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

NCT ID: NCT06365177

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2026-12-20

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.

Detailed Description

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.

Tests are realized at baseline after randomization. The test with best time will be considered for analysis.

Once the 2 tests have been carried out, a satisfaction survey will evaluate the preference between the two tests for each patient.

Patients will be re-contacted by telephone at 3, 6 and 12 months post-inclusion to collect the number of falls.

Conditions

Rehabilitation; Elderly Person; Teleconsultation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Physical consultation followed by Teleconsultation

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.

Group Type: OTHER

Physical consultation

Intervention Type: 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.

Teleconsultation

Intervention Type: 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.

Teleconsultation followed by physical consultation

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.

Group Type: OTHER

Physical consultation

Intervention Type: 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.

Teleconsultation

Intervention Type: 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.

Interventions

Physical consultation

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.

Intervention Type: OTHER

Teleconsultation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ILDYS Ty Yann

Brest, , France

Site Status: RECRUITING

Institut de réadaptation du Cap Horn

Landerneau, , France

Site Status: ACTIVE_NOT_RECRUITING

Countries

France

Central Contacts

Vincent CREAC'H

Role: CONTACT

vincent.creach@univ-brest.fr

+33(0)298017935

Facility Contacts

Solène Bourdonneau

Role: primary

solene.bourdonneau@gmail.com

Other Identifiers

29BRC22.0243

Identifier Type: -

Identifier Source: org_study_id