- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07622095
Validation of the French Version of the New Mobility Score (NMS) (MOB-SCORE)
Validation of the French Version of the New Mobility Score (NMS) in Hospitalized Patients With Hip Fracture
The incidence of hip fractures in France is 50,000 cases per year among women and 16,000 among men, with a 1-year mortality rate of 20-24%. After a fracture, 10-30% of patients become functionally dependent. The increasing aging of the population and the rise in dependency are likely to worsen the situation of older patients in hospital settings.
Several tools are available to assess functional independence, including the New Mobility Score (NMS), which evaluates mobility through three domains: mobility indoors, mobility outdoors, and shopping activities. The NMS has shown good performance in predicting patient mortality and functional recovery, and its use is recommended in clinical practice. However, the French version of the NMS has not yet been validated.
The French validation of the NMS is important to facilitate its implementation in clinical practice and research, particularly because of its simplicity and the need for rapid assessment tools for healthcare professionals. A French version of the NMS has been translated, and the MOB-SCORE study aims to assess its reliability and validity among healthcare professionals caring for patients with hip fractures.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Olivia FEBVEY-COMBES, MD
- Phone Number: +33 (0)4 72 11 51 62
- Email: olivia.febvey-combes@chu-lyon.fr
Study Locations
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Lyon, France, 69004
- Service I3 de court séjour gériatrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
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Contact:
- Iago HUGHES SANMARTIN, Physiotherapist
- Phone Number: +33 (0)4 26 10 94 75
- Email: Iago.hughes-sanmartin@chu-lyon.fr
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Principal Investigator:
- Iago HUGHES SANMARTIN, Physiotherapist
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 75 years and older admitted to a hospital department following a hip fracture and treated surgically (osteosynthesis or arthroplasty).
- Type of fracture: pertrochanteric fracture or femoral neck fracture.
- Sufficient proficiency in French to complete the questionnaires.
- Patients affiliated with a health insurance scheme.
- No objection to participate from the patient or the caregiver in case of cognitive impairment.
Exclusion Criteria: no exclusion criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Subjects aged 75 years and over admitted to a hospital ward following a hip fracture
Subjects aged 75 years and over, admitted to a hospital service following a hip fracture (per trochanteric or femoral neck) and having received surgical treatment (osteosynthesis or arthroplasty).
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New Mobility Score (NMS), Measure of Functional Independence (MIF), Cumulated Ambulation Score (CAS), Mini-Mental State Examination (MMSE).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inter-rater reliability of the New Mobility Score (NMS)
Time Frame: Within 7 days following the fracture surgery
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The New Mobility Score (NMS) assesses mobility in three domains (indoors, outdoors, and while shopping).
For each domain, a score ranging from 0 (unable to perform the task) to 3 (able to perform the task independently) is assigned, with a total score ranging from 0 to 9. A score of ≤6 indicates functional impairment, whereas a score of >6 indicates a high pre-fracture level of mobility in patients with hip fracture.
The NMS will be rated by a physiotherapist and an adapted physical activity (APA) instructor.
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Within 7 days following the fracture surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Internal consistency of the New Mobility Score (NMS)
Time Frame: Within 7 days following the fracture surgery
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Internal consistency of the New Mobility Score (NMS) items.
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Within 7 days following the fracture surgery
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Convergent validity of the New Mobility Score (NMS) with other functional independence scales, cognitive status and age.
Time Frame: Within 7 days following the fracture surgery
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Correlation between the New Mobility Score (NMS) and:
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Within 7 days following the fracture surgery
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Predictive validity of mortality at postoperative day 30.
Time Frame: Within 30 days following the fracture surgery
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Correlation between the New Mobility Score (NMS) and vital status at postoperative day 30.
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Within 30 days following the fracture surgery
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Discriminatory validity based on place of residence.
Time Frame: Within 7 days following the fracture surgery
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Comparison of the New Mobility Score (NMS) according to pre-fracture living arrangements: living alone versus living in a nursing home/with family.
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Within 7 days following the fracture surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Leg Injuries
- Fractures, Bone
- Femoral Fractures
- Hip Injuries
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Mobility Limitation
- Hip Fractures
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- 69HCL25_0571
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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