Validation of a SOFMER Activity Scale (SAS)

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

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.

Study Overview

• Status: Completed
• Conditions: Patients Hospitalized in a FRC Department
• Intervention / Treatment: Other: Assessment of score SAS

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Centre SSR Les Capucins
  • Berck, France
    • Etablissement Hopale-Centre Calvé
  • Brest, France
    • Service SSRS Enfants et Adolescents, Fondation Ildys
  • Garche, France
    • Médecine physique et réadaptation - Hôpital Raymond Poincaré - APHP
  • Lyon, France
    • Ctre Médico-Chir Réadapt Des Massues
  • Lyon, France
    • Service de Médecine physique et Réadaptation - Hôpital Henry Gabrielle
  • Paris, France
    • Service de Médecine Physique et de Réadaptation - F.Widal - APHP
  • Saint-Etienne, France
    • Service de Médecine Physique et Réadaptation - Pôle Couple Mère-Enfant - HOPITAL DE BELLEVUE
  • Échirolles, France
    • Département de Rééducation Neurologique - Hôpital Sud - CHU de Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in a FRC department

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients hospitalized in a FRC department	Other: Assessment of score SAS; Assessment of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation departments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the validity of SAS	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).	Day 0
Assessment of the reliability of SAS.	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.	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study of SAS responsiveness	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.	6 months
Study of invariance of SAS: invariance of the classification between age and sex classes.	Invariance of SAS will be determined between three age classes (<18 years, 18-75 years,> 75 years) using three confirmatory factor analyzes	day 0

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Carole VUILLEROT, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Actual): October 19, 2021
• Study Completion (Actual): October 19, 2021

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: validity; reliability; Dependency; FRC department; scale validation
• Other Study ID Numbers: 69HCL17_0027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No