vice-versa

All steps will be performed without Kinesio tape. A short practice period before starting step 4 will be considered and short breaks between the different activities will be allowed. The total duration of the intervention will be approximately of 1 hour.
Besides the visual and auditory biofeedback from the virtual reality tracking and measuring system, participants will receive encouragement from therapists and general verbal performance feedback in order to engage them as much as possible and to increase their active participation and motivation.
Control group
Active

Outcomes
Primary outcome [1] 305074 0
Gross manual dexterity assessed using the Block and Box test
Timepoint [1] 305074 0
Pre- and immediately post-treatment application (primary endpoint)
Primary outcome [2] 305075 0
Time to complete the virtual task using a motion tracking camera and a PC
Timepoint [2] 305075 0
Pre- and immediately post-treatment application (primary endpoint)
Primary outcome [3] 305489 0
Shoulder range of motion assessed using a goniometer and also a motion tracking camera and PC
Timepoint [3] 305489 0
Pre- and immediately post-treatment application (primary endpoint)
Secondary outcome [1] 344099 0
Hand movement smoothness during execution of the virtual task using a motion tracking camera and a PC
Timepoint [1] 344099 0
Pre- and immediately post-treatment application
Secondary outcome [2] 345435 0
Angular variables (position, velocity and acceleration) during execution of the virtual task using a motion tracking camera and a PC
Timepoint [2] 345435 0
Pre- and immediately post-treatment application
Secondary outcome [3] 345436 0
Rotational forces (torques) to perform the virtual task using a motion tracking camera and a PC
Timepoint [3] 345436 0
Pre- and immediately post-treatment application
Secondary outcome [4] 345662 0
Cartesian variables (position, velocity and acceleration) during execution of the virtual task using a motion tracking camera and a PC
Timepoint [4] 345662 0
Pre- and immediately post-treatment application
Secondary outcome [5] 345923 0
Energy expenditure to perform the virtual task using a motion tracking camera and a PC
Timepoint [5] 345923 0
Pre- and immediately post-treatment application

Eligibility
Key inclusion criteria
-Be a patient of CRIT-Saltillo
-With a medical diagnosis of cerebral palsy
-With a GMFC between I and III
-Normal cognitive ability
-Submit the "Informed Consent" signed before the study
Minimum age
7 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Allergies to KINESIOTAPE®
- Ingestion of some type of drug or controlled medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Selected patients will be randomized and divided by a computer into two groups: Control Group and Treatment Group.
The Control Group will NOT have kinesio tape application and will receive the control treatment described in Step 3.
The Treatment group will have kinesio tape application and will receive the intervention treatment described in Step 3.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
To discard the established null hypotheses, the statistical F value for each of the independent variables will be calculated. This will be done through an analysis of variance with repetitive measures in the phase factor. Subsequently, and only when the result is significant, a multiple comparison test will be carried out. In all the analyzes a level of significance of p <0.5 would be considered. The software to be used will be R.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2018
Actual
8/05/2018
Date of last participant enrolment
Anticipated
31/05/2018
Actual
1/06/2018
Date of last data collection
Anticipated
Actual
1/06/2018
Sample size
Target
30
Accrual to date
Final
26
Recruitment outside Australia
Country [1] 9660 0
Mexico
State/province [1] 9660 0
Coahuila/Saltillo

Funding & Sponsors
Funding source category [1] 298904 0
Other
Name [1] 298904 0
Center for Rehabilitation and Inclusion Teleton (CRIT)
Country [1] 298904 0
Mexico
Funding source category [2] 298905 0
Other
Name [2] 298905 0
Center for Research and Advanced Studies of the IPN
Country [2] 298905 0
Mexico
Primary sponsor type
Other
Name
Center for Research and Advanced Studies of the IPN (CINVESTAV)
Address
Zona Industrial, 25900 Ramos Arizpe, Saltillo
Country
Mexico
Secondary sponsor category [1] 298119 0
Other
Name [1] 298119 0
Center for Rehabilitation and Inclusion Teleton (CRIT)
Address [1] 298119 0
Blvd. Carlos Abedrop Dávila 2901, Nuevo Centro Metropolitano de Saltillo, 25020, Saltillo
Country [1] 298119 0
Mexico

