Home Rehabilitation As Continuity of Care in MS (HoReConCareMS)

November 19, 2024 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

"Tele-riabilitazione in Sclerosi Multipla: Continuità Terapeutica Domiciliare Dopo Trattamento Di Neuro-riabilitazione Intensiva, Studio Randomizzato Controllato Con Piattaforma Integrata Per La Riabilitazione Del Disequilibrio"

RCT pilot study to evaluate adherence, satisfaction and feasibility in the use of a telemedicine station for balance rehabilitation in patients with multiple sclerosis.

The platform is designed as a tool for maintenance rehabilitation in a home setting and not as an alternative to intensive treatment in hospital, and is therefore compared to maintenance treatment as usual (TAU) after intensive treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Balance deficit represents one of the most frequent symptoms in patients with Multiple Sclerosis (PwMS) and one of the most disabling. Neuromotor rehabilitation is a fundamental tool for managing these symptoms: therapeutic exercise is currently the best choice for treating balance deficit. Once improvements has been achieved, this generally does not persist for a long time due to the underlying chronic-degenerative pathology: this reduction in clinical benefit, which can be graphically defined as a 'loss curve', is difficult to define due to individual differences, but it affects all MS patients. In recent years, new technologies are emerging, such as virtual reality and serious gaming, which are not presented as an alternative to intensive treatment but could find their ideal dimension in extensive treatment, allowing the patient to maintain the results achieved once the period of intensive treatment in a specialised rehabilitation facility is over. The specific objectives of this feasibility study are: to refine technical aspects of the Neuro Rehability system, to evaluate acceptability and satisfaction with its use by PwMS, to evaluate the recruitment process, adherence to the intervention, the number of drop-outs and identify potential problems, to evaluate the human resource requirements for the subsequent RCT study, to estimate the intervention effect and its variance necessary to calculate the appropriate sample size for the RCT.. Assessments will be carried out before the start (T0) and at the end (T1) of the treatment. The control group is asked to continue performing at home the normal physical activities that they may already be performing for the duration of the 12 weeks (TAU = treatment as usual). The experimental group is asked to perform the exercises of the Rehability platform, previously set up by the rehabilitation team on the basis of the training performed during the intensive rehabilitation period in the facility, at least 3 times a week and for at least 40 minutes per session. For both groups, no rehabilitation treatment will be possible except sphincter and phoniatric rehabilitation and psychological support. A descriptive statistical analysis will be used to describe the demographic and clinical characteristics of the sample. Standard data analysis techniques will be used to analyse the variables collected in both the feasibility study and the RCT. An electronic CRF will be set up to collect: clinical and demographic data on the recruited subjects; results of the tests/questionnaires.

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact Backup

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20122
        • Recruiting
        • IRCCS Istituto Auxologico Italiano
        • Contact:
      • Milan, MI, Italy, 20133
      • Milan, MI, Italy, 20148
        • Active, not recruiting
        • IRCCS Santa Maria nascente - Fondazione Don Gnocchi

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:

  • Expanded Disability Status Scale score between 3 and 6
  • Sensory Organisation Test Equitest values indicating balance impairment

Exclusion Criteria:

  • visual impairments
  • orthopedic impairments
  • inability to perform balance rehabilitation in stand up position

