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NCT Number: NCT06365177

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

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.

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Key information

Age range

65 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ILDYS Ty Yann, Brest, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Five Time Sit To Stand test completion time in teleconsultation

    Time frame: At inclusion

    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.

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

    Time frame: At inclusion

    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.

Secondary outcomes

  1. Satisfaction questionnaire

    Time frame: At inclusion

    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
  2. Five Time Sit To Stand test completion time in teleconsultation

    Time frame: At inclusion

    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.

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

    Time frame: At inclusion

    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.

  4. Presence or absence of falls

    Time frame: At Month 3, Month 6 and Month 12

    Phone call to ask if patient has fallen (Yes/No)

  5. Number of falls

    Time frame: At Month 3, Month 6 and Month 12

    Phone calls to ask the number of falls.

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent CREAC'H

CONTACT

[email protected]

+33(0)298017935

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: TELETEST

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Jul 5, 2024

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.

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