Multiple SclerosisLIDONCT07502066
Clinical Efficacy of a telerehabilItation Protocol, for the Improvement of Balance in Degenerative Neurological Diseases
A study testing Telerehabilitation Treatment and Conventional Treatment in people with Multiple Sclerosis and Parkinson Disease, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial summary
The goal of this one blind-randomized controlled clinical trial is to evaluate the clinical effectiveness of a telerehabilitation (TR) protocol focusing on balance rehabilitation in patients with neurodegenerative diseases (Parkinson's Disease, Multiple Sclerosis). The secondary objectives of the study are: 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Sclerosis, Parkinson Disease
- What is being tested?
- Telerehabilitation Treatment and Conventional Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2021to 31 Dec 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Possession of an ADSL internet connection with a flat rate or, in the case of a pay-as-you-go tariff, with an availability of at least 20 Gigabytes/month.
- PARKINSON'S DISEASE:
- Patients with Parkinson's disease, according to the criteria of the UK Parkinson's Disease Society Brain Bank, in stabilised pharmacological treatment with L-Dopa or dopamine agonists and with a Hoehn \& Yahr scale score between 1.5 and 2.5;
- Patients presenting a score ≤ 2 in the 'freezing when walking' subitem of section II of the UPDRS;
- Patients presenting a score ≤ 2 in both duration and disability in the "dyskinesias" sub-item of section IV of the UPDRS.
- MULTIPLE SCLEROSIS
- Subjects with Multiple Sclerosis (MS) in the relapsing remitting (RRMS) or secondary progressive (SPMS) forms, according to the criteria of MC Donald 2010 [14], under stable drug treatment and with Expanded Disability Status Scale (EDSS) score ≤ 6.5;
- At the time of inclusion, at least 3 months have elapsed since the last relapse.
Who cannot join
- All patients will be excluded from the study who, in association with the diagnosis of the diseases listed above, have the following comorbidities diagnosed and documented in the medical records
- Unstabilised fractures;
- Diagnosis of major depression;
- Severe deficits in visual acuity and hearing perception;
- Dementia;
- Epilepsy not controlled pharmacologically;
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- Ideomotor apraxia;
- Neglect;
- Severe impairment of verbal comprehension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of a teLerehabilItation Protocol, for the Improvement of Balance in Degenerative neurOlogical Diseases
The goal of this one blind-randomized controlled clinical trial is to evaluate the clinical effectiveness of a telerehabilitation (TR) protocol focusing on balance rehabilitation in patients with neurodegenerative diseases (Parkinson's Disease, Multiple Sclerosis).
The secondary objectives of the study are:
Read more
- To evaluate the effects of clinical treatment on Health-Related Quality of Life (HRQOL) outcomes.
- To collect data on process measures: user needs (patients and caregivers), treatment adherence, usability, satisfaction, technological acceptance.
Participants will perform 20 rehabilitation session (physiotherapy) for balance improvement. Experimental group patients will be trheated through tele-rehabilitation performing exercise with an hospital physiotherapist.
Researchers will compare telerehabilitation group to usual care group to see if there is a significant improvement in motor function, particularly in balance and mobility tests, as well as an improvement in quality of life.
