Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001241426
Ethics application status
Approved
Date submitted
1/09/2016
Date registered
6/09/2016
Date last updated
20/03/2020
Date data sharing statement initially provided
20/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Smart phone applications in the conservative management of shoulder dislocation rehabilitation (SPACS): An orthopaedic trial in the efficacy of smart phone applications as an adjunct in the rehabilitation of shoulder dislocations
Scientific title
An RCT assessing the efficacy of smart phone apps in the conservative management of shoulder rehabilitation post dislocation in the male and female population between 15-60 years of age.
Secondary ID [1] 290059 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder dislocation 300114 0
Condition category
Condition code
Musculoskeletal 299997 299997 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 300051 300051 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 300073 300073 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
N.B. Location has been changed to Toowoomba Base Hospital, Darling Downs QLD - pending SSA approval. This passage should read as:

“ The intervention are of the trial will receive access to a smart phone application detailing their condition, prognosis and expected recovery time along with text and video content detailing their rehabilitation program, This program will be supervised by a physiotherapist (with at least 5 years experience) in conjunction with the treating surgeon/medical officer (senior and junior medical officers under the supervision of a senior consultant orthopaedics surgeon).

The exercises within the app. will be industry standardised rotator cuff and stability exercises such as "Codman circles", Active range of motion stretches, and strengthening exercises i.e. shoulder abduction with dumbbell or weight. each exercise will have explanatory text and a short video clip demonstrating the movements.

The application would also prompt/remind the patient to practice their rehabilitation exercises as well as give them feedback r.e. Their progress. The application will also serve as a method of data collection where as the patient will receive periodic questionnaires and requests for feedback - particularly the Oxford instability and stability questionnaires - to track their progress.

The application will be free to the patient and there will be regular follow-up and supervision with clinicians and allied health. The patient will be required to pass a supervised program with the departments physiotherapist before being approved for individual rehabilitation exercises via the application.

The patient will have follow up at one week post injury - by which the patient will be assessed by the physiotherapist and medical officer and the application introduced. Their will then be a three, six and potentially twelve and twenty four week follow-up. These follow-up will depend on the patients adherence to the treatment plan i.e. the trial drop out rate. If the Patients delete the app. and no longer respond to emails at 24 weeks then follow-up may be lost.

These follow-up session will be within the Darling Downs Health service.

There will be no personalisation of the intervention meaning that if the rehabilitation program derived on the application is not suitable the patient will not be eligible for the trial.

Adherence will be assessed according to the response from the regular periodic questionnaires and patient feedback.

N.B. The rehabilitation program and information provided by the app will be created/designed in conjunction with the senior orthopaedic physiotherapist and Consultant orthopaedic surgeon at Toowoomba Base Hospital as well as being referenced with empirical evidenced and industry approved standards”
Intervention code [1] 295782 0
Rehabilitation
Comparator / control treatment
The control group will receive the same questionnaires and follow-up without access to the smart-phone application. They will go through the usual rehabilitation as the intervention group but without access to the app.

Usual rehabilitation usually entails a one week out patients appointment with an orthopaedic clinic followed by weekly physiotherapy for 3-6 weeks depending on the patients progress and compliance. The exercises used are ROM, proprioception and strengthening exercises. There is no set guideline of pathway r.e. which exercise should be used but this will be established prior to recruitment with the assistance/cooperation of the physiotherapy departments. there will be 2-4 exercises for 1) range of motion, 2) proprioception, 3) strength and prevention. The details of which will be decided in concordance with the senior physiotherapists at each department to ensure all participants are receiving the same rehabilitation program.
Control group
Active

Outcomes
Primary outcome [1] 299484 0
shoulder rehabilitation and stability measured by the Constant, Oxford stability and Oxford instability scoring systems

