Clinical trial NCT06699095: Home Rehabilitation As Continuity of Care in MS
Official title: "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"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Balance rehabilitation
Telemedicine
Home rehabilitation
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
Collaborators: name: Istituto Auxologico Italiano
name: Fondazione Don Carlo Gnocchi Onlus
First posted: 2024-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: Home rehabilitation, from the end of the intensive treatment to the follow up evaluation (12 weeks)
Secondary outcomes:
measure: Telehealthcare Satisfaction Questionnaire (TSQ)
timeFrame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
measure: Telehealthcare Usability Questionnaire (TUQ)
timeFrame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
measure: Timed Up and Go test (TUG)
timeFrame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
measure: Timed 10-Meter Walk Test
timeFrame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
measure: Equiscale test
timeFrame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
measure: 12-Item Multiple Sclerosis Walking Scale
timeFrame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
measure: Multiple Sclerosis Quality of Life Questionnaire-54 (MSQoL-54)
timeFrame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
measure: Modified Fatigue Impact Scale (M-FIS)
timeFrame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
measure: Patient Health Engagement scale (PHE scale)
timeFrame: From the end of the intensive treatment to the follow up evaluation (12 weeks)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Auxologico Italiano
state: MI
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
state: MI
city: Milan
country: Italy
facility: IRCCS Santa Maria nascente - Fondazione Don Gnocchi
state: MI
Study officials:
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