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Multiple SclerosisHoReConCareMSNCT06699095

Home Rehabilitation as Continuity of Care in MS

A study testing Telerehabilitation in people with Multiple Sclerosis, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 3 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Telerehabilitation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesItaly
Study dates
6 Nov 2024to 15 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • IRCCS Istituto Auxologico Italiano

    Milan, MI, 20122

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, MI, 20133

  • IRCCS Santa Maria nascente - Fondazione Don Gnocchi

    Milan, MI, 20148

Other trials in Italy

About this study

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"

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.

Read the 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.

Being tested
Telerehabilitation
Keywords
Balance rehabilitation, Telemedicine, Home rehabilitation
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelerehabilitationDevice

    Also called Telemedicine

    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.

Study groups in NCT06699095
Study groupRoleWhat they receive
Interventional, telemedicine groupExperimentalPatients will perform a 12 weeks rehabilitation program through telemedicine at home after intensive rehabilitation in hospital
Receives: Device: Telerehabilitation
Control groupNo interventionPatients will perform a 12 weeks maintenance rehabilitation program as usual care (TAU treatment as usual) at home after intensive rehabilitation in hospital

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    Safety in the use of the telemedicine system - number of sessions played and number of adverse events/number of dropouts

    Measured: Home rehabilitation, from the end of the intensive treatment to the follow up evaluation (12 weeks)

Secondary outcomes (9)

  1. Telehealthcare Satisfaction Questionnaire (TSQ)

    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).

    Measured: From the end of the intensive treatment to the follow up evaluation (12 weeks)

  2. Telehealthcare Usability Questionnaire (TUQ)

    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).

    Measured: From the end of the intensive treatment to the follow up evaluation (12 weeks)

  3. Timed Up and Go test (TUG)

    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).

    Measured: From the end of the intensive treatment to the follow up evaluation (12 weeks)

  4. Timed 10-Meter Walk Test

    Pre and post intervention assessment of walking ability in terms of time (seconds) and steps necessary to complete a 10 meters path.

    Measured: From the end of the intensive treatment to the follow up evaluation (12 weeks)

  5. Equiscale test

    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.

    Measured: From the end of the intensive treatment to the follow up evaluation (12 weeks)

  6. 12-Item Multiple Sclerosis Walking Scale

    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).

    Measured: From the end of the intensive treatment to the follow up evaluation (12 weeks)

  7. Multiple Sclerosis Quality of Life Questionnaire-54 (MSQoL-54)

    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.

    Measured: From the end of the intensive treatment to the follow up evaluation (12 weeks)

  8. Modified Fatigue Impact Scale (M-FIS)

    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.

    Measured: From the end of the intensive treatment to the follow up evaluation (12 weeks)

  9. Patient Health Engagement scale (PHE scale)

    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.

    Measured: From the end of the intensive treatment to the follow up evaluation (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2024
  2. Study start6 Nov 2024
  3. Primary completion6 Nov 2025
  4. Study completion15 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Single group
Model description
Randomized controlled trial
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06699095
Sponsor's protocol ID
HoReConCareMS
Acronym
HoReConCareMS
Status last verified
Aug 2026
First submitted
12 Nov 2024
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Benzel E. Empowerment. World Neurosurg. 2022 Jan;157:xv. doi: 10.1016/j.wneu.2021.10.132. No abstract available.

    PubMed 34929787

  • Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.

    PubMed 21387374

  • Truijen S, Abdullahi A, Bijsterbosch D, van Zoest E, Conijn M, Wang Y, Struyf N, Saeys W. Effect of home-based virtual reality training and telerehabilitation on balance in individuals with Parkinson disease, multiple sclerosis, and stroke: a systematic review and meta-analysis. Neurol Sci. 2022 May;43(5):2995-3006. doi: 10.1007/s10072-021-05855-2. Epub 2022 Feb 17.

    PubMed 35175439

  • Yazgan YZ, Tarakci E, Tarakci D, Ozdincler AR, Kurtuncu M. Comparison of the effects of two different exergaming systems on balance, functionality, fatigue, and quality of life in people with multiple sclerosis: A randomized controlled trial. Mult Scler Relat Disord. 2020 Apr;39:101902. doi: 10.1016/j.msard.2019.101902. Epub 2019 Dec 21.

    PubMed 31924591

  • Cimino V, Chisari CG, Raciti G, Russo A, Veca D, Zagari F, Calabro RS, Patti F. Objective evaluation of Nintendo Wii Fit Plus balance program training on postural stability in Multiple Sclerosis patients: a pilot study. Int J Rehabil Res. 2020 Sep;43(3):199-205. doi: 10.1097/MRR.0000000000000408.

    PubMed 32371848

  • Celesti A, Cimino V, Naro A, Portaro S, Fazio M, Villari M, Calabro RS. Recent Considerations on Gaming Console Based Training for Multiple Sclerosis Rehabilitation. Med Sci (Basel). 2022 Feb 11;10(1):13. doi: 10.3390/medsci10010013.

    PubMed 35225946

  • Kim Y, Lai B, Mehta T, Thirumalai M, Padalabalanarayanan S, Rimmer JH, Motl RW. Exercise Training Guidelines for Multiple Sclerosis, Stroke, and Parkinson Disease: Rapid Review and Synthesis. Am J Phys Med Rehabil. 2019 Jul;98(7):613-621. doi: 10.1097/PHM.0000000000001174.

    PubMed 30844920

  • Garcia-Munoz C, Cortes-Vega MD, Heredia-Rizo AM, Martin-Valero R, Garcia-Bernal MI, Casuso-Holgado MJ. Effectiveness of Vestibular Training for Balance and Dizziness Rehabilitation in People with Multiple Sclerosis: A Systematic Review and Meta-Analysis. J Clin Med. 2020 Feb 21;9(2):590. doi: 10.3390/jcm9020590.

    PubMed 32098162

  • Donze C, Massot C. Rehabilitation in multiple sclerosis in 2021. Presse Med. 2021 Jun;50(2):104066. doi: 10.1016/j.lpm.2021.104066. Epub 2021 May 11.

    PubMed 33989721

  • Manjaly ZM, Harrison NA, Critchley HD, Do CT, Stefanics G, Wenderoth N, Lutterotti A, Muller A, Stephan KE. Pathophysiological and cognitive mechanisms of fatigue in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2019 Jun;90(6):642-651. doi: 10.1136/jnnp-2018-320050. Epub 2019 Jan 25.

    PubMed 30683707

  • Cameron MH, Nilsagard Y. Balance, gait, and falls in multiple sclerosis. Handb Clin Neurol. 2018;159:237-250. doi: 10.1016/B978-0-444-63916-5.00015-X.

    PubMed 30482317

  • Berrigan LI, Fisk JD, Patten SB, Tremlett H, Wolfson C, Warren S, Fiest KM, McKay KA, Marrie RA; CIHR Team in the Epidemiology and Impact of Comorbidity on Multiple Sclerosis (ECoMS). Health-related quality of life in multiple sclerosis: Direct and indirect effects of comorbidity. Neurology. 2016 Apr 12;86(15):1417-1424. doi: 10.1212/WNL.0000000000002564. Epub 2016 Mar 9.

    PubMed 26962068

  • Herrera WG. Vestibular and other balance disorders in multiple sclerosis. Differential diagnosis of disequilibrium and topognostic localization. Neurol Clin. 1990 May;8(2):407-20.

    PubMed 2193219

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation in people with Multiple Sclerosis, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: Home rehabilitation, from the end of the intensive treatment to the follow up evaluation (12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06699095, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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