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

Arthroplasty Complications Clinical Trial

— MAPREHAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289025
• Other study ID #: Dig Health01
• Status: Completed
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: February 24, 2022

Study information

• Verified date: April 2022
• Source: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 24, 2022
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion:

1. The subject must provide written informed consent.

2. Subject is scheduled for primary Total Knee replacement / Total Hip replacement within the next 30 days.

3. Subject is considered skeletally mature.

4. Subject is willing, able, and plans to perform the activities associated with the study.

5. Unilateral or bilateral hip or knee replacement volunteers free of moderate to severe pain in the contralateral limb.

6. Signed off at 6 weeks by physiotherapist.

Exclusion:

1. Will not be a resident living within the catchment area for Norfolk & Norwich University hospital for at least 6 months post-surgery.

2. Undertaking the surgery as a private patient.

3. Patients who, in the opinion of the clinical staff, do not have capacity to consent.

4. Patients who are pregnant.

5. Unable to understand written and spoken English.

6. Patient who is currently enrolled in another interventional trial involving surgery, exercise or rehabilitation.

7. Any neurological condition that affects movement.

Related Conditions & MeSH terms

• Arthroplasty Complications

Intervention

Other:
• Exercise
A set of exercises are provided to each patient.

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk

Sponsors (3)

Lead Sponsor	Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust	Dynamic Metrics Ltd, University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective change in gait kinematics	Change in a patient's gait measured objectively using Gaitsmart	15 weeks post op
Primary	Subjective change in gait	Change in a patient's Oxford hip or knee score	15 weeks post op
Primary	Quality of life changes	Change in a patient's Quality of Life score (EQ5D)	15 weeks post op