Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation

NCT06365177 | Recruiting

• 1 other identifier: 29BRC22.0243
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

This study concerns elderly person aged more than 65 years with autonomous mobility. It is a multicentric randomized trial in two arms : Arm one : remote consultation then physical consultation Arm two : physical consultation then remote consultation Consultations consist to take a Five Times Sit To Stand test, in physical consultation with physiotherapist in the same room and in remote consultation with a physiotherapist in the next room to the patient.

Conditions

Rehabilitation; Elderly Person; Teleconsultation

Keywords

Five Time Sit To Stand; Teleconsultation

Outcome Measures

Primary Outcomes (2)

• Five Time Sit To Stand test completion time in teleconsultation

  The physiotherapist is present in a room at a distance from the patient's consultation room. The Five Time Sit to Stand (FTSS) is a functional assessment that requires a chair and a stopwatch. The patient is timed from start to finish. The time taken to complete the test is expressed in minutes. The patient performs two trials. The best result is retained for analysis.

  At inclusion

• Five Time Sit To Stand test completion time in face-to-face consultation

  The physiotherapist is present in the same consulting room as the patient. The Five Time Sit to Stand (FTSS) is a functional assessment that requires a chair and a stopwatch. The patient is timed from start to finish. The time taken to complete the test is expressed in minutes. The patient performs two trials. The best result is retained for analysis.

  At inclusion

Secondary Outcomes (5)

• Satisfaction questionnaire

  At inclusion

• Five Time Sit To Stand test completion time in teleconsultation

  At inclusion

• Five Time Sit To Stand test completion time in face-to-face consultation

  At inclusion

• Presence or absence of falls

  At Month 3, Month 6 and Month 12

• Number of falls

  At Month 3, Month 6 and Month 12

Study Arms (2)

Physical consultation followed by Teleconsultation

OTHER

First, patients take the Five Time Sit To Stand in the presence of the physiotherapist. Then, patients perform the test in a room away from the physiotherapist (there are a computer with a webcam is set up on a desk). There will be a 5-minute rest period between the 2 test conditions (physical consultation and teleconsultation). Each test is performed 2 times. The best time will be retained for analysis.

Other: Physical consultation; Other: Teleconsultation

Teleconsultation followed by physical consultation

OTHER

First, patients perform the Five Time Sit To Stand in a room away from the physiotherapist (there are a computer with a webcam is set up on a desk). Then, patients take the test in the presence of the physiotherapist. There will be a 5-minute rest period between the 2 test conditions (teleconsultation and physical consultation). Each test is performed 2 times. The best time will be retained for analysis.

Other: Physical consultation; Other: Teleconsultation

Interventions

Physical consultation OTHER

The subject enters a room where the therapist is present. A chair is placed against a wall in the same room. Once again, the therapist suggests repeating the test. During the test, the therapist sits opposite the patient, at the same distance as the computer used during the teleconsultation.

Physical consultation followed by Teleconsultation; Teleconsultation followed by physical consultation

Teleconsultation OTHER

Prior to the test, the investigator should carry out a "mock" test with a volunteer from the facility, for example, to ensure wifi, sound and image functionality. The patient enters a room where a computer equipped with a webcam is set up on a desk. The teleconsultation has already started when the patient enters the room. No recordings are made. A chair is placed at a distance from the desk, with the backrest against a wall. The chair faces the computer. The desk or table where the computer is located is about 3 meters from the participant, ensuring that the webcam can frame the patient's entire body during the test. With the consultation already underway, the investigator can direct the patient to sit in the chair against the wall. The investigator will make sure that the patient hears the instructions given. Once the patient is seated on the chair, the therapist explains the test procedure and shows it once to make sure the subject understands it.

Physical consultation followed by Teleconsultation; Teleconsultation followed by physical consultation

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Volunteers over the age of 65.
• Elderly people who can walk and move around independently.
• Subjects capable of giving informed consent.
• GIR 3,4,5,6.
• Affiliated to a Social Security scheme.

You may not qualify if:

• GIR \< 3
• Major visual and/or hearing impairment (known pathology and not fitted with hearing aids)
• Patient deprived of liberty by judicial or administrative decision, under guardianship or curatorship
• Subject having refused to participate.
• Subject at risk of syncope on rising (cardiac pathologies, orthostatic hypotension).
• Subjects with known vestibular disorders.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

ILDYS Ty Yann

Brest, 29200, France

RECRUITING

Institut de réadaptation du Cap Horn

Landerneau, 29800, France

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Remote Consultation

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management

Central Study Contacts

Vincent CREAC'H

CONTACT

+33(0)298017935; vincent.creach@univ-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional interventional multicenter study

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient.
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.

Locations

FR (2)