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299846 0
Ethics Committee (EC) of the Center for Rehabilitation and Inclusion Teleton (CRIT)
Ethics committee address [1] 299846 0
Blvd. Carlos Abedrop Dávila 2901, Nuevo Centro Metropolitano de Saltillo, 25020, Saltillo
Ethics committee country [1] 299846 0
Mexico
Date submitted for ethics approval [1] 299846 0
12/01/2018
Approval date [1] 299846 0
16/01/2018
Ethics approval number [1] 299846 0
6-2017

Summary
Brief summary
General Purpose
To quantify the immediate effect of the application of neuromuscular bandage on the shoulder in children with cerebral palsy and the effect of body movement visualization through and avatar, measuring kinematic and kinetic parameters, and performance metrics with a novel, non-invasive measurement tool and during the execution of virtual tasks.
Specific Objectives
Monitor and evaluate kinematic parameters of the upper limb in real time and during the transport of virtual objects with and without visualization of body movements, with and without the application of the neuromuscular bandage on the shoulder, using the measurement tool.
Monitor and evaluate kinetic parameters of the upper limb in real time and during the transport of virtual objects with and without visualization of body movements, with and without the application of the neuromuscular bandage on the shoulder, using the measurement tool.
Monitor and evaluate performance metrics when transporting virtual objects from a starting point to a final one with and without visualization of body movements, with and without the application of the neuromuscular bandage on the shoulder, using the measurement tool.
Analyze and compare the results obtained when transporting different virtual objects with and without visualization of body movements, with and without the application of the neuromuscular bandage on the shoulder.
Hypothesis
The use of a proposed measurement tool allows in real time to perform the following actions:
-Measure ranges of shoulder movement: a) abduction-adduction, b) flexion-extension and c) internal-external rotation, in children with cerebral palsy.
-Measure the rotational forces (torques) and energy consumption of the upper limb during the transport of virtual objects in children with cerebral palsy.
-Measure the smoothness and speed of hand movement in children with cerebral palsy during the transport of virtual objects.
-Measure the transport time of virtual objects located in different positions, in children with cerebral palsy.
The use of a tool also allows, through the comparison of the results, to do the following:
-Quantify the immediate effect of the application of the KT on the shoulder and body visualization movement over the range of movement of the shoulder: a) abduction-adduction, b) flexion-extension and c) external-internal rotation.
-Quantify the immediate effect of the application of the KT on the shoulder and body visualization movement on the rotating forces (torques) and energy consumption during the transport of virtual objects.
-Quantify the immediate effect of the application of the KT on the shoulder and body visualization movement on the softness and speed of the hand movement during the transport of virtual objects.
-Quantify the immediate effect of the application of the KT on the shoulder and body visualization movement on the transport time of virtual objects.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2484 2484 0 0
/AnzctrAttachments/374674-Carta Aceptación Protocolo_Ingles_Español.pdf (Ethics approval)

Contacts
Principal investigator
Name 81754 0
Prof Nadia Vanessa Garcia Hernandez
Address 81754 0
CINVESTAV, Zona Industrial, 25900 Ramos Arizpe, Saltillo
Country 81754 0
Mexico
Phone 81754 0
+528444389600
Fax 81754 0
Email 81754 0
nadia.garcia@cinvestav.mx
Contact person for public queries
Name 81755 0
Dr Raúl Díaz González Santibáñez
Address 81755 0
CRIT, Blvd. Carlos Abedrop Dávila 2901, Nuevo Centro Metropolitano de Saltillo, 25020, Saltillo.
Country 81755 0
Mexico
Phone 81755 0
+528444383838
Fax 81755 0
Email 81755 0
diaz@teleton-coa.org.mx
Contact person for scientific queries
Name 81756 0
Prof Nadia Vanessa Garcia Hernandez
Address 81756 0
CINVESTAV, Zona Industrial, 25900 Ramos Arizpe, Saltillo
Country 81756 0
Mexico
Phone 81756 0
+528444389600
Fax 81756 0
Email 81756 0
nadia.garcia@cinvestav.mx

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes García-Hernández, N & Corona-Cortés, J & García-Fu... [More Details] 374674-(Uploaded-26-03-2019-10-02-19)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.