Read the detailed description
Single-blind randomised controlled clinical trial. A sample of 36 consecutive patients (18 per group) suffering from Multiple Sclerosis (N=18, 9 per group) and Parkinson's Disease (N=18, 9 per group), admitted to the San Camillo IRCCS Hospital in Venice in ordinary inpatient or outpatient care, who still need home rehabilitation, will be enrolled. patients will be randomised to receive either TR or usual care, based on an allocation generated by the website: "Sealed Envelope.com". After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3). The rehabilitation modality provided by the IRCCS in telerehabilitation is based on virtual reality modalities. In particular, the experimental treatment under study involves the use of the VRRS-TR system (Khymeia Group s.r.l, Noventa Padovana), which consists of
- n.1 Tablet complete with keyboard, power supply, telerehabilitation application (Virtual Reality Rehabilitation System- VRRS);
- no.1 multi-USB device with cable for USB-mini port
- n.1 video camera;
- no.1 wide-angle lens and its attachment;
- no.1 K-wand;
- no.2 KHIMU wireless inertial sensors with power supply
- 1 USB dongle for communication with KHIMU sensors
- n.7 Velcro strips These technologies will be delivered to the patient and will be used at home, through a two-way on-line connection by means of Synchronous Telerehabilitation, with an IRCCS physiotherapist, who will deliver the treatments through a dedicated workstation (Telecokpit), with which it will be possible to manage the patient's tablet through the "Teamviewer" app, interacting with the latter and monitoring the execution of the exercises through the videoconference implemented in the system.
The virtual environment makes it possible to administer a high dose of repetitions of the movement of interest; for each exercise, the quality of execution is monitored in real time, i.e. through the return of feedback to the subject through visual, acoustic and vocal indications. Finally, various parameters, such as the distance of the targets to be reached, the sensitivity, the number of repetitions and the dwell time on the different targets, allow the difficulty of the exercise to be increased or decreased. In order to perform the rehabilitation protocol in telerehabilitation, inertial sensors (KhyMU) are used, which are applied to the part of the body that will become the effector of the movement. The sensors are applied using special elastic bands on the front part of the trunk and the front part of the thighs/legs/arms. Depending on the movement to be trained, the therapist decides whether to use one sensor or both.The exercises proposed to the control group will be performed by the latter at home, in self-treatment. Type, intensity, duration and objectives of these exercises are structured to be as similar and homogeneous as possible to those performed by means of the VRRS system in Telerehabilitation. In order to carry out the therapies, the patient will be given a booklet with a precise description of the exercises to be performed accompanied by explanatory pictures. This file is created through the website: www.physiotherapyexercises.com. On a weekly basis, a physiotherapist will contact the patient by telephone to inquire about the progress of the therapies, giving indications on how to modify the modalities, number of repetitions, duration and difficulty of the exercises, maintaining the logic of incremental training adopted in the TR group protocol. The patient will also be provided with a monitoring diary of the activities performed, corresponding to the automatic reporting system implemented in the VRRS system, used instead for the TR group.
Follow-up (T3) At the end of the treatment protocol, two months after the final evaluation (T2), a Follow-Up will be carried out by means of a brief telephone survey to monitor the state of health, autonomy in ADLs, number of falls and perception of safety with respect to one's own balance of the patients enrolled in this project.
- Conditions
- Multiple Sclerosis, Parkinson Disease
- Being tested
- Telerehabilitation Treatment, Conventional Treatment
- Keywords
- Telerehabilitation, Balance Treatment, remote rehabilitation, remote monitoring
- Medical subject headings
- Multiple Sclerosis, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation TreatmentOther
Also called remote rehabilitation
The treatment will last 4 weeks; each session will be1 hour, to be performed five times a week. Patients in the Telerehabilitation group will perform the same balance rehabilitation protocol as the controls, through the telerehabilitation system implemented by the IRCCS, which allows them to perform rehabilitation treatments at home, monitored by a hospital physiotherapist. Both groups will carry out a clinical evaluation before and after the treatments and will be contacted again briefly two months after the end of the treatment to ascertain the maintenance of the results obtained.
