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Trial record 1 of 1 for:    A Multi-centre, Randomised, Controlled Study Comparing Gamification With Remote Monitoring Against Standard Rehabilitation, for Patients After Arthroscopic Subacromial Decompression Surgery (GAME)
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Comparing Gamification With Remote Monitoring Against Standard Rehabilitation, for Patients After Arthroscopic Subacromial Decompression Surgery (GAME)

This study is currently recruiting participants.
Verified July 2017 by Dominic Marley, Central Manchester University Hospitals NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT02705521
First Posted: March 10, 2016
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute for Health Research, United Kingdom
Salford Royal NHS Foundation Trust
Royal Bolton Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Dominic Marley, Central Manchester University Hospitals NHS Foundation Trust
  Purpose

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.

Condition Intervention
Shoulder Impingement Syndrome Subacromial Impingement Syndrome Device: Exergames- Laptop and MIcrosoft Kinect

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Controlled Study Comparing Gamification With Remote Monitoring Against Standard Rehabilitation, for Patients After Arthroscopic Subacromial Decompression Surgery

Resource links provided by NLM:


Further study details as provided by Dominic Marley, Central Manchester University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • The Disabilities of the Arm, Shoulder and Hand score [ Time Frame: 3 months and 12 months ]
    Patients will be assessed for a significant difference in the DASH score at 3 at 12 months compared with the treatment as usual group.

  • The European Quality of Life 5 Dimensions (EQ5D) [ Time Frame: 3 months and 12 months ]
    Patients will be assessed for a significant difference in the EQ5D at 3 at 12 months compared with the treatment as usual group.

  • Visual analogue Scale for pain (VAS) [ Time Frame: 3 months and 12 months ]
    Patients will be assessed for a significant difference in the EQ5D at 3 at 12 months compared with the treatment as usual group.

  • Shoulder range of movement [ Time Frame: 3 months ]
    Patients will be assessed using the MIRA software to see if there is a statistically significant difference in the cardinal ranges of motion in the shoulder joint


Estimated Enrollment: 90
Actual Study Start Date: April 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as usual group
Patients will attend physiotherapy on a weekly basis for assessment (standard physiotherapy). 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.
Experimental: Treatment as usual plus Exergames group
Patients will attend physiotherapy on a weekly basis for assessment (standard physiotherapy). Rather than use a home exercise program patients will be provided with a laptop computer and kinect sensor. they will use the new technology to play 'Exergames' each program will be tailored to the patients progress and patients can play the system as often as they wish. Patients will be required to complete an exercise diary documenting the exercises performed as well as duration and frequency.
Device: Exergames- Laptop and MIcrosoft Kinect
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 Names:
  • Microsoft Kinect
  • MIRA Rehab

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. A diagnosis of impingement syndrome based upon history, clinical examination and radiological findings that require arthroscopic subacromial decompression.
  2. The patient has access to the internet to allow for the remote monitoring element of the intervention.
  3. The patient needs to be able to use the sensor based technology safely, as judged by the research team.
  4. The patient is willing to consent to follow-up over a twelve month period.
  5. The patient has capacity to consent to the study.

Exclusion Criteria:

  1. Aged less than 18 or greater than 70
  2. Patients who are unwilling or unable to consent
  3. Previous arthroscopic shoulder surgery
  4. Patients undergoing radiotherapy
  5. Patients with type 1 or type 2 diabetes
  6. Patients not fit for general anaesthetic
  7. Patients with significant cardiac dysfunction
  8. Uncontrolled hypertension
  9. Acute illness
  10. History of stroke / neuromuscular conditions preventing the use of Exergames
  11. Patient is currently enrolled in another clinical trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705521


Contacts
Contact: William D Marley, MB BCH BAO 00447730619973 wmarley01@qub.ac.uk
Contact: James Wilson, MB CHB james@proms2.org

Locations
United Kingdom
Royal Bolton Hospital Not yet recruiting
Bolton, Lancashire, United Kingdom, BL4 OJR
Contact: James Wilson, MB CHB       james@[roms2.org   
Trafford General Hospital Recruiting
Manchester, Lancashire, United Kingdom, M45 5SL
Contact: Bibhas Roy, MB CHB MSC       broy@shouldersurgery.info   
Salford Royal Hospital Not yet recruiting
Manchester, Lancashire, United Kingdom, M6 8HD
Contact: Usman Butt, MB CHB       usmanbutt@doctors.net.uk   
Sponsors and Collaborators
Dominic Marley
National Institute for Health Research, United Kingdom
Salford Royal NHS Foundation Trust
Royal Bolton Hospital NHS Foundation Trust
Investigators
Principal Investigator: Bibhas Roy, MB CHB MSC Central Manchester University Hospitals Trust
  More Information

Additional Information:
Publications:

Responsible Party: Dominic Marley, Trauma and Orthopaedic Specialist trainee Year 6, Central Manchester University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02705521     History of Changes
Other Study ID Numbers: IRAS 179371
First Submitted: March 5, 2016
First Posted: March 10, 2016
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dominic Marley, Central Manchester University Hospitals NHS Foundation Trust:
shoulder
impingement
rehabilitation
physiotherapy
gamification
activation
engagement

Additional relevant MeSH terms:
Syndrome
Rotator Cuff Injuries
Shoulder Impingement Syndrome
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases