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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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 i

Первичные конечные точки

• Five Time Sit To Stand test completion time in teleconsultation [Срок оценки: At inclusion]
• Five Time Sit To Stand test completion time in face-to-face consultation [Срок оценки: At inclusion]

Вторичные конечные точки (5)

• Satisfaction questionnaire [Срок оценки: At inclusion]
• Five Time Sit To Stand test completion time in teleconsultation [Срок оценки: At inclusion]
• Five Time Sit To Stand test completion time in face-to-face consultation [Срок оценки: At inclusion]
• Presence or absence of falls [Срок оценки: At Month 3, Month 6 and Month 12]
• Number of falls [Срок оценки: At Month 3, Month 6 and Month 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 2 центра

• ILDYS Ty Yann — Brest
• Institut de réadaptation du Cap Horn — Landerneau

Идентификаторы

NCT: NCT06365177 · 29BRC22.0243

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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