Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001252202
Ethics application status
Approved
Date submitted
5/07/2018
Date registered
25/07/2018
Date last updated
25/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of virtual reality in functionality when used in physiotherapeutic training of patients with total hip arthroplasty compared to conventional treatment. Randomized Clinical Trial.
Scientific title
Effectiveness of virtual reality in functionality when used in physiotherapeutic training of patients with total hip arthroplasty compared to conventional treatment. Randomized Clinical Trial.
Secondary ID [1] 295425 0
NONE
Universal Trial Number (UTN)
U1111-1211-1888
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total hip arthroplasty 308696 0
Condition category
Condition code
Musculoskeletal 307632 307632 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 307633 307633 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment sessions consisted of 10 sessions of 60 minutes each, 3 times a week and "one-on-one face-to-face", which consisted of: 10 minutes of warm wet compress in the area involved in total hip arthroplasty to 40oC , 10 minutes of static bicycle for patient tolerance (60% of the reserve of heart rate according to karvonen), 15 minutes of muscular strengthening exercises in which worked for the gluteus medius and greater in lateral decubitus with the leg flexed and extend them in both lower extremities, supine exercises called "bridge" and the work of abductors and adductors of the hip with different resistances depending on the patient's tolerance, together with these 10 minutes of gait training which consists in relearning the phases of the march in parallel bars. In addition to this, a 10-minute work on the Wii Board platform was applied to the experimental group, with the Wii Fit Plus videogame, specifically with the "Loose String" games, where the subject simulates a walk through a rope, tilting the body to the right and left alternately, and "Rio Abajo", game where the subject must move its center of gravity through both lower extremities on the Wii platform, with the aim of reaching a certain objective. All the intervention will be supervised by the physiotherapist, who will administer all the elements of the intervention.
Intervention code [1] 301749 0
Treatment: Devices
Intervention code [2] 301929 0
Rehabilitation
Comparator / control treatment
The treatment sessions consisted of 10 sessions of 60 minutes each, 3 times a week and one-on-one face-to-face, which consisted of: 10 minutes of warm wet compress in the area involved in total hip arthroplasty to 40oC , 10 minutes of static bicycle for patient tolerance (60% of the reserve of heart rate according to karvonen), 15 minutes of muscular strengthening exercises in which worked for the gluteus medius and greater in lateral decubitus with the leg flexed and extend them in both lower extremities, supine exercises called "bridge" and the work of abductors and adductors of the hip with different resistances depending on the patient's tolerance, together with these 10 minutes of gait training which consists in relearning the phases of the march in parallel bars. However, the control group did not perform training on the Wii platform.
Control group
Active

Outcomes
Primary outcome [1] 306617 0
Funcionality through Scoring in womac questionnaire
Timepoint [1] 306617 0
before and after finishing the 10 sessions of physiotherapy training
Secondary outcome [1] 349035 0
Balance through Berg Balance scale (BBS)
Timepoint [1] 349035 0
before and after finishing the 10 sessions of physiotherapy training
Secondary outcome [2] 349036 0
Weight load: The Wii Board platform will be used through the measurement of the weight distribution performed by the two lower extremities, expressed in percentage of weight load exerted by them during a stationary walk. The test to use is within the game Wii Fit Plus, under the name of "Test of 20 steps".
Timepoint [2] 349036 0
before and after finishing the 10 sessions of physiotherapy training
Secondary outcome [3] 349037 0
Distance traveled: Meters traveled in the 6-minute walk test (6MWT).
Timepoint [3] 349037 0
before and after finishing the 10 sessions of physiotherapy training

Eligibility
Key inclusion criteria
Subjects derived from traumatology of the HCSBA, with more than 50 years of age operated on with uncemented TCA (Information of clinical record), that present a month of postoperative evolution in the expectation of their first physiotherapeutic attention, which can maintain the biped and perform independent running with or without technical assistance. And those who accept and sign informed consent.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with less than 50 years of age, not enrolled in the HCSBA traumatology service, with vestibular and / or visual alterations. And those who do not accept and do not sign informed consent.

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)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Taking into account the study by Beaupré et al. in which they used a conventional physiotherapeutic treatment similar to our study, we established a difference of at least 11.9 points as the minimum clinically important difference
in the WOMAC questionnaire functionality. Therefore this data was taken to make our sample size calculation. It was found that for alpha= 0.05 (probability of committing type I error) and a statistical power of 80%; To detect a minimum difference of 11.9 points in the functionality items of the WOMAC questionnaire, with a minimum effect of 0.08, 35 patients are needed for each study group, ie a total of 70 patients to configure the sample of this study. In agreement with this, the authors of the present study have proposed as experimental hypothesis that there is a decrease of at least 11.9 points in the WOMAC questionnaire in the function item in the group treated with an exercise program that includes virtual reality compared to a conventional treatment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/07/2017
Date of last participant enrolment
Anticipated
Actual
15/08/2017
Date of last data collection
Anticipated
Actual
20/12/2017
Sample size
Target
70
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 10620 0
Chile
State/province [1] 10620 0
Santiago

Funding & Sponsors
Funding source category [1] 300013 0
Hospital
Name [1] 300013 0
clinical hospital san borja arriaran
Country [1] 300013 0
Chile
Funding source category [2] 300029 0
University
Name [2] 300029 0
University of the Americas
Country [2] 300029 0
Chile
Primary sponsor type
University
Name
University of the Americas
Address
Av. Manuel Montt 948, Providencia, Metropolitan Region
Country
Chile
Secondary sponsor category [1] 299399 0
Hospital
Name [1] 299399 0
clinical hospital san borja arriaran
Address [1] 299399 0
Av. Sta. Rosa 1234, Santiago, Metropolitan region,
Country [1] 299399 0
Chile

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300866 0
Scientific Ethics Committee Central Metropolitan Health Service
Ethics committee address [1] 300866 0
Ethics committee country [1] 300866 0
Chile
Date submitted for ethics approval [1] 300866 0
02/06/2017
Approval date [1] 300866 0
06/06/2017
Ethics approval number [1] 300866 0
048975

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2867 2867 0 0
/AnzctrAttachments/375507-autorizacion-comite.pdf (Ethics approval)

Contacts
Principal investigator
Name 85086 0
Mr Jonathan Zavala González
Address 85086 0
Av. Sta. Rosa 1234, Santiago, Metropolitan region,
Work Organisation: Clinical hospital San Borja Arriarán
Country 85086 0
Chile
Phone 85086 0
+56985483744
Fax 85086 0
Email 85086 0
[email protected]
Contact person for public queries
Name 85087 0
Diego Martínez Escobar
Address 85087 0
Av. Sta. Rosa 1234, Santiago, Metropolitan region,
Work Organisation: Clinical hospital San Borja Arriarán
Country 85087 0
Chile
Phone 85087 0
+56950828851
Fax 85087 0
Email 85087 0
[email protected]
Contact person for scientific queries
Name 85088 0
Jonathan Zavala González
Address 85088 0
Av. Sta. Rosa 1234, Santiago, Metropolitan region,
Work Organisation: Clinical hospital San Borja Arriarán
Country 85088 0
Chile
Phone 85088 0
+56985483744
Fax 85088 0
Email 85088 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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