Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000549527
Ethics application status
Approved
Date submitted
28/04/2015
Date registered
28/05/2015
Date last updated
4/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual Rehabilitation of balance using Microsoft Kinect Sensor vs. Traditional Rehabilitation of Balance in stroke patients. A PseudoRandom Clinical Trial.
Scientific title
Balance rehabilitation using Microsoft Kinect Sensor: does it improve balance in patients with reduced mobility after stroke and the effect on patient and therapist satisfaction
Secondary ID [1] 286600 0
None
Universal Trial Number (UTN)
U1111-1169-6030
Trial acronym
EPIK

Entrenamiento Para la Independencia con Kinect
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance in stroke patients 294899 0
Condition category
Condition code
Stroke 295150 295150 0 0
Ischaemic
Stroke 295151 295151 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 295270 295270 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are divided in two groups: TRAD (traditional rehabilitation of balance) and EPIK (virtual rehabilitation of balance).
The "TRAD" group trains the balance using a traditional balance protocol of exercices that consists of 15 sessions along 6 weeks.
Each session consist of 30 min. of balance training.
In each session there are one patient an two therapists. One therapist trains the patient and the other supports the patient in their unbalance moments when they happen. It's very important for patiens to feel good and safe during the training session.

Several destabilizing materials are used: exercise resistance band, mat, Fitball, Bosu, medicine balls, while patients perform the specific balance exercices.

The EPIK group follows the same protocol but intercalates balance exercices using a virtual game that uses the Microsoft Kinect Sensor as a movement capture system (MoCaps). About 50% of the 30 min. of the session, the patients are interacting with the virtual game.

It is not applicable the use of strategies to monitor adherence.
Intervention code [1] 291721 0
Rehabilitation
Comparator / control treatment
Traditional Rehabilitation of the balance.
15 sessions along 6 weeks.
Each session consist of 30 min. of balance training.
Several destabilizing materials are used: exercise resistance band, mat, Fitball, Bosu, medicine balls, while patients perform the specific balance exercices.
Control group
Active

Outcomes
Primary outcome [1] 294914 0
Balance

To measure the balance it is used these test:

Force Platform
Tinetti Balance Scale
Berg Balance Scale
Timepoint [1] 294914 0
Before Control Period
After Control Period (Baseline, 6 weeks)
After Intervention (6 weeks)
Secondary outcome [1] 314328 0
Satisfaction with Two Rehabilitation Therapies

A satisfaction test is used to assess satisfaction. A test devised specifically for this study using a Likert Scale.
Timepoint [1] 314328 0
6 weeks after intervention starts

Eligibility
Key inclusion criteria
People with stroke
Minimum age
45 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Imposibility to perform some of the Balance Evaluation Tests

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients that sign the informed consent and perform the balance evaluation test, are included in the sample.
The patients are allocated to TRAD group or to EPIK group using the pseudo-random method of Minimization using as confounders: age, gender, side afected by stroke, results from the balance evaluation tests, and results from the computer abilities test.
Each patients has a code, and the name is concealed.
The code of each patient and their associated values of confounders factors are introduced into the MinimPy software aplication that assigns automaticaly each patient to one of the two groups (TRAD or EPIK). The person who introduce the data into MinimPy software does not know the name of the patients, he only knows the code. This person is not the same that determines if a subject was eligible for inclusion in the trial.
Therefore the person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The MinimPy software aplication (sourceforge.net/projects/minimpy) is used to allocate patients using the confounders enumerated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
- Statistical Methods 1:
* Dependant variable: balance, measured by force platform, continous variable
* Independant variables: time and group
The normality of the dependent variables obtained from the force platform will be analized using the Shapiro Wilk test. If normality is assumed, a two-way analisys of variance with repeated measures on time will be applied. Post hoc analisys will be performed using the Bonferroni test. If normality is not assumed, comparisons will be done using non parametric procedures. Values will be expresed as mean and standard deviation for normal variables and as median and interquartile range for non normal variables.

*Dependant variables: balance, measured by questionaires, ordinal variable
*Independant variable: time and group
In order to perform the within subjects comparisons Wilcoxon test will be applied. In respect to between subjects comparisons U Mann Whitney will be applied. Values will be expresed as median and interquartile range

*Dependant variables: satisfaction, measured by questionaires, ordinal variable
*Independant variable: group
The U Mann Whitney will be used to compare satisfaction level between both experimental groups. Values will be expresed as median and interquartile range.

In all procedures a level of significance of 0.05 will be considered.

A total of 19 patients have been recruited to this study. There has been no sample size calculation because we depend of the interest of patients in participate in this study. For the same reason there has been no considerations about the number of participants needed to achieve study objectives.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/03/2015
Actual
9/03/2015
Date of last participant enrolment
Anticipated
20/03/2015
Actual
27/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
19
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 6847 0
Spain
State/province [1] 6847 0
Valladolid

Funding & Sponsors
Funding source category [1] 291167 0
Self funded/Unfunded
Name [1] 291167 0
Country [1] 291167 0
Primary sponsor type
Charities/Societies/Foundations
Name
ASPAYM CASTILLA Y LEON FOUNDATION
Address
CALLE TREVINO, 74
47008
VALLADOLID
SPAIN
Country
Spain
Secondary sponsor category [1] 289847 0
University
Name [1] 289847 0
UNIVERSIDAD EUROPEA MIGUEL DE CERVANTES
Address [1] 289847 0
CALLE PADRE JULIO CHEVALIER, 2
47012-Valladolid
Country [1] 289847 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292742 0
Ethical Committee of the Aspaym Castilla y Leon Foundation
Ethics committee address [1] 292742 0
C/Trevino, 74
47008-Valladolid
Ethics committee country [1] 292742 0
Spain
Date submitted for ethics approval [1] 292742 0
Approval date [1] 292742 0
06/03/2015
Ethics approval number [1] 292742 0

Summary
Brief summary
The aim of this study is to compare two rehabilitation therapies: a traditional rehabilitation therapy of balance vs. a virtual rehabilitation therapy of balance in stroke patients and evaluate the outcomes in patients' balance and in their satisfation.
Trial website
Trial related presentations / publications
Title: EPIK: A Virtual Rehabilitation Platform Devised to Increase Self-Reliance of People with Limited Mobility

Authors: Sonia Garrote, Azael J. Herrero, Miguel Pedraza-Hueso, Carlos Gonzalez-Gutierrez, Maria V. Fernandez-San Roman, F.J. Diaz-Pernas, Hector Menendez, Cristina M. Ferrero, Mario Martinez-Zarzuela

Published in the proceedings of the Conference: International Conference on Information and Communication Technologies for Ageing Well and e-Health.

Date: May-2015

Page Numbers: 6
Public notes

Contacts
Principal investigator
Name 56822 0
Miss Sonia Maria Garrote Fernandez. Universidad Europea Miguel de Cervantes.
Address 56822 0
Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Country 56822 0
Spain
Phone 56822 0
+34 630538615
Fax 56822 0
Email 56822 0
[email protected]
Contact person for public queries
Name 56823 0
Miss Sonia Maria Garrote Fernandez
Address 56823 0
Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Country 56823 0
Spain
Phone 56823 0
+34 630538615
Fax 56823 0
Email 56823 0
[email protected]
Contact person for scientific queries
Name 56824 0
Miss Sonia Maria Garrote Fernandez
Address 56824 0
Universidad Europea Miguel de Cervantes.
C/Padre Julio Chevalier, 2
47012-Valladolid
Country 56824 0
Spain
Phone 56824 0
+34 630538615
Fax 56824 0
Email 56824 0
[email protected]

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No Supporting Document Provided



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