Modelling and AI Using Sensor Data to Personalise REHABilitation Following Joint Replacement

Study Overview
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Brief Summary
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This study aims to determine a volunteer's gait objectively after surgery, when signed off from the consultant and physiotherapist. This will identify any gait deficiencies using simple traffic light coding, using GaitSmart, a CE Marked Class 1M Medical Device. Volunteers chosen for the intervention programme, a set of exercises to improve gait deficiencies identified in the report. All the exercises will be standard one already used within the NHS. The objectives are to compare the outcomes from the intervention group with the Standard of Care group, in terms of gait and PROMS and from this determine the clinical and economic benefits of the intervention.

Detailed Description
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This study aims to determine a volunteer's gait objectively after surgery, when signed off from the consultant and physiotherapist. This will identify any gait deficiencies using simple traffic light coding, using GaitSmart, a CE Marked Class 1M Medical Device. All volunteers in the intervention group will be provided with a copy of their report. Protocol for SoC group SoC volunteers receive a GaitSmart test at their first appointment but are not given their report. Questionnaires to record Volunteer reported outcome measures (PROMS) include: Oxford hip score (OHS) or Oxford knee score (OKS) plus the Euroqol questionnaire (EQ5D-5D) are completed. SoC volunteers return at week 15 for a second test but are not given their report. Questionnaires to record Volunteer reported outcome measures (PROMS) include: Oxford hip score (OHS) or Oxford knee score (OKS) plus the Euroqol questionnaire (EQ5D-5D) are completed. Protocol for GaitSmart intervention group GaitSmart intervention group have the procedure explained to them at the first appointment. All exercises have the volunteer standing or sitting and are chosen from exercises already provided by the NHS. Each volunteer will get a subset of these. The nurse will ensure volunteers can perform the exercises before leaving the session. GaitSmart test performed at weeks 6, 9, 12 and 15. The report is provided plus six personalised exercises. The nurse will check they are able to perform the tests at each visit. Those not suitable will be struck off the list. Questionnaires to record Volunteer reported outcome measures (PROMS) will be completed at weeks 6 and 15.

Official Title
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Digital Health: Modelling and Artificial Intelligence Using Sensor Data to Personalise REHABilitation Following Joint Replacement

Conditions
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Arthroplasty Complications

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion: The subject must provide written informed consent. Subject is scheduled for primary Total Knee replacement / Total Hip replacement within the next 30 days. Subject is considered skeletally mature. Subject is willing, able, and plans to perform the activities associated with the study. Unilateral or bilateral hip or knee replacement volunteers free of moderate to severe pain in the contralateral limb. Signed off at 6 weeks by physiotherapist. Exclusion: Will not be a resident living within the catchment area for Norfolk & Norwich University hospital for at least 6 months post-surgery. Undertaking the surgery as a private patient. Patients who, in the opinion of the clinical staff, do not have capacity to consent. Patients who are pregnant. Unable to understand written and spoken English. Patient who is currently enrolled in another interventional trial involving surgery, exercise or rehabilitation. Any neurological condition that affects movement.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise<br>Personalised exercise programme is provided to the exercise group. | Other: Exercise<br>* A set of exercises are provided to each patient.<br>|
| No Intervention: No Intervention<br>This group of patients will receive no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective change in gait kinematics | Change in a patient's gait measured objectively using Gaitsmart | 15 weeks post op | 
| Subjective change in gait | Change in a patient's Oxford hip or knee score | 15 weeks post op | 
| Quality of life changes | Change in a patient's Quality of Life score (EQ5D) | 15 weeks post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Replacement Rehabilitation