Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378203
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-19
Brief Title:
Rehabilitation in Muscular Dystrophies From the Hospital Facility to the Home Pilot Project RIMUDI
Sponsor:
IRCCS Eugenio Medea
Organization:
IRCCS Eugenio Medea
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 activityexercise 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 patients motor needs but would also guarantee a positive impact on a psychological level strengthening the patients 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 patients motor needs but would also guarantee a positive impact on a psychological level strengthening the patients 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?:
None