Hip FracturesMOBILISE-DNCT04911231
Clinical Validation of a Mobility Monitor to Measure and Predict Health Outcomes
An observational study of Hip Fractures, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
Background and study aims The ability to move is important for general well-being. Ageing and chronic health conditions can lead to a loss of mobility and a loss of independence. In order to treat mobility loss, tools are needed that can detect and accurately measure mobility. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hip Fractures
- How many people
- 62 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Oct 2021to 4 Mar 2024
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will recruit two groups, both acute (during hospital stay after hip fracture) and subacute (up to 6 months post hip fracture from waiting lists). With this strategy the investigators will not only have one segment of the disease, but the life-course of PFF (first 12 months and the time after). Acute phase inclusion is defined as inclusion start on first days after surgery and will be completed within the first 14 days. Subacute phase inclusion is defined as inclusion from waiting lists, where baseline will be conducted up to 6 months after hip fracture surgery.
Who may be able to join
- Aged 45 or over
- Surgical treatment (fixation or arthroplasty) for a low-energy fracture of the proximal femur (ICD-10 diagnosis S72.0, S72.1, S72.2) as diagnosed on X-rays of the hip and pelvis. Between 3 days and 52 weeks post-surgery
- be able to walk 4 meters
- -.be available for 24 months following the fracture,
- be able to read and understand the briefing note and complete questionnaires feedback
- express their will and sign a consent to participate in follow-up testing, and to wear the motion sensor
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- Occurrence of one of the following events in the 3 months preceding the consent enlightened
- subject with a history of myocardial infarction,
- Subject hospitalized for unstable angina,
- Subject with a history of stroke,
- Subject with a history of coronary bypass surgery (PAC),
- Subject having had percutaneous coronary intervention (PCI),
Show all 15Show fewer
- Subject having had a cardiac resynchronization therapy device implanted (CRTD),
- Other criteria for non-inclusions
- Subject with active treatment for cancer or other malignant disease,
- Subject with uncontrolled congestive heart disease (NYHA class> 3),
- Subject with acute psychosis or major psychiatric disorders
- Subject with continued drug addiction.
- Subject unable to walk prior to hip fracture treatment.
- The patient is participating in another interventional category I study,
- l All categories of persons particularly protected under the law French (adults under guardianship, guardianship or safeguard of justice…. articles L1121-8 - L1121-5 - L1121-6 - L1121-7 - L1121-9 of the Health Code Public)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Polyclinique Saint-Roch
Montpellier, 34000
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
About this study
Official title: Validating Digital Mobility Assessment Using Wearable Technology - the Mobilide-D Clinical Validation Study
Background and study aims The ability to move is important for general well-being. Ageing and chronic health conditions can lead to a loss of mobility and a loss of independence. In order to treat mobility loss, tools are needed that can detect and accurately measure mobility. Existing measures of mobility (based on self-reporting and one-off tests) are highly limited. Wearable digital technology (a small device worn on the body) that can be used in the home and the community can provide a simple, accurate and low-cost measure of mobility. The researchers have validated a wearable mobility monitor which can accurately measure how well a person walks by measuring aspects of mobility such as speed and symmetry. The aim of this study is to investigate the ability of the mobility monitor to measure and predict outcomes in proximal femoral fracture (PFF) patients. The digital assessment of mobility developed in this study will be used in clinical trials and in clinical practice.
Read the detailed description
The study plans to include patients in two groups, both acute (during hospital stay after hip fracture) and subacute (up to 6 months post hip fracture from waiting lists). With this strategy, it is possible to have the life-course of PFF (first 12 months and the time after). Acute phase inclusion is defined as inclusion start on first days after surgery and will be completed within the first 14 days. Subacute phase inclusion is defined as inclusion from waiting lists, where baseline will be conducted up to 6 months after hip fracture surgery.
Fear of falling will be tested using a single question during the acute phase and the short form of the fall efficacy scale international (Short FES-I) for all other assessments. For the acute recruited group of patients (2/3 of included participants), sensor recordings will be made on patients from hospital stay (attached on day 2 after surgery) and continue after discharge (until day 9 depending on battery capacity of the sensors) to be able to monitor and describe DMOs from about 2 days during hospital stay and several days after discharge to be able to evaluate improvement during the acute rehabilitation process. For all other assessments, sensor recordings will be collected for a minimum of 7 full continuous days in line with the core data collection manual.
Hip fracture patients will be tested for sarcopenia according to the updated definitions of the European and US-American working groups. In centers where bioimpedance measurements are possible, participants will receive this measurement as part of the core data collection.
