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Validation of a SOFMER Activity Scale

Validation of a Score Assessing Physical and Cognitive Activities of Patients in Follow-up Care and Rehabilitation Departments: the SOFMER Activity Score

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03116204
Acronym
SAS
Enrollment
152
Registered
2017-04-14
Start date
2018-11-21
Completion date
2021-10-19
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Hospitalized in a FRC Department

Keywords

Dependency, FRC department, scale validation, validity, reliability

Brief summary

A person's dependency is defined as the total or partial inability to perform without helps the necessary activities of daily life due to activity limitations in the usual environment. The consequence is a restriction of participation. In physical and Rehabilitation Medicine (PRM), dependency impacts the healthcare team activity at several levels: patient's referral and care plan, conditions of home return and resumption of course of life, burden of care assessment and care teams management... The main goal of this project is the validation of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation (FRC) departments based on the ICF model (International Classification of Functioning, Disability and Health) : the SOFMER Activity Scale (SAS). We want to propose a French generic scale allowing quantifying precisely the dependence and burden of care of patients in FRC departments. This scale needs to be valid, easy to apply, easy to learn, reproducible, sensitive to change and common to adult subjects, children and elderly.

Interventions

OTHERAssessment of score SAS

Assessment of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation departments

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men and women aged 2 years old * Hospitalized in the participating department for at least 4 days * For the responsiveness study : patients hospitalized in the FRC departments for obesity, spinal cord injuries, post-stroke rehabilitation or cardiorespiratory rehabilitation after cardiac surgery

Exclusion criteria

* Non-recipient of French Social Security

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the validity of SASDay 0The construct validity will be determined by an exploratory factor analysis and confirmed on an independent sample. Criterion validity will be studied by comparison of scores obtained from SAS to scores obtained from references scale (FIM, WeeFIM, ADL, IADL, BREF, BREV, MMSE and items of WISC IV).
Assessment of the reliability of SAS.Day 7For the inter rater reliability study, patients will be rated on the same day by two groups of therapists. For the test-retest reliability study, patients will be rated twice during their hospitalization, within a time frame sufficiently close so that their dependency should not change.

Secondary

MeasureTime frameDescription
Study of SAS responsiveness6 monthsSensitivity to change will be studied on patients hospitalized in a FRC departments for obesity, spinal cord injuries, post-stroke rehabilitation or cardiorespiratory rehabilitation after cardiac surgery. The change between scores of SAS at entry and exit (or at maximum 6 months after inclusion) of hospitalization will be studied.
Study of invariance of SAS: invariance of the classification between age and sex classes.day 0Invariance of SAS will be determined between three age classes (\<18 years, 18-75 years,\> 75 years) using three confirmatory factor analyzes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026