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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06365177
Other study ID # 29BRC22.0243
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date May 1, 2026

Study information

Verified date April 2024
Source University Hospital, Brest
Contact Vincent CREAC'H
Phone +33(0)298017935
Email vincent.creach@univ-brest.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 108
Est. completion date May 1, 2026
Est. primary completion date May 1, 2026
Accepts healthy volunteers No
Gender All
Age group 65 Years to 110 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Satisfaction questionnaire It is a questionnaire with 4 questions:
Question n°1 : 3 answers Question n°2 : bimodal response (Yes /No) Question n°3 : 5 answers Question n°4 : 4 answers
Moreover, the therapist completes the following question for each patient:
- Do you think this patient could benefit from a follow-up by performing the same test in teleconsultation at home? Yes/No
At inclusion
Secondary 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
Secondary 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 Presence or absence of falls Phone call to ask if patient has fallen (Yes/No) At Month 3, Month 6 and Month 12
Secondary Number of falls Phone calls to ask the number of falls. At Month 3, Month 6 and Month 12
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