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional, telemedicine group
Patients will perform a 12 weeks rehabilitation program through telemedicine at home after intensive rehabilitation in hospital
Device: Telerehabilitation
Patients will perform a 12 weeks rehabilitation program through telemedicine at home after intensive rehabilitation in hospital. Balance rehabilitation program will be scheduled on the patients' need and ability to be performed three times a week with high levels of satisfaction and safety at home under remote control of the physical therapist.
Other Names:
  • Telemedicine
No Intervention: Control group
Patients will perform a 12 weeks maintenance rehabilitation program as usual care (TAU treatment as usual) at home after intensive rehabilitation in hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: Home rehabilitation, from the end of the intensive treatment to the follow up evaluation (12 weeks)
Safety in the use of the telemedicine system - number of sessions played and number of adverse events/number of dropouts
Home rehabilitation, from the end of the intensive treatment to the follow up evaluation (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telehealthcare Satisfaction Questionnaire (TSQ)
Time Frame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
Satisfaction levels perceived by patients in the use of the telemedicine system evaluating benefit, usability, self-concept, privacy, quality of life, comfort. Scores go from zero to 4 (zero is equivalent to minimum benefit in using the telemedicine system, 4 is equivalent to maximum benefit).
From the end of the intensive treatment to the follow up evaluation (12 weeks)
Telehealthcare Usability Questionnaire (TUQ)
Time Frame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
Satisfaction levels perceived by operators in the use of the telemedicine system evaluating twenty-one items about the usability of the system. Scores evaluate the level of agreement with statements about the system and go from zero (totally disagree) to 7 (totally agree).
From the end of the intensive treatment to the follow up evaluation (12 weeks)
Timed Up and Go test (TUG)
Time Frame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
Pre and post intervention assessment of mobility, balance, walking ability, and fall risk. Patients have to complete a sit to stand from a set chair and walk for 7 meters, turn around and sit down again, the score is the time needed to complete the test (seconds).
From the end of the intensive treatment to the follow up evaluation (12 weeks)
Timed 10-Meter Walk Test
Time Frame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
Pre and post intervention assessment of walking ability in terms of time (seconds) and steps necessary to complete a 10 meters path.
From the end of the intensive treatment to the follow up evaluation (12 weeks)
Equiscale test
Time Frame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
Pre and post intervention assessment of balance. Patients have to complete eight items evaluation static and dynamic balance (i.e. sit to stand, stand still with open and closed eyes) with a score from zero to 2 (zero is considered as not able to complete, 1 is partially able, 2 is totally able), total score is 16 points.
From the end of the intensive treatment to the follow up evaluation (12 weeks)
12-Item Multiple Sclerosis Walking Scale
Time Frame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a self-report measure of the impact of MS on the individual's walking ability. The scoring provides options 1-5 for each item, with 1 meaning no limitation and 5 meaning extreme limitation on the gait-related item. Total score is 60. Final score is calculated as a percentage of walking impairment (score x 100/60).
From the end of the intensive treatment to the follow up evaluation (12 weeks)
Multiple Sclerosis Quality of Life Questionnaire-54 (MSQoL-54)
Time Frame: From the end of the intensive treatment to the follow up evaluation (12 weeks)

The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary.

Multiple Sclerosis Quality of Life-54 (MSQOL-54) There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores.
From the end of the intensive treatment to the follow up evaluation (12 weeks)
Modified Fatigue Impact Scale (M-FIS)
Time Frame: From the end of the intensive treatment to the follow up evaluation (12 weeks)

The MFIS is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives.

Scoring the MFIS Items on the MFIS can be aggregated into three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities.

Physical Subscale can range from 0 to 36. It is computed by adding raw scores on the following items: 4+6+7+10+13+14+17+20+21.

Cognitive Subscale can range from 0 to 40. It is computed by adding raw scores on the following items: 1+2+3+5+11+12+15+16+18+19.

Psychosocial Subscale can range from 0 to 8. It is computed by adding raw scores on the following items: 8+9.

Total MFIS Score The total MFIS score can range from 0 to 84. It is computed by adding scores on the physical, cognitive, and psychosocial subscales.
From the end of the intensive treatment to the follow up evaluation (12 weeks)
Patient Health Engagement scale (PHE scale)
Time Frame: From the end of the intensive treatment to the follow up evaluation (12 weeks)

The Patient Health Engagement Model (PHE Model) is a psychological engagement model that allows to diagnose and study the experience of active engagement of patients in its prevention and treatment pathway.

Scoring is referred to five statements about the engagement level of the patient. Scores go from zero (less level of engagment) to 7 (higher level of engagement) and the total score is 35.
From the end of the intensive treatment to the follow up evaluation (12 weeks)

Collaborators and Investigators

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

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Collaborators

Fondazione Don Carlo Gnocchi Onlus
Istituto Auxologico Italiano

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)

November 6, 2024

Primary Completion (Estimated)

November 6, 2025

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Estimated)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HoReConCareMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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