Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 2:42 PM
Study NCT ID:
NCT06378203
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation in Muscular Dystrophies From the Hospital Facility to the Home: Pilot Project [RIMUDI]
Sponsor:
IRCCS Eugenio Medea
Organization:
Study Overview
Official Title:
Rehabilitation in Muscular Dystrophies From the Hospital Facility to the Home: Pilot Project
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIMUDI
Brief Summary:
Until twenty years ago physical exercise in muscular dystrophies was considered harmful to the muscle cells, inducing an acceleration of cell necrosis. In fact, it is now certain and validated that an active lifestyle and the practice of controlled and regular physical activity are to be considered therapeutic in neuromuscular pathologies with the aim of optimizing muscular and cardio-respiratory function and preventing atrophy In particular, it seems that the optimal care is extensive and can be carried out in a safe and controlled manner even at home.
It is well documented that exercise has beneficial effects on muscle with increased strength and muscular endurance.
It is well documented that exercise has beneficial effects on muscle with increased strength and muscular endurance.
Detailed Description:
This project was born precisely from the idea of giving an answer to the needs of patients on the one hand regarding being educated to carry out a physical activity/exercise "suitable" for the dystrophic muscle fiber and on the other to be able to insert this into everyday life activities, with remote expert monitoring.
One aim is to offer continuity of care between the hospital structure and the home, also offering a concrete response to the inconsistent care guaranteed for these chronic developmental diseases by the National Health Service. The drafting of a personalized therapeutic plan, to be implemented within the home, would not only support the patient's motor needs, but would also guarantee a positive impact on a psychological level, strengthening the patient's participation in shared therapeutic objectives and awareness of the same. This pilot project aims to evaluate the effectiveness of a 6-month tele-rehabilitation program for continuity of care in a population of subjects suffering from neuromuscular pathology. The primary outcome will then be integrated with an assessment of tolerance of the path and usability and acceptability of the tele-rehabilitation system used.
Each patient will carry out a series of evaluation and training sessions (15 sessions) with a physiotherapist for the drafting of a personalized treatment plan that subsequently will be carried out "independently" at domicile.
During these days, periodic clinical-instrumental evaluations indicated by the specific guidelines for each form of dystrophy and in particular cardiorespiratory and nutritional status ones will also be carried out.
Furthermore, "educational" support will also take place, instructing the patient about the benefits of maintaining an active lifestyle and regular practice of controlled physical activity.
The home therapeutic proposal will include the use of the tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHIMEYA) which allows to perform personalized games at home.
One aim is to offer continuity of care between the hospital structure and the home, also offering a concrete response to the inconsistent care guaranteed for these chronic developmental diseases by the National Health Service. The drafting of a personalized therapeutic plan, to be implemented within the home, would not only support the patient's motor needs, but would also guarantee a positive impact on a psychological level, strengthening the patient's participation in shared therapeutic objectives and awareness of the same. This pilot project aims to evaluate the effectiveness of a 6-month tele-rehabilitation program for continuity of care in a population of subjects suffering from neuromuscular pathology. The primary outcome will then be integrated with an assessment of tolerance of the path and usability and acceptability of the tele-rehabilitation system used.
Each patient will carry out a series of evaluation and training sessions (15 sessions) with a physiotherapist for the drafting of a personalized treatment plan that subsequently will be carried out "independently" at domicile.
During these days, periodic clinical-instrumental evaluations indicated by the specific guidelines for each form of dystrophy and in particular cardiorespiratory and nutritional status ones will also be carried out.
Furthermore, "educational" support will also take place, instructing the patient about the benefits of maintaining an active lifestyle and regular practice of controlled physical activity.
The home therapeutic proposal will include the use of the tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHIMEYA) which allows to perform personalized games at home.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: