Motor DisordersROBOLINK-eNCT04899830
Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients
A study testing Telepresence robot in people with Motor Disorders and Cognitive Disability, run by Association APPROCHE at 4 sites in France.
Trial summary
This study focuses on the mobile robot assist device for tele-interaction: the "COVEALINK 2" robot. This telepresence robot is designed for remote use inside the home. It works with an Internet connection (Wifi or 4G). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motor Disorders, Cognitive Disability
- What is being tested?
- Telepresence robot
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 4 sitesFrance
- Study dates
- 24 Oct 2020to 18 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≧ 18 years old
- Affiliation to a social security scheme or beneficiary of such a scheme
- Having signed a free informed consent in writing
- Hospitalized in PRM for a foreseeable period of at least 60 days
- Living space compatible with the movement of the robot (verified by a home visit by the center's occupational therapist) and equipped with wifi
- Cognitive and motor functions compatible with the use of the tablet or phone independently, with learning capabilities to use the robot and the completion of questionnaires and interviews remotely
- Medically stable
Who cannot join
- Subject being in a period of exclusion from another protocol
- Mood and behavior disorders not stabilized
- Insufficient command of the French language
- Protected adults (guardianship / curatorship)
- Pregnant or breastfeeding women
- Persons deprived of their liberty
- Being unable to issue their consent
- Person who has already presented a form of addiction to technologies and / or video games
Trial locations and contacts
4 sites in 1 country.
France4 sites
CR Mulhouse
Mulhouse, Alsace, 68100
CMRRF de Kerpape
Ploemeur, Brittany Region, 56270
CMPR Côte d'Amour
Saint-Nazaire, Pays de la Loire Region, 44600
IUR Clémenceau
Strasbourg, Alsace, 67000
About this study
This study focuses on the mobile robot assist device for tele-interaction: the "COVEALINK 2" robot. This telepresence robot is designed for remote use inside the home. It works with an Internet connection (Wifi or 4G). It consists of a control interface (an application installed on the smartphone or tablet of the hospitalized patient) and a mobile robot placed in the home of the hospitalized patient (composed of a mobile platform, a visualization screen whose tilt is adjustable remotely for better adaptation to the interlocutors and an audio communication system). From the app installed on his smartphone or tablet, the patient hospitalized in the center for a long time (2 months minimum) will be able to start remotely (from the center where he is hospitalized) the robot and have it move within his home to communicate with the people present at the time of use (family, friends, neighbors etc.).
- Conditions
- Motor Disorders, Cognitive Disability
- Being tested
- Telepresence robot
- Medical subject headings
- Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telepresence robotDevice
From the application installed on a tablet, the patient hospitalized in a center for a period of at least 2 months can start from the center where he is hospitalized the mobile robotic telepresence assistance device installed at home to communicate with his family, his friends, his neighbors,…)
| Study group | Role | What they receive |
|---|---|---|
| Installation of a telepresence robot in the home of a disabled person hospitalized in a PRM center | Experimental | From the application installed on a tablet, the patient hospitalized in a center for a period of at least 2 months can start from the center where he is hospitalized the mobile robotic telepresence assistance device installed at home to communicate with his family, his friends, his neighbors,…) Receives: Device: Telepresence robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the medium-term acceptance of robotic tele-interaction
Measured with hospitalized patients using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication)
Measured: At 2 months
Secondary outcomes (12)
Evaluation of the a priori acceptability of robotic tele-interaction
Measured with hospitalized patients using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication). Measure of the a priori acceptability on Day 0. A priori acceptability corresponds to the study of representations of the user upstream of any use of the technology.
Measured: Day 0
Evaluation of the short-term acceptance of robotic tele-interaction
Measured with hospitalized patients using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication). Measurement of acceptance at Day 30. The acceptance phase studies the user's judgment and impressions after the user's first interactions with the system
Measured: At 1 month
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
This assessment is done using validated measurement scale relating to depression and anxiety: HAD scale (Hospital Anxiety and Depression). The HAD scale is an instrument used to screen for anxiety and depressive disorders. It comprises 14 items graded from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21 ).To screen for anxiety and depressive symptoms, the following interpretation is used for each of the scores (A and D): - 7 or less: no symptoms - 8 to 10: doubtful symptomatology - 11 and over: definite symptomatology.
