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

April 19, 2024 updated by: IRCCS Eugenio Medea

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Lecco
      • Bosisio Parini, Lecco, Italy, 23842

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:- definite genetic diagnosis of Limb Girdle Muscular Dystrophy: LGMD2A/R1(calpain 3 deficiency), LGMD2B/R2(dysferlin deficiency), LGMD2I/R9 (FKRP), LGMD2L /R11(ANOCTAMIN 5) or Facio Scapulo Humeral Dystrophy (FSHD) or Becker muscular dystrophy (BMD);

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Limb GIrdle Muscular Dystrophy
Open label study one arm
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minute walk test (6MWT)
Time Frame: 6 months : Modification from month 0 (baseline) to month 6
6 Minute Walk Test (measured in meters- normal range 500-600 meters in 6 minutes)
6 months : Modification from month 0 (baseline) to month 6
Motor Function Measure scale (MFM)
Time Frame: 6 months: Modification from month 0 (baseline) to month 6
MFM measures Motor function at 3 levels (D1 change position and transfers; D2 axial and proximal motor function; D3 distal motor function), Each i item is scored on a 4-point Likert scale from 0 (cannot initiate the task) to 3 (performs the task fully). Item scores are summed, and the raw score is transformed to an overall total score ranging from 0 (severe functional impairment) to 100 (no functional impairment). rated in % from 0 to 100 and an overall percentage is calculated , in %)
6 months: Modification from month 0 (baseline) to month 6
Performance of Upper Limb (PUL)
Time Frame: 6 Months: Modification from month 0 (baseline) to month 6
Performance of upper limb is a scale specifically designed to measure upper limb function in muscular dystrophy; there is an entry level item ranging from 0 to 6; the PUL scale test the proximal to distal progression of muscle weakness through three levels: high (shoulder domain), mid (elbow domain), and distal (wrist and finger domain); the PUL score (version 1.2) includes 22 items ; the overall scores ranges from 0 to 42
6 Months: Modification from month 0 (baseline) to month 6
Time up and go (TUG)
Time Frame: 6 months: Modification from month 0 (baseline) to month 6
Recording of the time required to stand up from a chair, walk for 3 meters and going back to the sitting position- normal range < 10 seconds
6 months: Modification from month 0 (baseline) to month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modification of fatigue and quality of life scales from T0 to T6
Time Frame: 6 months: Modification from month 0 (baseline) to month 6
Modified Fatigue Impact Scale (MFIS) composed by 3 sub scales (physical scale score final range from 0 to 36; COGNITIVE final range from 0 to 40; PSYCHOSOCIAL, final range score from 0 to 8) and 1 final total score ranging from 0 to 84
6 months: Modification from month 0 (baseline) to month 6
Short Form 36 (SF36)
Time Frame: 6 months: Modification from month 0 (baseline) to month 6
one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. Each item with a score ranging from 0 to 100
6 months: Modification from month 0 (baseline) to month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Eugenio Medea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEDEA 1013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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