Comparing Gamification With Remote Monitoring Against Standard Rehabilitation, for Patients After Arthroscopic Subacromial Decompression Surgery

NCT02705521 | Completed DMC

• 1 other identifier: IRAS 179371
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 3

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. 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. 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.

Conditions

Shoulder Impingement Syndrome; Subacromial Impingement Syndrome

Keywords

shoulder; impingement; rehabilitation; physiotherapy; gamification; activation; engagement

Outcome Measures

Primary Outcomes (1)

• Oxford shoulder score

  Patients will be assessed for a significant difference in the OSS at 3 at 12 months compared with the treatment as usual group.

  3 months and twelve months

Secondary Outcomes (4)

• 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

• Visual analogue Scale for pain (VAS)

  3 months and 12 months

• Shoulder range of movement

  3 months

Study Arms (2)

Treatment as usual group

NO INTERVENTION

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.

Treatment as usual plus Exergames group

EXPERIMENTAL

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

Interventions

Exergames- Laptop and MIcrosoft Kinect DEVICE

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

Also known as: Microsoft Kinect, MIRA Rehab

Treatment as usual plus Exergames group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• Northern Care Alliance NHS Foundation Trust: collaborator
• Royal Bolton Hospital NHS Foundation Trust: collaborator

Study Sites (3)

Royal Bolton Hospital

Bolton, Lancashire, BL4 OJR, United Kingdom

Location

Trafford General Hospital

Manchester, Lancashire, M45 5SL, United Kingdom

Location

Salford Royal Hospital

Manchester, Lancashire, M6 8HD, United Kingdom

Location

Related Publications (10)

• Bigliani LU, Ticker JB, Flatow EL, Soslowsky LJ, Mow VC. The relationship of acromial architecture to rotator cuff disease. Clin Sports Med. 1991 Oct;10(4):823-38.

  PMID: 1934099 BACKGROUND

• Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):138-60. doi: 10.1016/j.jse.2008.06.004. Epub 2008 Oct 2.

  PMID: 18835532 BACKGROUND

• Jordan KP, Kadam UT, Hayward R, Porcheret M, Young C, Croft P. Annual consultation prevalence of regional musculoskeletal problems in primary care: an observational study. BMC Musculoskelet Disord. 2010 Jul 2;11:144. doi: 10.1186/1471-2474-11-144.

  PMID: 20598124 BACKGROUND

• Olley LM, Carr AJ. The use of a patient-based questionnaire (the Oxford Shoulder Score) to assess outcome after rotator cuff repair. Ann R Coll Surg Engl. 2008 May;90(4):326-31. doi: 10.1308/003588408X285964.

  PMID: 18492399 BACKGROUND

• Maclean N, Pound P, Wolfe C, Rudd A. The concept of patient motivation: a qualitative analysis of stroke professionals' attitudes. Stroke. 2002 Feb;33(2):444-8. doi: 10.1161/hs0202.102367.

  PMID: 11823650 BACKGROUND

• King D, Greaves F, Exeter C, Darzi A. 'Gamification': influencing health behaviours with games. J R Soc Med. 2013 Mar;106(3):76-8. doi: 10.1177/0141076813480996. No abstract available.

  PMID: 23481424 BACKGROUND

• Lin RJ, Zhu X. Leveraging social media for preventive care-A gamification system and insights. Stud Health Technol Inform. 2012;180:838-42.

  PMID: 22874310 BACKGROUND

• Cloke DJ, Watson H, Purdy S, Steen IN, Williams JR. A pilot randomized, controlled trial of treatment for painful arc of the shoulder. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):17S-21S. doi: 10.1016/j.jse.2007.07.005.

  PMID: 18069016 BACKGROUND

• Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996 Jul;78(4):593-600.

  PMID: 8682827 BACKGROUND

• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

  PMID: 2868172 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Bibhas Roy, MB CHB MSC

  Central Manchester University Hospitals Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2016
• First Posted: March 10, 2016
• Study Start: March 29, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)