Conventional TreatmentOther
Also called usual care treatment
The conventional treatment group will perform a programme of exercises, specific for balance, contained in a booklet, in which there is a description of the activities, accompanied by explanatory pictures. On a weekly basis, a physiotherapist will contact the individuals in this group by telephone to inquire about the progress of the therapy, and provide information on how to possibly modify the mode, number of repetitions, duration and difficulty of the exercises. In addition, the patient will be provided with a diary to monitor the activities performed. The treatment will last four weeks; each session will be one hour, to be performed five times a week.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group- Multiple Sclerosis (TR-MS) | Experimental | After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3). The rehabilitation modality provided by the IRCCS in telerehabilitation is based on virtual reality modalities. In particular, the experimental treatment under study involves the use of the VRRS-TR system (Khymeia Group s.r.l, Noventa Padovana). Every session will last 1h and will be done 5 times/week for 4 week. Receives: Other: Telerehabilitation Treatment |
| Control Group- Multiple Sclerosis (CG-MS) | Active comparator | After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3).Every session will last 1h and will be done 5 times/week for 4 week.The exercises proposed to the control group will be performed by the patient at home, in self-treatment.In order to carry out the therapies, the patient will be given a booklet with a precise description of the exercises to be performed accompanied by explanatory pictures. This file is created through the website: www.physiotherapyexercises.com. On a weekly basis, a physiotherapist will contact the patient by telephone to inquire about the progress of the therapies. The patient will also be provided with a monitoring diary of the activities performed, corresponding to the automatic reporting system implemented in the VRRS system, used instead for the TR group. Receives: Other: Conventional Treatment |
| Telerehabilitation Group- Parkinson's Disease (TR-PD) | Experimental | After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3). Every session will last 1h and will be done 5 times/week for 4 week.The rehabilitation modality provided by the IRCCS in telerehabilitation is based on virtual reality modalities. In particular, the experimental treatment under study involves the use of the VRRS-TR system (Khymeia Group s.r.l, Noventa Padovana). Receives: Other: Telerehabilitation Treatment |
| Control Group- Parkinson's Disease ( CG-PD) | Active comparator | After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3).Every session will last 1h and will be done 5 times/week for 4 week.The exercises proposed to the control group will be performed by the patient at home, in self-treatment.In order to carry out the therapies, the patient will be given a booklet with a precise description of the exercises to be performed accompanied by explanatory pictures. This file is created through the website: www.physiotherapyexercises.com. On a weekly basis, a physiotherapist will contact the patient by telephone to inquire about the progress of the therapies. The patient will also be provided with a monitoring diary of the activities performed, corresponding to the automatic reporting system implemented in the VRRS system, used instead for the TR group. Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The Berg Balance Scale (BBS) objectively assesses a patient's ability to safely maintain balance during 14 predetermined tasks. Each item is scored on a 5-point ordinal scale (0-4), with 0 indicating the lowest level of function and 4 the highest. The assessment takes approximately 20 minutes and excludes gait evaluation.
Possible scores range from 0 to 56, with higher scores indicating better balance function.
Measured: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Secondary outcomes (14)
Mini-Balance Evaluation System Test (Mini-BESTest)
The Mini-BESTest evaluates dynamic balance, functional mobility, and gait through 14 items across four sections: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.
Possible scores range from 0 to 28, with higher scores indicating better postural control and balance function.
Measured: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Functional Ambulation Classification (FAC)
FAC is a 6-point functional walking test that evaluates ambulation ability by determining the level of human support required when walking, regardless of assistive devices used.
Scores range from 0 (non-functional ambulator) to 5 (independent ambulator on any surface), with higher scores indicating better independence in ambulation.
Measured: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
5X Sit-to-Stand Test (5XSST)
5x Sit-To-Stand Test assesses functional lower extremity strength, transitional movements, balance, and fall risk, measuring the time taken to rise from a chair 5 times.
Scores are time in seconds (typically 5-30 seconds in adults), with lower time ndicating better lower limb strength and balance.
Measured: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Activities specific-Balance Confidence (ABC) -Scale
ABC scale is s a 16-item questionnaire measuring confidence in performing ambulatory activities without losing balance or feeling unsteady.
Scores range from 0% (no confidence) to 100% (complete confidence), with higher scores indicating greater balance confidence.
Measured: Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.
Barthel Index (BI)
BI is an ordinal scale measuring performance in 10 activities of daily living (ADL) and mobility, based on time and assistance required.
Scores range from 0 (total dependence) to 100 (complete independence), with higher scores indicating better functional independence.
