Neuromuscular DiseasesTELEKINECTNCT05597592
Experimentation of a Personalized Physical Self-education Program at Home: Feasibility Study (PROSOL TELEKINECT)
A study testing Feasability of a personalised physical rehabilitation program at home in people with Neuromuscular Diseases and Neurodegenerative Diseases, run by Centre Hospitalier Universitaire de Nice at 2 sites in 2 countries.
Trial summary
ALCOTRA (Alpes Latines COoperation TRAnsfrontalière) is one of the European cross-border cooperation programmes covering France and Italy and financed by the ERDF (European Regional Development Fund). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Diseases, Neurodegenerative Diseases
- What is being tested?
- Feasability of a personalised physical rehabilitation program at home
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2023to Oct 2023
- 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 higher than 18 years old
- Patient living in the cross-border region concerned by the PROSOL project (Provence Alpes Cote d'Azur, Liguria, Piedmont and Aosta valley)
- Patient with neuropathy with genetic confirmation or myopathy with genetic confirmation or a minor neurocognitive disorder (DSM V criteria) with a Mini Mental State Examination (MMSE) score greater tha or equal to 15 and less than 26
- Patient able to perform the self-rehabilitation program alone or with the help of a caregiver (at the investigator's discretion): ambulant patients alone or with assistance (group 1) or non-ambulant patients able to transfer independently (group 2)
- Likely to be followed by telemedicine (equipped with a smartphone (Apple or Android) and/or a computer, a camera, an internet connection, the smartphone should be compatible with the use of the connected watch (possibility to download mobile applications: Healthmate, Link4life and Telegram
- Patient not planning any change in his lifestyle in the month following the inclusion (hiking, joining a gym, total immobility...)
Show all 9Show fewer
- Patient able to comply with the instructions and procedures specified in the clinical protocol
- Patient has given free and informed consent
- Patient affiliated to a social security system.
Who cannot join
- Patient with balance disorders that are incompatible with the proper conduct of the study based on the investigator's judgment at the inclusion visit
- Patient with any pathologies or comorbidities incompatible with the proper conduct of the study according to the investigator's judgement during the inclusion visit (heart problems, respiratory problems, etc…)
- Patient with pacemaker (this could interfere with data collected by the smartwatch)
- Patient with respiratory problems requiring non-invasive ventilation (NIV) or oxygen therapy
- Patient presenting or having presented in the previous month the inclusion of average physical tiredness (EVA tiredness > 6)
- Patient presenting or having presented in the month before the inclusion of myalgia (EVA pain > 6)
Show all 9Show fewer
- Pregnant or lactating woman or woman of childbearing age without contraception
- Patient protected by law under guardianship or curatorship, or not able to participate in a clinical study under article L. 1121-16 of the French Public Health Code
- Patient refusing to participate in the study or expressing opposition to participation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
ALCOTRA (Alpes Latines COoperation TRAnsfrontalière) is one of the European cross-border cooperation programmes covering France and Italy and financed by the ERDF (European Regional Development Fund). It includes the thematic plan (PITEM), called "PROSOL" (PROximity and SOLidarity), set up in the PIEDMONT region (Italy). The PITEM PROSOL strategy aims to develop new social and health services for vulnerable populations in the rural areas and cross-border Franco-Italian mountains of the South regions (Provence Alpes Cote d'Azur, Liguria, Piedmont and Aosta valley).
As part of the PITEM PROSOL project, a PROSOL telemedicine platform has been developped for the management of isolated patients from the territory of the Latin Alpes and suffering from neurological diseases (neurodevelopmental disorders, neuromuscular diseases and neurodegenerative diseases). These patients are divided into 3 experimental groups: WOMEN (project 5106), SENIORS (project 4128) and YOUTH (project 5162). A PROSOL e-learning platform (https://www.prosol-elearning.com/) has also been developped for these patients, their caregivers and community physicians to improve knowledge and management of these diseases.
Read more
Experimentation of these platforms by several participants (and their caregivers) has highlighted the need, often discontent, of a personalized management of physiotherapy for patients with neuromuscular diseases (MNM) and neurodegenerative diseases (Alzheimer's disease). As physical activity has a beneficial and protective effect of these diseases, and inactivity is one of the important risk factors in worsening symptoms contributing to the loss of patients' motor and cognitive functional abilities, a program of self-physical rehabilitation has been designed by neurologists and physiotherapists of expert centers for a personalized and adapted treatment for each patient.
