Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000603516
Ethics application status
Approved
Date submitted
27/05/2015
Date registered
9/06/2015
Date last updated
9/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of shoulder proprioception using the Microsoft Kinect sensor
Scientific title
Can the Microsoft Kinect sensor be used to assess the differences in shoulder proprioception between subjects with traumatic anterior shoulder instability and subjects with healthy, pain-free shoulders and between patients younger than 30 and older than 60 years of age?
Secondary ID [1] 286485 0
Nil
Universal Trial Number (UTN)
Trial acronym
KSPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic anterior instability of the shoulder 294691 0
Age-related differences in shoulder proprioception 295245 0
Condition category
Condition code
Musculoskeletal 294986 294986 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will be using the Microsoft Kinect sensor and a Virtual Reality headset to measure proprioception at the shoulder.

This will involve the subject being shown a video or image of a desired shoulder (and arm) position on the headset. They will be asked to try to copy this position themselves. The Kinect will record the subject's attempt and compare it to the desired position as shown on the headset.

Each participant will be tested only once in a single, one hour session. The testing session will be performed one on one by the student researcher in the team who is a medical student. As only one session is required per participant, strategies to monitor adherence do not apply.
Intervention code [1] 291579 0
Diagnosis / Prognosis
Intervention code [2] 291581 0
Treatment: Devices
Comparator / control treatment
We will compare the new test with two tests already described in the literature. One is called the "laser-pointer assisted angle-reproduction test" which uses a small laser strapped to the subject's wrist. With their eyes open, the subject points the laser at the 3 targets on the board in turn and concentrates on their position. They are then blindfolded and the examiner asks them to point at one of the target points in random order. The test is performed 3 times per target point, per arm, in both flexion and abduction. The examiner does not move the participant's arm at any stage. Each time the participant points the laser they must hold their arm in position long enough for the coordinates of the laser spot to be recorded.

The second test uses a goniometer. The subject is blindfolded and their arm is moved by the examiner into a target position and held for 10 seconds. It is then returned to the starting position. The subject has to actively return their arm to the target position. The subject's attempt will be compared to the target position to assess how accurately they can reproduce the joint position.
Control group
Active

Outcomes
Primary outcome [1] 294735 0
Mean difference, in degrees, between the desired angle of the shoulder and the actual angle of the shoulder.
Timepoint [1] 294735 0
Healthy controls will be tested at baseline.

Patients with anterior shoulder instability will be tested after they have received a formal diagnosis from a surgeon or sports physician. There is no restriction on length of time after diagnosis that the tests can be performed.
Primary outcome [2] 294736 0
Mean difference, in millimetres, between the desired position of the hand and the actual position of the hand.
Timepoint [2] 294736 0
Healthy controls will be tested at baseline.

Patients with anterior shoulder instability will be tested after they have received a formal diagnosis from a surgeon or sports physician. There is no restriction on length of time after diagnosis that the tests can be performed.
Secondary outcome [1] 313963 0
Pain and function measured by the Oxford Stability Score.
Timepoint [1] 313963 0
After a diagnosis of traumatic anterior instability by a surgeon or sports physician.
Secondary outcome [2] 313964 0
Stability, motion and function measured by the 1978 Rowe Score.
Timepoint [2] 313964 0
After a diagnosis of traumatic anterior instability by a surgeon or sports physician.

Eligibility
Key inclusion criteria
For the instability group we require participants under the age of 40 years who have had at least one documented incident of anterior subluxation or dislocation followed by the development of symptoms of anterior instability.
The control group will consist of adult volunteers with healthy shoulder under 30 years of age and over 60 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers in the control group will be excluded if they are currently experiencing shoulder pain or if they have ever had shoulder surgery.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/03/2015
Actual
30/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291053 0
University
Name [1] 291053 0
The Department of Surgery in the School of Clinical Sciences at Monash University
Country [1] 291053 0
Australia
Primary sponsor type
Individual
Name
A/Professor Simon Bell
Address
Melbourne Shoulder and Elbow Centre. 31 Normanby St Brighton Victoria 3186

Monash University. A/Professor of Orthopaedic Surgery
Country
Australia
Secondary sponsor category [1] 289736 0
Individual
Name [1] 289736 0
Dr Susan White
Address [1] 289736 0
Olympic Park Sports Medicine Centre
Olympic Boulevard
AAMI Park
Melbourne, Victoria 3004
Country [1] 289736 0
Australia
Secondary sponsor category [2] 290043 0
Individual
Name [2] 290043 0
Dr Jennifer Coghlan
Address [2] 290043 0
Melbourne Shoulder and Elbow Centre.
31 Normanby St
Brighton, Victoria 3186
Country [2] 290043 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292636 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 292636 0
Ethics committee country [1] 292636 0
Australia
Date submitted for ethics approval [1] 292636 0
Approval date [1] 292636 0
18/03/2015
Ethics approval number [1] 292636 0
CF15/821 - 2015000370

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 384 384 0 0
/AnzctrAttachments/368322-2015000370 Appr.pdf
Attachments [2] 385 385 0 0
/AnzctrAttachments/368322-PICF_KSPS_group 1_complete.doc
Attachments [3] 386 386 0 0
/AnzctrAttachments/368322-PICF_KSPS_group 2_complete.doc
Attachments [4] 387 387 0 0
/AnzctrAttachments/368322-questionnaire_KSPS.docx

Contacts
Principal investigator
Name 56346 0
A/Prof Simon Bell
Address 56346 0
Melbourne Shoulder and Elbow Centre. 31 Normanby St Brighton Victoria 3186

Monash University. A/Professor of Orthopaedic surgery.
Country 56346 0
Australia
Phone 56346 0
+61, 03, 95928028
Fax 56346 0
Email 56346 0
[email protected]
Contact person for public queries
Name 56347 0
Brooke Driessen
Address 56347 0
Melbourne Shoulder and Elbow Centre. 31 Normanby St Brighton Victoria 3186 Monash University.

Medical Student, Monash University.
Country 56347 0
Australia
Phone 56347 0
+61, 400650198
Fax 56347 0
Email 56347 0
[email protected]
Contact person for scientific queries
Name 56348 0
Brooke Driessen
Address 56348 0
Melbourne Shoulder and Elbow Centre. 31 Normanby St Brighton Victoria 3186 Monash University.

Medical Student Monash University.
Country 56348 0
Australia
Phone 56348 0
+61, 400650198
Fax 56348 0
Email 56348 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

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3987Plain language summaryNo Results: Active JPS test produced more frequent me... [More Details]

Documents added automatically
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