Measured: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Six Minutes Walking Test (6MWT)
6MWT is a sub-maximal exercise test assessing aerobic capacity and endurance by measuring distance covered in 6 minutes.
Scores are distance in meters (typically 300-700m in adults), with greater distances indicating better endurance.
Measured: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline
Ten metres walking test (10MWT)
10MWT assesses walking speed in meters per second over a short distance to evaluate functional mobility, gait, and vestibular function.
Scores are time in seconds or speed in m/s (typically 0.8-1.5 m/s), with faster speeds (lower times) indicating better gait performance.
Measured: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Short-Form-36 health outcome (SF-36)
SF-36 is a self-reported measure of health-related quality of life across eight domains, yielding Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.
Domain scores range 0-100; PCS and MCS standardized to mean 50 (SD 10), with higher scores indicating better health status.
Measured: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Falls questionnaire (last year-last 2 months)
Self-produced questionnaire monitoring the number of falls occurring during the previous year and the two months prior to administration, including circumstances of falls.
Scores are count of falls (0 or more), with fewer falls indicating better outcome.
Measured: Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.
EuroQol-5 Dimensions, 3 Levels (EQ-5D-3L)
The EQ-5D is a self-completion questionnaire assessing health-related quality of life across five dimensions plus a visual analog scale, yielding an index score.
Index scores range from -0.594 (worse than dead) to 1 (perfect health), with higher scores indicating better health status.
Measured: Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.
Instrumental Activities of Daily Living (IADL)
IALS assesses ability to perform complex community-living tasks independently (Lawton scale).
Scores range from 0 (low functioning, dependent) to 8 (high functioning, independent), with higher scores indicating better independence.
Measured: Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.
Client Satisfaction Measure Questionnaire (SMQ)
Custom questionnaire measuring patient satisfaction with the received therapy. Scores range to be specified (e.g., 0-100 if Likert-based), with higher scores indicating greater satisfaction.
Measured: At Post-intervention (T2), approximately 6 weeks after baseline.
System Usability Scale (SUS)
The System Usability Scale (SUS) is a 10-item questionnaire providing a reliable measure of system usability.
Scores range from 0 to 100, with higher scores indicating better perceived usability (≥68 acceptable).
Measured: At Post-intervention (T2), approximately 6 weeks after baseline.
Technology acceptance questionnaire (TAM)
Custom questionnaire based on the Technology Acceptance Model (TAM), measuring patient acceptance of the technology used through constructs like perceived usefulness, perceived ease of use, and behavioral intention.
Individual items scored on a 7-point Likert scale (1=strongly disagree to 7=strongly agree); composite/mean scores range from 1 to 7, with higher scores indicating greater technology acceptance.
Measured: At Post-intervention (T2), approximately 6 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start14 Oct 2021
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Federico, IRCCS San Camillo, Venezia, Italy
- Investigators
- Sara Federico, PhD, Principal investigator, IRCCS San Camillo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502066
- Sponsor's protocol ID
- 2021.17
- Acronym
- LIDO
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chirra M, Marsili L, Wattley L, Sokol LL, Keeling E, Maule S, Sobrero G, Artusi CA, Romagnolo A, Zibetti M, Lopiano L, Espay AJ, Obeidat AZ, Merola A. Telemedicine in Neurological Disorders: Opportunities and Challenges. Telemed J E Health. 2019 Jul;25(7):541-550. doi: 10.1089/tmj.2018.0101. Epub 2018 Aug 23.
PubMed 30136898Yang WC, Wang HK, Wu RM, Lo CS, Lin KH. Home-based virtual reality balance training and conventional balance training in Parkinson's disease: A randomized controlled trial. J Formos Med Assoc. 2016 Sep;115(9):734-43. doi: 10.1016/j.jfma.2015.07.012. Epub 2015 Aug 13.