Measured: Day 0
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
This assessment is done using validated measurement scale relating to psychological well-being: EBEP (Psychological Well-Being Scale). The Ryff scale of psychological well-being "is constructed from six key dimensions: autonomy, mastery of the environment, personal development, positive relationships, giving meaning to one's life and acceptance of life. self. It consists of 18 items sides 1 to 6, where 6 indicating strongly agree. A high total score indicates psychological well-being.
Measured: Day 0
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
This assessment is done using validated measurement scale relating to quality of life: questionnaire general SF-36 (Short Form 36 Healt Survey). The SF-36 questionnaire is a multidimensional questionnaire that assesses quality of life in relation to health status, regardless of causal pathology, gender, age and treatment. It assesses functioning and overall well-being using a questionnaire using 36 questions divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality, functioning or social well-being, role limitations related to mental health, mental health).
Measured: Day 0
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
This assessment is done using validated measurement scale relating to level of social participation: LHS scale (London Handicap Scale). This scale questions everyday life by assessing mobility, physical independence, occupation (work, hobbies, vacations, etc.), social integration, perception of the outside world and economic independence.
It takes the form of a questionnaire comprising 6 items rated from 0 to 1: - 1 = no handicap - 0 = maximum handicap.
Measured: Day 0
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
This assessment is done using validated measurement scale relating to depression and anxiety: HAD scale (Hospital Anxiety and Depression). The HAD scale is an instrument used to screen for anxiety and depressive disorders. It comprises 14 items graded from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21 ).To screen for anxiety and depressive symptoms, the following interpretation is used for each of the scores (A and D): - 7 or less: no symptoms - 8 to 10: doubtful symptomatology - 11 and over: definite symptomatology.
Measured: At 2 months
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
This assessment is done using validated measurement scale relating to psychological well-being: EBEP (Psychological Well-Being Scale). The Ryff scale of psychological well-being "is constructed from six key dimensions: autonomy, mastery of the environment, personal development, positive relationships, giving meaning to one's life and acceptance of life. self. It consists of 18 items sides 1 to 6, where 6 indicating strongly agree. A high total score indicates psychological well-being.
Measured: At 2 months
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
This assessment is done using validated measurement scale relating to quality of life: questionnaire general SF-36 (Short Form 36 Healt Survey). The SF-36 questionnaire is a multidimensional questionnaire that assesses quality of life in relation to health status, regardless of causal pathology, gender, age and treatment. It assesses functioning and overall well-being using a questionnaire using 36 questions divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality, functioning or social well-being, role limitations related to mental health, mental health).
Measured: At 2 months
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
This assessment is done using validated measurement scale relating to level of social participation: LHS scale (London Handicap Scale). This scale questions everyday life by assessing mobility, physical independence, occupation (work, hobbies, vacations, etc.), social integration, perception of the outside world and economic independence.
It takes the form of a questionnaire comprising 6 items rated from 0 to 1: - 1 = no handicap - 0 = maximum handicap.
Measured: At 2 months
Evaluation of the a priori acceptability of robotic tele-interaction for users, relatives and members of the multidisciplinary team
Measurement with categories of users around the patient and members of the multidisciplinary team, using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication). Measurement of a priori acceptability on Day 0. A priori acceptability corresponds to the study of representations of the user upstream of any use of the technology.
Measured: Day 0
Evaluation of the medium-term acceptance of robotic tele-interaction for users, relatives and members of the multidisciplinary team
Measurement with categories of users around the patient and members of the multidisciplinary team, using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication). Measurement of acceptance at Day 60. The acceptance phase studies the user's judgment and impressions after the user's first interactions with the system.
