Clinical Validation of a Mobility Monitor to Measure and Predict Health Outcomes

NCT04911231 | Completed DMC

• 1 other identifier: RECHMPL20_0700
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (2)

• 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

  24 months

• Admission to a care home

  Assessed from patient records at 6 months follow-up

  6 months

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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),
• Subject having had a cardiac resynchronization therapy device implanted (CRTD),
• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator

Study Sites (2)

Polyclinique Saint-Roch

Montpellier, 34000, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Hubert Blain, PD PH

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: June 2, 2021
• Study Start: October 4, 2021
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

FR (2)