Completed

NCT Number: NCT03116204

Validation of a SOFMER Activity Scale

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.

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Key information

Conditions

Patients Hospitalized in a FRC Department

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre SSR Les Capucins, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of score SAS

Other

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

Primary outcomes

Assessment of the validity of SAS

Time frame: Day 0

The 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.

Time frame: Day 7

For 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 outcomes

Study of SAS responsiveness

Time frame: 6 months

Sensitivity 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.

Time frame: day 0

Invariance of SAS will be determined between three age classes (<18 years, 18-75 years,> 75 years) using three confirmatory factor analyzes

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: SAS

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Apr 14, 2017
Registry last updated: Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.