A Multi-centre, Randomised, Controlled Study Comparing Gamification With Remote Monitoring Against Standard Rehabilitation, for Patients After Arthroscopic Subacromial Decompression Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 71
- Locations
- 6
- Primary Endpoint
- Oxford shoulder score
Study Overview
Brief Summary
This randomised prospective controlled trial will investigate patients with impingement syndrome who undergo arthroscopic subacromial decompression. The intervention group will receive physiotherapy aided by automated sensor-based technology which will help them perform exergames and track their rehabilitation progress. The control group will be treated by standard physiotherapy protocols. The two groups will be compared using patient reported outcome measures and assessment of shoulder range of movement before and after the shoulder surgery.
Data will be collected on patient experience, engagement with the rehabilitation process and the usability of the sensor-based technology through the use exergames. This will guide development of methods to quantify patient activation and engagement.
Hypothesis:
- There will be a significant clinical difference in post-surgical improvement measured by patient reported outcomes when physiotherapy is aided by automated sensor-based technology to perform Exergames and track progress, compared to standard physiotherapy protocols.
- There will be a significant difference in post-surgical improvement in range of shoulder movement and patient improvement, measured by patient reported out-comes when physiotherapy is aided by automated sensor-based technology to perform exergames and track progress, compared to standard physiotherapy protocols.
Detailed Description
Background:
Musculoskeletal problems are one of the most common reasons for seeking medical advice, with estimates of up to 20% of adults annually consulting their general practitioner. The prevalence of shoulder problems in the population is approximately 2.5%(Jordon et al 2010). In 2012/13, there were over 7.1 million outpatient appointments for trauma and orthopaedics in England (accounting for 9.3% of all outpatient attendances) and over 4 million of these visits were followup after the initial consultation (Hospital Episode Statistics). The average cost for each outpatient follow up is £76. At a time when the NHS is under considerable financial burden we are constantly looking at ways and means of reducing the number of outpatient appointments and the length of time for which a patient required followup. By improving rehabilitation protocols patients may complete their recovery more rapidly which may reduce clinician patient face-to-face interactions. This may free up this valuable resource which can be directed towards more complex clinical requirements.
Patient Engagement:
One of the major factors that influence patient outcomes is their engagement with the rehabilitation program.
Rehabilitation professionals have long suspected that a patient's motivation plays an important role in determining the outcome of therapy, despite the lack of a clear definition of the phenomenon (Maclean et al. 2002). It is estimated that up to 65% of patients are non/partially adherent to their home exercise program (Meichenbaum 1987). Classically, patients have completed home exercise diaries. However, studies have suggested that these are often completed retrospectively. This may encourage patients to exaggerate the amount of activity performed. Hoelscher at al (1984), timed patients at home performing a relaxation exercise program and compared this to patient reported duration. They found that the latter tended to suggest a higher level of adherence. The Exergames programmes actively track patient interaction with the software. Each activity records the length of interaction, progress through rehabilitation allowing the clinician to have a clearer indication of patient engagement in rehabilitation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A diagnosis of impingement syndrome based upon history, clinical examination and radiological findings that require arthroscopic subacromial decompression.
- •The patient has access to the internet to allow for the remote monitoring element of the intervention.
- •The patient needs to be able to use the sensor based technology safely, as judged by the research team.
- •The patient is willing to consent to follow-up over a twelve month period.
- •The patient has capacity to consent to the study.
Exclusion Criteria
- •Aged less than 18 or greater than 70
- •Patients who are unwilling or unable to consent
- •Previous arthroscopic shoulder surgery
- •Patients undergoing radiotherapy
- •Patients with type 1 or type 2 diabetes
- •Patients not fit for general anaesthetic
- •Patients with significant cardiac dysfunction
- •Uncontrolled hypertension
- •Acute illness
- •History of stroke / neuromuscular conditions preventing the use of Exergames
- •Patient is currently enrolled in another clinical trial.
Outcomes
Primary Outcomes
Oxford shoulder score
Time Frame: 3 months and twelve months
Patients will be assessed for a significant difference in the OSS at 3 at 12 months compared with the treatment as usual group.
Secondary Outcomes
- The Disabilities of the Arm, Shoulder and Hand score(3 months and 12 months)
- The European Quality of Life 5 Dimensions (EQ5D)(3 months and 12 months)
- Shoulder range of movement(3 months)
- Visual analogue Scale for pain (VAS)(3 months and 12 months)