Measured: At 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start24 Oct 2020
- Primary completion18 Jan 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DisordersStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association APPROCHE
- Sponsor type
- University, hospital or other
- Collaborators
- COVEA, University of Rennes 2
- Responsible party
- Sponsor
- Investigators
- Thibaud Honoré, Doctor, Principal investigator, CMRRF de Kerpape
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899830
- Sponsor's protocol ID
- 2019-A02088-49
- Acronym
- ROBOLINK-e
- Status last verified
- Feb 2020
- First submitted
- 10 May 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients
- ClinicalTrials.gov ID
- NCT04899830
- Acronym / sponsor ID
- ROBOLINK-e / 2019-A02088-49
- Conditions
- Motor Disorders, Cognitive Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Association APPROCHEUniversity, hospital or other
- Collaborators
- COVEA, University of Rennes 2
- Study start
- 24 Oct 2020 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 25 May 2021 (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 focuses on the mobile robot assist device for tele-interaction: the "COVEALINK 2" robot. This telepresence robot is designed for remote use inside the home. It works with an Internet connection (Wifi or 4G). It consists of a control interface (an application installed on the smartphone or tablet of the hospitalized patient) and a mobile robot placed in the home of the hospitalized patient (composed of a mobile platform, a visualization screen whose tilt is adjustable remotely for better adaptation to the interlocutors and an audio communication system). From the app installed on his smartphone or tablet, the patient hospitalized in the center for a long time (2 months minimum) will be able to start remotely (from the center where he is hospitalized) the robot and have it move within his home to communicate with the people present at the time of use (family, friends, neighbors etc.).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Installation of a telepresence robot in the home of a disabled person hospitalized in a PRM center | Experimental | Device: Telepresence robotFrom the application installed on a tablet, the patient hospitalized in a center for a period of at least 2 months can start from the center where he is hospitalized the mobile robotic telepresence assistance device installed at home to communicate with his family, his friends, his neighbors,…) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≧ 18 years old
- Affiliation to a social security scheme or beneficiary of such a scheme
- Having signed a free informed consent in writing
- Hospitalized in PRM for a foreseeable period of at least 60 days
- Living space compatible with the movement of the robot (verified by a home visit by the center's occupational therapist) and equipped with wifi
Key exclusion criteria (8 listed)
- Subject being in a period of exclusion from another protocol
- Mood and behavior disorders not stabilized
- Insufficient command of the French language
- Protected adults (guardianship / curatorship)
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Telepresence robotFrom the application installed on a tablet, the patient hospitalized in a center for a period of at least 2 months can start from the center where he is hospitalized the mobile robotic telepresence assistance device installed at home to communicate with his family, his friends, his neighbors,…) | Device | Installation of a telepresence robot in the home of a disabled person hospitalized in a PRM center |
Primary outcome
Evaluation of the medium-term acceptance of robotic tele-interaction
Time frame: At 2 months
Measured with hospitalized patients using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication)
12 secondary outcomes
Evaluation of the a priori acceptability of robotic tele-interaction
Time frame: Day 0
Evaluation of the short-term acceptance of robotic tele-interaction
Time frame: At 1 month
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Time frame: Day 0
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Time frame: Day 0
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Time frame: Day 0
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Time frame: Day 0
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Time frame: At 2 months
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Time frame: At 2 months
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Time frame: At 2 months
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Time frame: At 2 months
Evaluation of the a priori acceptability of robotic tele-interaction for users, relatives and members of the multidisciplinary team
Time frame: Day 0
Evaluation of the medium-term acceptance of robotic tele-interaction for users, relatives and members of the multidisciplinary team
Time frame: At 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Thibaud Honoré, Doctor principal investigator
CMRRF de Kerpape
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telepresence robot in people with Motor Disorders and Cognitive Disability, run by Association APPROCHE at 4 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the medium-term acceptance of robotic tele-interaction (time frame: At 2 months). 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 6 Mar 2026.