Rehabilitation in Muscular Dystrophies From the Hospital Facility to the Home: Pilot Project [RIMUDI]

NCT ID: NCT06378203

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2025-04-15

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.

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.

Conditions

Muscular Dystrophies; Limb Girdle Muscular Dystrophy; Facio-Scapulo-Humeral Dystrophy; Becker Muscular Dystrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Limb GIrdle Muscular Dystrophy

Open label study one arm

Group Type: EXPERIMENTAL

tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA)

Intervention Type: OTHER

A personalized exercise plan following macro-areas of objectives:

• maintenance of muscle lengths with selective and/or prolonged static stretching exercises;
• maintenance/improvement of muscle trophism with selective and/or postural and/or functional muscle recruitment exercises at moderate intensity (approximately 65%-70% of the maximum);
• maintenance of respiratory muscle weakness with thoracic and/or diaphragmatic breathing exercises combined with muscle exercise;
• endurance training with walking, cycle ergometer (to be used with both the upper and lower limbs) and treadmill at moderate intensity (approximately 65%-70% of the maximum).

Home treatment will mostly take place with the KHYMEIA tele-rehabilitation system.

Interventions

tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA)

A personalized exercise plan following macro-areas of objectives:

• maintenance of muscle lengths with selective and/or prolonged static stretching exercises;
• maintenance/improvement of muscle trophism with selective and/or postural and/or functional muscle recruitment exercises at moderate intensity (approximately 65%-70% of the maximum);
• maintenance of respiratory muscle weakness with thoracic and/or diaphragmatic breathing exercises combined with muscle exercise;
• endurance training with walking, cycle ergometer (to be used with both the upper and lower limbs) and treadmill at moderate intensity (approximately 65%-70% of the maximum).

Home treatment will mostly take place with the KHYMEIA tele-rehabilitation system.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• strength values at the level of the main antigravity muscles > or equal to 3, according to the Medical Research Council (MRC) scale;
• independent walking in a protected (internal) environment, even with assistance;
• patients must have performed at least 1 clinical-functional evaluation at our facility in the year preceding the start of the trial.
• They must express compliance with joining the project and must not be followed from a physiotherapeutic point of view elsewhere during the 6 months of participation in the project.

Exclusion Criteria

• dilated or ischemic heart disease with Left Ventricle Ejection Fraction <50%;
• chronic respiratory failure with Forced Vital Capacity < 40% predicted, nocturnal oxygen desaturation - > 5% of nocturnal time spent with peripheral oxygen saturation levels < 90).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Scientific Institute IRCCS Eugenio Medea

Bosisio Parini, Lecco, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maria G D'Angelo

Role: CONTACT

grazia.dangelo@lanostrafamiglia.it

031877111 ext. +39

Facility Contacts

Maria G D'Angelo, MD

Role: primary

grazia.dangelo@lanostrafamiglia.it

031877111 ext. +39

References

Preisler N, Orngreen MC. Exercise in muscle disorders: what is our current state? Curr Opin Neurol. 2018 Oct;31(5):610-617. doi: 10.1097/WCO.0000000000000597.

Reference Type: BACKGROUND

PMID: 30036194 (View on PubMed)

Veenhuizen Y, Cup EHC, Jonker MA, Voet NBM, van Keulen BJ, Maas DM, Heeren A, Groothuis JT, van Engelen BGM, Geurts ACH. Self-management program improves participation in patients with neuromuscular disease: A randomized controlled trial. Neurology. 2019 Oct 29;93(18):e1720-e1731. doi: 10.1212/WNL.0000000000008393. Epub 2019 Sep 30.

Reference Type: BACKGROUND

PMID: 31570565 (View on PubMed)

Siciliano G, Simoncini C, Giannotti S, Zampa V, Angelini C, Ricci G. Muscle exercise in limb girdle muscular dystrophies: pitfall and advantages. Acta Myol. 2015 May;34(1):3-8.

Reference Type: BACKGROUND

PMID: 26155063 (View on PubMed)

Eagle M. Report on the muscular dystrophy campaign workshop: exercise in neuromuscular diseases Newcastle, January 2002. Neuromuscul Disord. 2002 Dec;12(10):975-83. doi: 10.1016/s0960-8966(02)00136-0. No abstract available.

Reference Type: BACKGROUND

PMID: 12467755 (View on PubMed)

Heutinck L, Jansen M, van den Elzen Y, van der Pijl D, de Groot IJM. Virtual Reality Computer Gaming with Dynamic Arm Support in Boys with Duchenne Muscular Dystrophy. J Neuromuscul Dis. 2018;5(3):359-372. doi: 10.3233/JND-180307.

Reference Type: BACKGROUND

PMID: 29991140 (View on PubMed)

Jansen M, de Groot IJ, van Alfen N, Geurts ACh. Physical training in boys with Duchenne Muscular Dystrophy: the protocol of the No Use is Disuse study. BMC Pediatr. 2010 Aug 6;10:55. doi: 10.1186/1471-2431-10-55.

Reference Type: BACKGROUND

PMID: 20691042 (View on PubMed)

Other Identifiers

MEDEA 1013

Identifier Type: -

Identifier Source: org_study_id