RecruitingACTRN12616001241426

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

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.


Sponsor

Nicholas Noye

Enrollment

100 participants

Start Date

Mar 19, 2020

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 15 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a smartphone app alongside a standard shoulder rehabilitation program leads to better recovery after a shoulder dislocation. Patients will be randomly assigned to use the app or not, and their shoulder stability and function will be measured over 18 months. You may be eligible if: - You are between 15 and 60 years old - You have had a shoulder dislocation (anterior type) diagnosed within the past four weeks - You are being treated without surgery (conservative management) - You own a smartphone You may NOT be eligible if: - You need surgery for your shoulder dislocation - The app's rehabilitation exercises are not clinically appropriate for you - You do not have access to a smartphone - You are unable to safely exercise without direct supervision Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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”


Locations(1)

Toowoomba Hospital - Toowoomba

QLD, Australia

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ACTRN12616001241426


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