PubMed 26279172Khan F, Amatya B, Kesselring J, Galea M. Telerehabilitation for persons with multiple sclerosis. Cochrane Database Syst Rev. 2015 Apr 9;2015(4):CD010508. doi: 10.1002/14651858.CD010508.pub2.
PubMed 25854331
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of a teLerehabilItation Protocol, for the Improvement of Balance in Degenerative neurOlogical Diseases
- ClinicalTrials.gov ID
- NCT07502066
- Acronym / sponsor ID
- LIDO / 2021.17
- Conditions
- Multiple Sclerosis, Parkinson Disease
- Keywords
- Telerehabilitation, Balance Treatment, remote rehabilitation, remote monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this one blind-randomized controlled clinical trial is to evaluate the clinical effectiveness of a telerehabilitation (TR) protocol focusing on balance rehabilitation in patients with neurodegenerative diseases (Parkinson's Disease, Multiple Sclerosis).
The secondary objectives of the study are:
- To evaluate the effects of clinical treatment on Health-Related Quality of Life (HRQOL) outcomes.
- To collect data on process measures: user needs (patients and caregivers), treatment adherence, usability, satisfaction, technological acceptance.
Participants will perform 20 rehabilitation session (physiotherapy) for balance improvement. Experimental group patients will be trheated through tele-rehabilitation performing exercise with an hospital physiotherapist.
Researchers will compare telerehabilitation group to usual care group to see if there is a significant improvement in motor function, particularly in balance and mobility tests, as well as an improvement in quality of life.
Detailed description
Single-blind randomised controlled clinical trial. A sample of 36 consecutive patients (18 per group) suffering from Multiple Sclerosis (N=18, 9 per group) and Parkinson's Disease (N=18, 9 per group), admitted to the San Camillo IRCCS Hospital in Venice in ordinary inpatient or outpatient care, who still need home rehabilitation, will be enrolled. patients will be randomised to receive either TR or usual care, based on an allocation generated by the website: "Sealed Envelope.com". After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3). The rehabilitation modality provided by the IRCCS in telerehabilitation is based on virtual reality modalities. In particular, the experimental treatment under study involves the use of the VRRS-TR system (Khymeia Group s.r.l, Noventa Padovana), which consists of
- n.1 Tablet complete with keyboard, power supply, telerehabilitation application (Virtual Reality Rehabilitation System- VRRS);
- no.1 multi-USB device with cable for USB-mini port
- n.1 video camera;
- no.1 wide-angle lens and its attachment;
- no.1 K-wand;
- no.2 KHIMU wireless inertial sensors with power supply
- 1 USB dongle for communication with KHIMU sensors
- n.7 Velcro strips These technologies will be delivered to the patient and will be used at home, through a two-way on-line connection by means of Synchronous Telerehabilitation, with an IRCCS physiotherapist, who will deliver the treatments through a dedicated workstation (Telecokpit), with which it will be possible to manage the patient's tablet through the "Teamviewer" app, interacting with the latter and monitoring the execution of the exercises through the videoconference implemented in the system.
The virtual environment makes it possible to administer a high dose of repetitions of the movement of interest; for each exercise, the quality of execution is monitored in real time, i.e. through the return of feedback to the subject through visual, acoustic and vocal indications. Finally, various parameters, such as the distance of the targets to be reached, the sensitivity, the number of repetitions and the dwell time on the different targets, allow the difficulty of the exercise to be increased or decreased. In order to perform the rehabilitation protocol in telerehabilitation, inertial sensors (KhyMU) are used, which are applied to the part of the body that will become the effector of the movement. The sensors are applied using special elastic bands on the front part of the trunk and the front part of the thighs/legs/arms. Depending on the movement to be trained, the therapist decides whether to use one sensor or both.The exercises proposed to the control group will be performed by the latter at home, in self-treatment. Type, intensity, duration and objectives of these exercises are structured to be as similar and homogeneous as possible to those performed by means of the VRRS system in Telerehabilitation. In order to carry out the therapies, the patient will be given a booklet with a precise description of the exercises to be performed accompanied by explanatory pictures. This file is created through the website: www.physiotherapyexercises.com. On a weekly basis, a physiotherapist will contact the patient by telephone to inquire about the progress of the therapies, giving indications on how to modify the modalities, number of repetitions, duration and difficulty of the exercises, maintaining the logic of incremental training adopted in the TR group protocol. The patient will also be provided with a monitoring diary of the activities performed, corresponding to the automatic reporting system implemented in the VRRS system, used instead for the TR group.