The PROSOL TELEKINECT project offers a physical rehabilitation program to be carried out autonomously at home, with coaching by physiotherapists via the telemedicine platform, as well as close monitoring of exercise response regarding the level of pain and fatigue of patients, thus ensuring their maximum safety.
The objective of the PROSOL TELEKINECT project is to evaluate the value of an appropriate physical rehabilitation programme for each type of patient. The feasibility and beneficial effects of this program will be assessed using conventional assessments of motor function and patient quality of life, but also using a connected watch coupled with artificial intelligence algorithms to collect and analyze physiological data remotely in real time in the patients' natural environment.
The results of this pilot study will be used to lay the foundation for a larger clinical study to test a new digital strategy for self-treatment rehabilitation, aimed at reducing unequal access to care for patients with neuromuscular and neurodegenerative diseases, and residents of transboundary territories, thus offering the establishment of a preventive and supportive approach to these diseases.
- Conditions
- Neuromuscular Diseases, Neurodegenerative Diseases
- Being tested
- Feasability of a personalised physical rehabilitation program at home
- Medical subject headings
- Neuromuscular Diseases, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasability of a personalised physical rehabilitation program at homeProcedure or surgery
Monitoring of the realization of a personalised physical rehabilitation program at home by patients with neuromuscular and neurodegenrative disease
| Study group | Role | What they receive |
|---|---|---|
| Patients with neuromuscular or neurogenerative disease | Experimental | Not described Receives: Procedure: Feasability of a personalised physical rehabilitation program at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate feasability of a personalized physical rehabilitation program at home
Feasability will be assessed by the number of complete training session performed by each patient. A complete program is composed of 3 sessions per week, during 2 weeks. The program will be considered feasible if at least 80% of patients have completed correctly all the training program.
Measured: 4 weeks
Secondary outcomes (13)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on the daily physical activity at S1, S2, S3 and S4
The daily physical activity will be assessed by the daily distance travelled by ambulant patients. This daily distance will be compared, for each patient, between the week before the program (S1), during the 2 weeks of program (weeks S2 and S3) and the week after the end of the program (S4).
Measured: one week before the program (S1), 2 weeks of the program (S2 and S3) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on the heart rate, one week before the program (S1) and one week after the end of the program (S4)
Heart rate will be collected every day using a connected watch
Measured: one week before the program (S1) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on electrocardiogram (heart cycle), one week before the program (S1) and one week after the end of the program (S4)
Electrocardiogram will be collected every day using a connected watch. Regularity of heart cycle will be analysed.
Measured: one week before the program (S1) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on electrocardiogram (atrial fibrillation), one week before the program (S1) and one week after the end of the program (S4)
Electrocardiogram will be collected every day using a connected watch. Evidence of atrial fibrillation will be analysed
Measured: one week before the program (S1) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on respiratory function, one week before the program (S1) and one week after the end of the program (S4)
Respiratory function will be assessed by the pulse oxugen saturation (SpO2) collected by the connected watch. Value of SpO2 will be compared between one week before the program (S1) and one week after the end of the program (S4)
Measured: one week before the program (S1) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on quality of life for patients with neuromuscular diseases, at V1 and V3
Quality of life of patients with neuromuscular disease will be assessed using the "Individualised Neuromuscular Quality of Life Questionnaire" (INQol, version 2).
Measured: At inclusion visit (V1) and at 4 weeks (V3)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on quality of life for patients with neurodegenerative diseases, at V1 and V3
Quality of life of patients with neuromuscular disease will be assessed using the "The Alzheimer's Disease-Related Quality of Life" (ADRQL).
Measured: At inclusion visit (V1) and at 4 weeks (V3)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on global felt tiredness, before the program at V1, between S2 and S3 and at V3
Global felt tiredness will be assessed using the "Fatigue Severity Scale" (FSS). The FSS is a unidimensional scale which focuses on the physical aspects of fatigue. It is a self-reported questionnaire developed to measure the impact of disabling fatigue on daily functioning. It covers several areas including physical, social, and cognitive effects. The FSS is a patient-reported outcome composed of 9-items with scores ranging from 1 = "strongly disagree" to 7 = "strongly agree".
Measured: At inclusion visit (V1), between week 2 and 3 (S2 or S3) and at 4 weeks (V3)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on felt tiredness, during the program
Tiredness felt during the training programm will be measured with the visual and analog scale for tiredness after each training session, during the two week of the program (S2 and S3).
