Arthroplasty ComplicationsMAPREHABNCT04289025
Modelling and AI Using Sensor Data to Personalise REHABilitation Following Joint Replacement
A study testing Exercise in people with Arthroplasty Complications, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2020to 24 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subject must provide written informed consent.
- Subject is scheduled for primary Total Knee replacement / Total Hip replacement within the next 30 days.
- Subject is considered skeletally mature.
- Subject is willing, able, and plans to perform the activities associated with the study.
- Unilateral or bilateral hip or knee replacement volunteers free of moderate to severe pain in the contralateral limb.
- Signed off at 6 weeks by physiotherapist.
Who cannot join
- Will not be a resident living within the catchment area for Norfolk \& Norwich University hospital for at least 6 months post-surgery.
- Undertaking the surgery as a private patient.
- Patients who, in the opinion of the clinical staff, do not have capacity to consent.
- Patients who are pregnant.
- Unable to understand written and spoken English.
- Patient who is currently enrolled in another interventional trial involving surgery, exercise or rehabilitation.
- Any neurological condition that affects movement.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthroplasty Complications
- Being tested
- Exercise
- Keywords
- Arthroplasty, Replacement Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
A set of exercises are provided to each patient.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Personalised exercise programme is provided to the exercise group. Receives: Other: Exercise |
| No Intervention | No intervention | This group of patients will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective change in gait kinematics
Change in a patient's gait measured objectively using Gaitsmart
Measured: 15 weeks post op
Subjective change in gait
Change in a patient's Oxford hip or knee score
Measured: 15 weeks post op
Quality of life changes
Change in a patient's Quality of Life score (EQ5D)
Measured: 15 weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start23 Sep 2020
- Primary completion9 Dec 2021
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Dynamic Metrics Ltd, University of East Anglia
- Responsible party
- Sponsor
- Investigators
- Iain McNamara, MD, Principal investigator, Clinical Research and Trials Unit (Norfolk and Norwich University Hospital, UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289025
- Sponsor's protocol ID
- Dig Health01
- Acronym
- MAPREHAB
- Status last verified
- Apr 2022
- First submitted
- 26 Feb 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be shared by all partners. Only Norfolk and Norwich University Hospital will hold full patient data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health: Modelling and Artificial Intelligence Using Sensor Data to Personalise REHABilitation Following Joint Replacement
- ClinicalTrials.gov ID
- NCT04289025
- Acronym / sponsor ID
- MAPREHAB / Dig Health01
- Conditions
- Arthroplasty Complications
- Keywords
- Arthroplasty, Replacement Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Dynamic Metrics Ltd, University of East Anglia
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Other: ExercisePersonalised exercise programme is provided to the exercise group. |
| No Intervention | No intervention | –This group of patients will receive no intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- The subject must provide written informed consent.
- Subject is scheduled for primary Total Knee replacement / Total Hip replacement within the next 30 days.
- Subject is considered skeletally mature.
- Subject is willing, able, and plans to perform the activities associated with the study.
- Unilateral or bilateral hip or knee replacement volunteers free of moderate to severe pain in the contralateral limb.
Key exclusion criteria (7 listed)
- Will not be a resident living within the catchment area for Norfolk \& Norwich University hospital for at least 6 months post-surgery.
- Undertaking the surgery as a private patient.
- Patients who, in the opinion of the clinical staff, do not have capacity to consent.
- Patients who are pregnant.
- Unable to understand written and spoken English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseA set of exercises are provided to each patient. | Other | Exercise |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: Yes. Anonymised data will be shared by all partners. Only Norfolk and Norwich University Hospital will hold full patient data.
Related trials for Arthroplasty Complications
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Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iain McNamara, MD principal investigator
Clinical Research and Trials Unit (Norfolk and Norwich University Hospital, UK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Arthroplasty Complications, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective change in gait kinematics (time frame: 15 weeks post op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.