RehabilitationTELETESTNCT06365177
Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation
A study testing Physical consultation and Teleconsultation in people with Rehabilitation and Elderly Person, run by University Hospital, Brest at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Rehabilitation, Elderly Person, Teleconsultation
- What is being tested?
- Physical consultation and Teleconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Jun 2024to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 1 recruiting
- Recruiting
ILDYS Ty Yann
Brest, 29200
Solène Bourdonneau, solene.bourdonneau@gmail.com
- Active, not recruiting
Institut de réadaptation du Cap Horn
Landerneau, 29800
About this study
Official title: Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation of the Elderly
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.
Read the 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
- Being tested
- Physical consultation, Teleconsultation
- Keywords
- Five Time Sit To Stand, Teleconsultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical consultationOther
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.
TeleconsultationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physical consultation; Other: Teleconsultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At inclusion
Secondary outcomes (5)
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
Measured: At inclusion
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.
Measured: 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.
Measured: At inclusion
Presence or absence of falls
Phone call to ask if patient has fallen (Yes/No)
Measured: At Month 3, Month 6 and Month 12
Number of falls
Phone calls to ask the number of falls.
Measured: At Month 3, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start20 Jun 2024
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-sectional interventional multicenter study
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365177
- Sponsor's protocol ID
- 29BRC22.0243
- Acronym
- TELETEST
- Status last verified
- Jul 2024
- First submitted
- 10 Apr 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation of the Elderly
- ClinicalTrials.gov ID
- NCT06365177
- Acronym / sponsor ID
- TELETEST / 29BRC22.0243
- Conditions
- Rehabilitation, Elderly Person, Teleconsultation
- Keywords
- Five Time Sit To Stand, Teleconsultation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-sectional interventional multicenter study
| Arm | Type | Receives |
|---|---|---|
| Physical consultation followed by Teleconsultation | Other | Other: Physical consultation, Other: TeleconsultationFirst, 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. |
| Teleconsultation followed by physical consultation | Other | Other: Physical consultation, Other: TeleconsultationFirst, 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. |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical consultationThe 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. | Other | Physical consultation followed by Teleconsultation, Teleconsultation followed by physical consultation |
| TeleconsultationPrior 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. | Other | Physical consultation followed by Teleconsultation, Teleconsultation followed by physical consultation |
Primary outcome
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.
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.
5 secondary outcomes
Satisfaction questionnaire
Time frame: At inclusion
Five Time Sit To Stand test completion time in teleconsultation
Time frame: At inclusion
Five Time Sit To Stand test completion time in face-to-face consultation
Time frame: At inclusion
Presence or absence of falls
Time frame: At Month 3, Month 6 and Month 12
Number of falls
Time frame: At Month 3, Month 6 and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical consultation and Teleconsultation in people with Rehabilitation and Elderly Person, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent CREAC'H (+33(0)298017935, vincent.creach@univ-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five Time Sit To Stand test completion time in teleconsultation (time frame: At inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.