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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)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02705521
Recruitment Status : Active, not recruiting
First Posted : March 10, 2016
Last Update Posted : March 17, 2020
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Salford Royal NHS Foundation Trust
Royal Bolton Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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:

  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 or disease Intervention/treatment Phase
Shoulder Impingement Syndrome Subacromial Impingement Syndrome Device: Exergames- Laptop and MIcrosoft Kinect Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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
Actual Study Start Date : March 29, 2016
Actual Primary Completion Date : March 14, 2017
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.

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


Locations
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United Kingdom
Royal Bolton Hospital
Bolton, Lancashire, United Kingdom, BL4 OJR
Trafford General Hospital
Manchester, Lancashire, United Kingdom, M45 5SL
Salford Royal Hospital
Manchester, Lancashire, United Kingdom, M6 8HD
Sponsors and Collaborators
Manchester University NHS Foundation Trust
National Institute for Health Research, United Kingdom
Salford Royal NHS Foundation Trust
Royal Bolton Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Bibhas Roy, MB CHB MSC Central Manchester University Hospitals Trust
Additional Information:
Publications:

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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02705521    
Other Study ID Numbers: IRAS 179371
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Manchester University NHS Foundation Trust:
shoulder
impingement
rehabilitation
physiotherapy
gamification
activation
engagement
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Syndrome
Rotator Cuff Injuries
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases