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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Arthroplasty Complications Other: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Digital Health: Modelling and Artificial Intelligence Using Sensor Data to Personalise REHABilitation Following Joint Replacement
Actual Study Start Date : September 23, 2020
Actual Primary Completion Date : December 9, 2021
Actual Study Completion Date : February 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.



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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289025


Locations
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United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Sponsors and Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust
Dynamic Metrics Ltd
University of East Anglia
Investigators
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Principal Investigator: Iain McNamara, MD Clinical Research and Trials Unit (Norfolk and Norwich University Hospital, UK)
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Responsible Party: Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04289025    
Other Study ID Numbers: Dig Health01
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
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
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norfolk and Norwich University Hospitals NHS Foundation Trust:
Arthroplasty
Replacement Rehabilitation