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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 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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cerebral palsy

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

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]

Gross manual dexterity assessed using the Block and Box test

Timepoint [1]

Pre- and immediately post-treatment application (primary endpoint)

Primary outcome [2]

Time to complete the virtual task using a motion tracking camera and a PC

Timepoint [2]

Pre- and immediately post-treatment application (primary endpoint)

Primary outcome [3]

Shoulder range of motion assessed using a goniometer and also a motion tracking camera and PC

Timepoint [3]

Pre- and immediately post-treatment application (primary endpoint)

Secondary outcome [1]

Hand movement smoothness during execution of the virtual task using a motion tracking camera and a PC

Timepoint [1]