- Conditions
- Hip Fractures
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the functional component score of the Late-Life Functional Disability Index (LLFDI), that goes from 0 to 100, during 24 months follow-up.
Measured at baseline, 6, 12, 18 and 24 months
Measured: 24 months
Admission to a care home
Assessed from patient records at 6 months follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start4 Oct 2021
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Hubert Blain, PD PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911231
- Sponsor's protocol ID
- RECHMPL20_0700
- Acronym
- MOBILISE-D
- Status last verified
- Aug 2024
- First submitted
- 6 May 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating Digital Mobility Assessment Using Wearable Technology - the Mobilide-D Clinical Validation Study
- ClinicalTrials.gov ID
- NCT04911231
- Acronym / sponsor ID
- MOBILISE-D / RECHMPL20_0700
- Conditions
- Hip Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 2 Jun 2021 (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.
Background and study aims The ability to move is important for general well-being. Ageing and chronic health conditions can lead to a loss of mobility and a loss of independence. In order to treat mobility loss, tools are needed that can detect and accurately measure mobility. Existing measures of mobility (based on self-reporting and one-off tests) are highly limited. Wearable digital technology (a small device worn on the body) that can be used in the home and the community can provide a simple, accurate and low-cost measure of mobility. The researchers have validated a wearable mobility monitor which can accurately measure how well a person walks by measuring aspects of mobility such as speed and symmetry. The aim of this study is to investigate the ability of the mobility monitor to measure and predict outcomes in proximal femoral fracture (PFF) patients. The digital assessment of mobility developed in this study will be used in clinical trials and in clinical practice.
Detailed description
The study plans to include patients in two groups, both acute (during hospital stay after hip fracture) and subacute (up to 6 months post hip fracture from waiting lists). With this strategy, it is possible to have the life-course of PFF (first 12 months and the time after). Acute phase inclusion is defined as inclusion start on first days after surgery and will be completed within the first 14 days. Subacute phase inclusion is defined as inclusion from waiting lists, where baseline will be conducted up to 6 months after hip fracture surgery.
Fear of falling will be tested using a single question during the acute phase and the short form of the fall efficacy scale international (Short FES-I) for all other assessments. For the acute recruited group of patients (2/3 of included participants), sensor recordings will be made on patients from hospital stay (attached on day 2 after surgery) and continue after discharge (until day 9 depending on battery capacity of the sensors) to be able to monitor and describe DMOs from about 2 days during hospital stay and several days after discharge to be able to evaluate improvement during the acute rehabilitation process. For all other assessments, sensor recordings will be collected for a minimum of 7 full continuous days in line with the core data collection manual.
Hip fracture patients will be tested for sarcopenia according to the updated definitions of the European and US-American working groups. In centers where bioimpedance measurements are possible, participants will receive this measurement as part of the core data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will recruit two groups, both acute (during hospital stay after hip fracture) and subacute (up to 6 months post hip fracture from waiting lists). With this strategy the investigators will not only have one segment of the disease, but the life-course of PFF (first 12 months and the time after). Acute phase inclusion is defined as inclusion start on first days after surgery and will be completed within the first 14 days. Subacute phase inclusion is defined as inclusion from waiting lists, where baseline will be conducted up to 6 months after hip fracture surgery.
Key inclusion criteria (7 listed)
- Aged 45 or over
- Surgical treatment (fixation or arthroplasty) for a low-energy fracture of the proximal femur (ICD-10 diagnosis S72.0, S72.1, S72.2) as diagnosed on X-rays of the hip and pelvis. Between 3 days and 52 weeks post-surgery
- be able to walk 4 meters
- -.be available for 24 months following the fracture,
- be able to read and understand the briefing note and complete questionnaires feedback
Key exclusion criteria (15 listed)
- Occurrence of one of the following events in the 3 months preceding the consent enlightened
- subject with a history of myocardial infarction,
- Subject hospitalized for unstable angina,
- Subject with a history of stroke,
- Subject with a history of coronary bypass surgery (PAC),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the functional component score of the Late-Life Functional Disability Index (LLFDI), that goes from 0 to 100, during 24 months follow-up.
Time frame: 24 months
Measured at baseline, 6, 12, 18 and 24 months
Admission to a care home
Time frame: 6 months
Assessed from patient records at 6 months follow-up
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 15 Aug 2024.
Related trials for Hip Fractures
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
Hubert Blain, PD PH principal investigator
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by University Hospital, Montpellier at 2 sites in France.
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 7 inclusion and 15 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 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Change in the functional component score of the Late-Life Functional Disability Index (LLFDI), that goes from 0 to 100, during 24 months follow-up. (time frame: 24 months). The study lists 2 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 15 Aug 2024.