Score ranges from 0 to 10, 0 being "no tiredness" and 10 being "extrem tiredness"
Measured: During the two weeks of the training programm (S2 and S3)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on pain, during the program
Pain level will be measured with the visual and analog scale for pain after each training session, during the two week of the program (S2 and S3).
Score ranges from 0 to 10, 0 being "no pain" and 10 being "maximum thinkable pain"
Measured: During the two weeks of the training programm (S2 and S3)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on the sleep quality, in particular the duration of sleep, at S1, S2, S3 and S4
The duration of sleep is the total time spent spleeping. This data will be collected by the connected watch.
Measured: one week before the program (S1), 2 weeks of the program (S2 and S3) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on the sleep quality, in particular the intensity of sleep, at S1, S2, S3 and S4
The intensity of sleep is the time spent in restorative phase and in slow sleep. These data will be collected by the connected watch.
Measured: one week before the program (S1), 2 weeks of the program (S2 and S3) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of patients' satisfaction regarding the personalized physical rehabilitation program at home
Satisfaction of the patient will be assessed by a satisfaction questionnaire. Score ranges from 17 to 170, 17 being "not at all satisfied" and 170 being "totally satisfied"
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study startFeb 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: no subcontractors for management of connected watches
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597592
- Sponsor's protocol ID
- 22-PP-13
- Acronym
- TELEKINECT
- Status last verified
- Jan 2023
- First submitted
- 17 Oct 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimentation of a Personalized Physical Self-education Program at Home: Feasibility Study (PROSOL TELEKINECT)
- ClinicalTrials.gov ID
- NCT05597592
- Acronym / sponsor ID
- TELEKINECT / 22-PP-13
- Conditions
- Neuromuscular Diseases, Neurodegenerative Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no subcontractors for management of connected watches
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 28 Oct 2022 (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.
ALCOTRA (Alpes Latines COoperation TRAnsfrontalière) is one of the European cross-border cooperation programmes covering France and Italy and financed by the ERDF (European Regional Development Fund). It includes the thematic plan (PITEM), called "PROSOL" (PROximity and SOLidarity), set up in the PIEDMONT region (Italy). The PITEM PROSOL strategy aims to develop new social and health services for vulnerable populations in the rural areas and cross-border Franco-Italian mountains of the South regions (Provence Alpes Cote d'Azur, Liguria, Piedmont and Aosta valley).
As part of the PITEM PROSOL project, a PROSOL telemedicine platform has been developped for the management of isolated patients from the territory of the Latin Alpes and suffering from neurological diseases (neurodevelopmental disorders, neuromuscular diseases and neurodegenerative diseases). These patients are divided into 3 experimental groups: WOMEN (project 5106), SENIORS (project 4128) and YOUTH (project 5162). A PROSOL e-learning platform (https://www.prosol-elearning.com/) has also been developped for these patients, their caregivers and community physicians to improve knowledge and management of these diseases.
Experimentation of these platforms by several participants (and their caregivers) has highlighted the need, often discontent, of a personalized management of physiotherapy for patients with neuromuscular diseases (MNM) and neurodegenerative diseases (Alzheimer's disease). As physical activity has a beneficial and protective effect of these diseases, and inactivity is one of the important risk factors in worsening symptoms contributing to the loss of patients' motor and cognitive functional abilities, a program of self-physical rehabilitation has been designed by neurologists and physiotherapists of expert centers for a personalized and adapted treatment for each patient.
The PROSOL TELEKINECT project offers a physical rehabilitation program to be carried out autonomously at home, with coaching by physiotherapists via the telemedicine platform, as well as close monitoring of exercise response regarding the level of pain and fatigue of patients, thus ensuring their maximum safety.
The objective of the PROSOL TELEKINECT project is to evaluate the value of an appropriate physical rehabilitation programme for each type of patient. The feasibility and beneficial effects of this program will be assessed using conventional assessments of motor function and patient quality of life, but also using a connected watch coupled with artificial intelligence algorithms to collect and analyze physiological data remotely in real time in the patients' natural environment.