Timepoint [1] 299484 0
0, 1, 3, 6, 12, 24, 52, 76 weeks
Secondary outcome [1] 327301 0
Concurrent re-dislocations of the joint initially treated - this will be assessed via patient reporting and or medical records if available to confirm Patient reports.
Timepoint [1] 327301 0
Minimum six months, ideally twelve to eighteen months post initial injury

Eligibility
Key inclusion criteria
Males and females within the ages of 15-60 years that have a radio logically or clinically diagnosed anterior dislocation of either shoulder within four weeks of beginning the trial
Minimum age
15 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-conservative management I.e. Surgery
If the Rehabilitation detailed within the application is not suitable for the patient including not being clinically indicated, patient not having access to a smart phone and the patient not able to practice rehabilitation exercises unsupervised

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation - computer softwares
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/03/2020
Actual
Date of last participant enrolment
Anticipated
31/07/2021
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
100
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16150 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 28583 0
4350 - South Toowoomba
Recruitment postcode(s) [2] 29679 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 294447 0
Self funded/Unfunded
Name [1] 294447 0
Nicholas Noye
Country [1] 294447 0
Australia
Primary sponsor type
Individual
Name
Nicholas Noye
Address
Toowoomba Base Hospital, Pechey St, South Toowoomba, QLD 4350
Country
Australia
Secondary sponsor category [1] 293301 0
None
Name [1] 293301 0
None
Address [1] 293301 0
none
Country [1] 293301 0
Other collaborator category [1] 279186 0
Individual
Name [1] 279186 0
Ryan Beattie
Address [1] 279186 0
Princess Alexandra Hospital 199 Ipswich Rd, Woolloongabba QLD 4102
Country [1] 279186 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295877 0
The Prince Charles Hospital, Metro North Hospital and Health Service
Ethics committee address [1] 295877 0
The Prince Charles Hospital
Building 14
Rode Road
Chermside, Qld, 4032
Ethics committee country [1] 295877 0
Australia
Date submitted for ethics approval [1] 295877 0
30/10/2016
Approval date [1] 295877 0
11/08/2017
Ethics approval number [1] 295877 0
HREC/17/QPCH/128

Summary
Brief summary
The purpose of the SPACS study is to determine the efficacy of smart phone applications as adjuncts in the rehabilitation of orthopaedic patients, in this particular instance - shoulder dislocations.

Hypothesis: That smart-phone applications used in conjunction with an industry standardised rehabilitation program will improve patient outcomes represented by comparatively better Oxford stability and instability scores

Design: The study will be a simple RCT with two parallel cohorts. One with access to the app. and regular questionnaires and the other with questionnaires only. At the completion of 18 months data collection via the smart-phone apps. the scores between the two cohorts will be compared and analysed

Outcomes: the "constant", Orford stability score and Oxford instability scores will used to assess the patients recovery and rehabilitation before being compared to assess the efficacy of the intervention

Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1081 1081 0 0
/AnzctrAttachments/371414-Presentation.pdf

Contacts
Principal investigator
Name 68714 0
Dr Nicholas Noye
Address 68714 0
Toowoomba Base Hospital Pechey St, South Toowoomba QLD 4350
Country 68714 0
Australia
Phone 68714 0
+61 0436 011 566
Fax 68714 0
Email 68714 0
[email protected]
Contact person for public queries
Name 68715 0
Dr Nicholas Noye
Address 68715 0
Toowoomba Base Hospital Pechey St, South Toowoomba QLD 4350
Country 68715 0
Australia
Phone 68715 0
+61 0436 011 566
Fax 68715 0
Email 68715 0
[email protected]
Contact person for scientific queries
Name 68716 0
Dr Nicholas Noye
Address 68716 0
Toowoomba Base Hospital Pechey St, South Toowoomba QLD 4350
Country 68716 0
Australia
Phone 68716 0
+61 0436 011 566
Fax 68716 0
Email 68716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5784Study protocol    Up to date study protocol attached
5785Study protocol    371414-(Uploaded-07-11-2019-12-41-00)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.