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History of Changes for Study: NCT04289025
Modelling and AI Using Sensor Data to Personalise REHABilitation Following Joint Replacement (MAPREHAB)
Latest version (submitted April 1, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 27, 2020 None (earliest Version on record)
2 October 6, 2020 Study Status and Study Design
3 February 25, 2021 Recruitment Status, Study Status, Eligibility, Contacts/Locations and Oversight
4 November 12, 2021 Recruitment Status, Study Status and Contacts/Locations
5 April 1, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT04289025
Submitted Date:  February 27, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: Dig Health01
Brief Title: Modelling and AI Using Sensor Data to Personalise REHABilitation Following Joint Replacement (MAPREHAB)
Official Title: Digital Health: Modelling and Artificial Intelligence Using Sensor Data to Personalise REHABilitation Following Joint Replacement
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2020
Overall Status: Not yet recruiting
Study Start: June 2020
Primary Completion: January 2021 [Anticipated]
Study Completion: March 2021 [Anticipated]
First Submitted: February 26, 2020
First Submitted that
Met QC Criteria:
February 27, 2020
First Posted: February 28, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
February 27, 2020
Last Update Posted: February 28, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Responsible Party: Sponsor
Collaborators: Dynamic Metrics Ltd
University of East Anglia
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief 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.
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.
Open or close this module Conditions
Conditions: Arthroplasty Complications
Keywords: Arthroplasty
Replacement Rehabilitation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Exercise
Personalised exercise programme is provided to the exercise group.
Exercise
A set of exercises are provided to each patient.
No Intervention: No Intervention
This group of patients will receive no intervention.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Objective change in gait kinematics
[ Time Frame: 15 weeks post op ]

Change in a patient's gait measured objectively using Gaitsmart
2. Subjective change in gait
[ Time Frame: 15 weeks post op ]

Change in a patient's Oxford hip or knee score
3. Quality of life changes
[ Time Frame: 15 weeks post op ]

Change in a patient's Quality of Life score (EQ5D)
Open or close this module Eligibility
Minimum Age: 45 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • All patients who have undergone total hip or knee replacement

Exclusion Criteria:

  • Patients will be excluded if they are currently enrolled on an interventional trial involving surgery, exercise or rehabilitation
  • Patients who have rheumatoid arthritis Patients who are unable to walk Patients who are unable to give their consent
Open or close this module Contacts/Locations
Central Contact Person: Julie Dawson
Telephone: 01603 647882
Email: julie.dawson@nnuh.nhs.uk
Study Officials: Iain McNamara, MD
Principal Investigator
Clinical Research and Trials Unit (Norfolk and Norwich University Hospital, UK)
Locations: United Kingdom, Norfolk
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact:Contact: Julie Dawson 01603 647882 julie.dawson@nnuh.nhs.uk
Open or close this module IPDSharing
Plan to Share IPD: Yes
Anonymised data will be shared by all partners. Only Norfolk and Norwich University Hospital will hold full patient data.
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame:
0 to 28 months, which is 12 months after project completion.
Access Criteria:
Access to the research dataset will be permitted via application to the CI's and sponsor.
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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