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

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ClinicalTrials.gov Identifier: NCT04289025
Recruitment Status : Completed
First Posted : February 28, 2020
Last Update Posted : April 4, 2022
Sponsor:
Collaborators:
Dynamic Metrics Ltd
University of East Anglia
Information provided by (Responsible Party):
Norfolk and Norwich University Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE February 26, 2020
First Posted Date  ICMJE February 28, 2020
Last Update Posted Date April 4, 2022
Actual Study Start Date  ICMJE September 23, 2020
Actual Primary Completion Date December 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
  • Objective change in gait kinematics [ Time Frame: 15 weeks post op ]
    Change in a patient's gait measured objectively using Gaitsmart
  • Subjective change in gait [ Time Frame: 15 weeks post op ]
    Change in a patient's Oxford hip or knee score
  • Quality of life changes [ Time Frame: 15 weeks post op ]
    Change in a patient's Quality of Life score (EQ5D)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modelling and AI Using Sensor Data to Personalise REHABilitation Following Joint Replacement
Official Title  ICMJE Digital Health: Modelling and Artificial Intelligence Using Sensor Data to Personalise REHABilitation Following Joint Replacement
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Arthroplasty Complications
Intervention  ICMJE Other: Exercise
A set of exercises are provided to each patient.
Study Arms  ICMJE
  • Active Comparator: Exercise
    Personalised exercise programme is provided to the exercise group.
    Intervention: Other: Exercise
  • No Intervention: No Intervention
    This group of patients will receive no intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2022)
46
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2020)
100
Actual Study Completion Date  ICMJE February 24, 2022
Actual Primary Completion Date December 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04289025
Other Study ID Numbers  ICMJE Dig Health01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymised data will be shared by all partners. Only Norfolk and Norwich University Hospital will hold full patient data.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Current Responsible Party Norfolk and Norwich University Hospitals NHS Foundation Trust
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Norfolk and Norwich University Hospitals NHS Foundation Trust
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Dynamic Metrics Ltd
  • University of East Anglia
Investigators  ICMJE
Principal Investigator: Iain McNamara, MD Clinical Research and Trials Unit (Norfolk and Norwich University Hospital, UK)
PRS Account Norfolk and Norwich University Hospitals NHS Foundation Trust
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP