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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty Complications
• Intervention / Treatment: Other: Exercise

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk and Norwich University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Collaborators: University of East Anglia; Dynamic Metrics Ltd
• Investigators: Principal Investigator: Iain McNamara, MD, Clinical Research and Trials Unit (Norfolk and Norwich University Hospital, UK)

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): February 24, 2022

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Arthroplasty; Replacement Rehabilitation
• Other Study ID Numbers: Dig Health01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be shared by all partners. Only Norfolk and Norwich University Hospital will hold full patient data.
• IPD Sharing Time Frame: 0 to 28 months, which is 12 months after project completion.
• IPD Sharing Access Criteria: Access to the research dataset will be permitted via application to the CI's and sponsor.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No