Comparing Gamification With Remote Monitoring Against Standard Rehabilitation, for Patients After Arthroscopic Subacromial Decompression Surgery
Condition: Shoulder Impingement Syndrome; Subacromial Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

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:

        1. 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.

        2. 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.

      Patient activation describes the knowledge, skills and confidence a person has in managing
      their own health and health care. Intervening to increase activation can improve a patient's
      engagement and health outcomes. This is an important factor in helping patients manage their
      health (Kings Fund 2015). As a part of this study we will quantify patient engagement.
      Through this we can develop and validate a new tool to comprehensively measure patient
      outcomes using four domains. These will be Patient reported pain and function (P), shoulder
      range of movement i.e.

      Kinematics (K), patient activation or engagement (E) and patient experience (X).

      Gamification:

      Traditional evaluation of the patient's range of motion usually occurs in a clinic, often
      using subjective and informal methods of angle measurement. This has the potential to create
      discrepancies in findings between clinicians. To reduce the use of healthcare resources, make
      the clinical assessment more convenient for the patient, to improve the quality of the
      information collected and the assessment conducted, electronic measurement has the potential
      to perform repeatable validated objective results.

      If combined with appropriate principles of gamification, these measurements can become a part
      of the rehabilitation process with potentially faster clinical improvement and comprehensive
      analysis of patient generated outcomes. In light of this, there has been a wave of support
      for the implementation of gaming elements in healthcare technologies.

      'Gamification' involves the incorporation of game mechanics in a non-game setting and a
      tailored user interface for better learning which encourages engagement (King 2013). Reward
      systems, competition and immediate feedback improve user experience and have been implemented
      in healthcare related fields where patients have become a niche target group (Lin 2013). This
      may in turn increase patient activation allowing them to manage their own health.

      MIRA:

      MIRA Rehab is a company who has developed software designed for the rehabilitation of medical
      conditions.

      Combined with a Microsoft Kinect sensor it accurately traces the range of motion in the
      shoulder. MIRA uses games which are built based upon the best clinical practice and expertise
      from specialist clinicians. The MIRA programme enables patients to progress through different
      levels within the games whilst engaging in their rehabilitation programme.

      Research Design and Methodology:

      Methodology:

      90 patients will be recruited to a 3 month rehabilitation programme following a standard
      subacromial decompression

      +/biceps tenotomy for impingement syndrome. Patients will be randomised into two groups:

        1. Standard postoperative physiotherapy regime without the use of accessory software
           (Treatment as usual Group).

        2. Postoperative regime of physiotherapy plus Exergames utilizing principles of
           gamification.

      Power calculation:

      A sample size calculation was performed using Oxford Shoulder Score (OSS) sample data
      collected on patients previously undergoing arthroscopic subacromial decompression. [Alpha
      error set at 0.05, and beta error at 0.8, mean difference of 5 points12 in the OSS, standard
      deviation 6.96] Based upon this, a sample size of 32 patients in each group would be
      required.

      A second sample size calculation was performed based on the disabilities of arm shoulder and
      hand (DASH) outcome measure. [Alpha error set at 0.05, and beta error at 0.8, mean difference
      of 15 points in the DASH13, standard deviation 23] Based upon this, a sample size of 37
      patients in each group would be required.

      Therefore, a target of 45 patients per group was chosen to allow for some participants
      withdrawing from the study (20%).

      Treatment as usual Group:

      Patients will attend physiotherapy on a weekly basis for assessment. They will be assessed
      for progression and be provided with a home exercise program. Range of motion in their
      shoulder will be collected on a weekly basis using the MIRA technology. Patients will be
      required to complete an exercise diary documenting the exercises performed as well as
      duration and frequency.

      Treatment as usual plus Exergames Group:

      Prior to commencing the study the physiotherapists will set up and initially demonstrate the
      Exergames to the intervention participants in the home setting. This will ensure the safety
      of the patients and address any technological issues that may arise. Patients will attend
      physiotherapy on a weekly basis as well as partaking in a set of tailored Exergames to play
      in the home system. The MIRA software will record the patient engagement with the system
      including number of sessions and duration of play. Patients will also be asked to complete an
      exercise diary.

      VISIT SUMMARY

      Baseline (Clinic Consultation):

      Patient's eligibility to participate in the study will be assessed; inclusion/ exclusion
      criteria must be met. The Patient Information Sheet will be given to the patient when they
      are listed for surgery. Prior to their surgery date, the patient will be contacted by a
      member of the research team, to see if they would like to participate in the study. Patient
      will be asked to give their consent to the study on the day of surgery. Past medical history
      will be reviewed and patient demographics will be documented. Relevant questions and scoring
      will be taken for baseline reference.

      + 24 hours (following baseline assessments) The patient reported outcome measures
      questionnaires will be repeated by all patients.

      Day 1 Patient attends hospital for surgical treatment. Confirmation of study consent must be
      confirmed. A study diary will be dispensed to patient. Study coordinator will give full
      explanation regarding completion of the diary.

      Day 7,14,21,28,35,42,49,56,63,70,77.

      Patient must attend physiotherapy clinic at day 7,14,21,28,35,42,49,56,63,70,77. A scheduled
      visit window to allow flexibility is +/- 2 days. Patient is to continue with their
      post-operative physiotherapy regime depending on the treatment group they have been
      randomised. Range of Movement will be assessed and documented by the research
      physiotherapist. Each patient diary will be reviewed and assessed.

      Day 84/85 Patient diary will be reviewed and returned. On completion of the 12 week programme
      all patients (N=90) will complete all outcome questionnaires, Patients randomised to
      Exergames arm will complete a Systems Usability score for the MIRA software. Range of
      movement will be recorded by MIRA and documented by the research physio-therapist.

      Day 365 One year post surgery all patients (N=90) will complete the scoring questionnaires.
    

Intervention name(s): Exergames- Laptop and MIcrosoft Kinect
Intervention type(s): Device
Intervention description(s): Following surgery each patient will have a set of games for them to play using their affecting shoulder. These games have been designed by physiotherapists and shoulder surgeons to improve the functional range of movement in their shoulder
Other intervention name(s): Microsoft Kinect; MIRA Rehab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: shoulder; impingement; rehabilitation; physiotherapy; gamification; activation; engagement