Experimentation of a Personalized Physical Self-education Program at Home: Feasibility Study (PROSOL TELEKINECT)

Neuromuscular Diseases Clinical Trial

— TELEKINECT  

Official title:

Experimentation of a Personalized Physical Self-education Program at Home: Feasibility Study (PROSOL TELEKINECT)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05597592
• Other study ID #: 22-PP-13
• Status: Withdrawn
• Phase: N/A
• Start date: February 2023
• Est. completion date: October 2023

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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...)

• 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.

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Neurodegenerative Diseases
• Neuromuscular Diseases

Intervention

Procedure:
• Feasability of a personalised physical rehabilitation program at home
Monitoring of the realization of a personalised physical rehabilitation program at home by patients with neuromuscular and neurodegenrative disease

Locations

Country	Name	City	State
France	Nice CHU	NIce	Provence Alpes Côte d'Azur
Italy	San Martino Hospital	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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).	one week before the program (S1), 2 weeks of the program (S2 and S3) and one week after the end of the program (S4)
Secondary	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	one week before the program (S1) and one week after the end of the program (S4)
Secondary	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.	one week before the program (S1) and one week after the end of the program (S4)
Secondary	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	one week before the program (S1) and one week after the end of the program (S4)
Secondary	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)	one week before the program (S1) and one week after the end of the program (S4)
Secondary	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).	At inclusion visit (V1) and at 4 weeks (V3)
Secondary	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).	At inclusion visit (V1) and at 4 weeks (V3)
Secondary	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".	At inclusion visit (V1), between week 2 and 3 (S2 or S3) and at 4 weeks (V3)
Secondary	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"	During the two weeks of the training programm (S2 and S3)
Secondary	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"	During the two weeks of the training programm (S2 and S3)
Secondary	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.	one week before the program (S1), 2 weeks of the program (S2 and S3) and one week after the end of the program (S4)
Secondary	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.	one week before the program (S1), 2 weeks of the program (S2 and S3) and one week after the end of the program (S4)
Secondary	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"	4 weeks