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

NCT05597592 | Withdrawn

• 1 other identifier: 22-PP-13
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Neuromuscular Diseases; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (1)

• 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 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

  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)

  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)

  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)

  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)

  one week before the program (S1) and one week after the end of the program (S4)

Study Arms (1)

Patients with neuromuscular or neurogenerative disease

EXPERIMENTAL

Procedure: Feasability of a personalised physical rehabilitation program at home

Interventions

Feasability of a personalised physical rehabilitation program at home PROCEDURE

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

Patients with neuromuscular or neurogenerative disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• Patient with pacemaker (this could interfere with data collected by the smartwatch)
• Patient with respiratory problems requiring non-invasive ventilation (NIV) or oxygen therapy
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

Nice CHU

Nice, Provence-Alpes-Côte d'Azur Region, 06000, France

Location

San Martino Hospital

Genova, 16132, Italy

Location

MeSH Terms

Conditions

Neuromuscular Diseases; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 28, 2022
• Study Start: February 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); IT (1)