The results of this pilot study will be used to lay the foundation for a larger clinical study to test a new digital strategy for self-treatment rehabilitation, aimed at reducing unequal access to care for patients with neuromuscular and neurodegenerative diseases, and residents of transboundary territories, thus offering the establishment of a preventive and supportive approach to these diseases.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with neuromuscular or neurogenerative disease | Experimental | Procedure: Feasability of a personalised physical rehabilitation program at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age higher than 18 years old
- Patient living in the cross-border region concerned by the PROSOL project (Provence Alpes Cote d'Azur, Liguria, Piedmont and Aosta valley)
- Patient with neuropathy with genetic confirmation or myopathy with genetic confirmation or a minor neurocognitive disorder (DSM V criteria) with a Mini Mental State Examination (MMSE) score greater tha or equal to 15 and less than 26
- Patient able to perform the self-rehabilitation program alone or with the help of a caregiver (at the investigator's discretion): ambulant patients alone or with assistance (group 1) or non-ambulant patients able to transfer independently (group 2)
- Likely to be followed by telemedicine (equipped with a smartphone (Apple or Android) and/or a computer, a camera, an internet connection, the smartphone should be compatible with the use of the connected watch (possibility to download mobile applications: Healthmate, Link4life and Telegram
Key exclusion criteria (9 listed)
- Patient with balance disorders that are incompatible with the proper conduct of the study based on the investigator's judgment at the inclusion visit
- Patient with any pathologies or comorbidities incompatible with the proper conduct of the study according to the investigator's judgement during the inclusion visit (heart problems, respiratory problems, etc…)
- Patient with pacemaker (this could interfere with data collected by the smartwatch)
- Patient with respiratory problems requiring non-invasive ventilation (NIV) or oxygen therapy
- Patient presenting or having presented in the previous month the inclusion of average physical tiredness (EVA tiredness > 6)
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 |
|---|---|---|
| Feasability of a personalised physical rehabilitation program at homeMonitoring of the realization of a personalised physical rehabilitation program at home by patients with neuromuscular and neurodegenrative disease | Procedure or surgery | Patients with neuromuscular or neurogenerative disease |
Primary outcome
Evaluate feasability of a personalized physical rehabilitation program at home
Time frame: 4 weeks
Feasability will be assessed by the number of complete training session performed by each patient. A complete program is composed of 3 sessions per week, during 2 weeks. The program will be considered feasible if at least 80% of patients have completed correctly all the training program.
13 secondary outcomes
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on the daily physical activity at S1, S2, S3 and S4
Time frame: one week before the program (S1), 2 weeks of the program (S2 and S3) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on the heart rate, one week before the program (S1) and one week after the end of the program (S4)
Time frame: one week before the program (S1) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on electrocardiogram (heart cycle), one week before the program (S1) and one week after the end of the program (S4)
Time frame: one week before the program (S1) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on electrocardiogram (atrial fibrillation), one week before the program (S1) and one week after the end of the program (S4)
Time frame: one week before the program (S1) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on respiratory function, one week before the program (S1) and one week after the end of the program (S4)
Time frame: one week before the program (S1) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on quality of life for patients with neuromuscular diseases, at V1 and V3
Time frame: At inclusion visit (V1) and at 4 weeks (V3)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on quality of life for patients with neurodegenerative diseases, at V1 and V3
Time frame: At inclusion visit (V1) and at 4 weeks (V3)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on global felt tiredness, before the program at V1, between S2 and S3 and at V3
Time frame: At inclusion visit (V1), between week 2 and 3 (S2 or S3) and at 4 weeks (V3)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on felt tiredness, during the program
Time frame: During the two weeks of the training programm (S2 and S3)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on pain, during the program
Time frame: During the two weeks of the training programm (S2 and S3)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on the sleep quality, in particular the duration of sleep, at S1, S2, S3 and S4
Time frame: one week before the program (S1), 2 weeks of the program (S2 and S3) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of a personalized physical rehabilitation program at home on the sleep quality, in particular the intensity of sleep, at S1, S2, S3 and S4
Time frame: one week before the program (S1), 2 weeks of the program (S2 and S3) and one week after the end of the program (S4)
Evaluate the feasability of measuring the impact of patients' satisfaction regarding the personalized physical rehabilitation program at home
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feasability of a personalised physical rehabilitation program at home in people with Neuromuscular Diseases and Neurodegenerative Diseases, run by Centre Hospitalier Universitaire de Nice at 2 sites in 2 countries.
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 9 inclusion and 9 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: withdrawn, as of the sponsor's last update on 27 Jul 2023. 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, Italy. 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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluate feasability of a personalized physical rehabilitation program at home (time frame: 4 weeks). 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 27 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.