Follow-up (T3) At the end of the treatment protocol, two months after the final evaluation (T2), a Follow-Up will be carried out by means of a brief telephone survey to monitor the state of health, autonomy in ADLs, number of falls and perception of safety with respect to one's own balance of the patients enrolled in this project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group- Multiple Sclerosis (TR-MS) | Experimental | Other: Telerehabilitation TreatmentAfter discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3). The rehabilitation modality provided by the IRCCS in telerehabilitation is based on virtual reality modalities. In particular, the experimental treatment under study involves the use of the VRRS-TR system (Khymeia Group s.r.l, Noventa Padovana). Every session will last 1h and will be done 5 times/week for 4 week. |
| Control Group- Multiple Sclerosis (CG-MS) | Active comparator | Other: Conventional TreatmentAfter discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3).Every session will last 1h and will be done 5 times/week for 4 week.The exercises proposed to the control group will be performed by the patient at home, in self-treatment.In order to carry out the therapies, the patient will be given a booklet with a precise description of the exercises to be performed accompanied by explanatory pictures. This file is created through the website: www.physiotherapyexercises.com. On a weekly basis, a physiotherapist will contact the patient by telephone to inquire about the progress of the therapies. The patient will also be provided with a monitoring diary of the activities performed, corresponding to the automatic reporting system implemented in the VRRS system, used instead for the TR group. |
| Telerehabilitation Group- Parkinson's Disease (TR-PD) | Experimental | Other: Telerehabilitation TreatmentAfter discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3). Every session will last 1h and will be done 5 times/week for 4 week.The rehabilitation modality provided by the IRCCS in telerehabilitation is based on virtual reality modalities. In particular, the experimental treatment under study involves the use of the VRRS-TR system (Khymeia Group s.r.l, Noventa Padovana). |
| Control Group- Parkinson's Disease ( CG-PD) | Active comparator | Other: Conventional TreatmentAfter discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3).Every session will last 1h and will be done 5 times/week for 4 week.The exercises proposed to the control group will be performed by the patient at home, in self-treatment.In order to carry out the therapies, the patient will be given a booklet with a precise description of the exercises to be performed accompanied by explanatory pictures. This file is created through the website: www.physiotherapyexercises.com. On a weekly basis, a physiotherapist will contact the patient by telephone to inquire about the progress of the therapies. The patient will also be provided with a monitoring diary of the activities performed, corresponding to the automatic reporting system implemented in the VRRS system, used instead for the TR group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Possession of an ADSL internet connection with a flat rate or, in the case of a pay-as-you-go tariff, with an availability of at least 20 Gigabytes/month.
- Patients with Parkinson's disease, according to the criteria of the UK Parkinson's Disease Society Brain Bank, in stabilised pharmacological treatment with L-Dopa or dopamine agonists and with a Hoehn \& Yahr scale score between 1.5 and 2.5;
- Patients presenting a score ≤ 2 in the 'freezing when walking' subitem of section II of the UPDRS;
- Patients presenting a score ≤ 2 in both duration and disability in the "dyskinesias" sub-item of section IV of the UPDRS.
- MULTIPLE SCLEROSIS
Key exclusion criteria (9 listed)
- All patients will be excluded from the study who, in association with the diagnosis of the diseases listed above, have the following comorbidities diagnosed and documented in the medical records
- Unstabilised fractures;
- Diagnosis of major depression;
- Severe deficits in visual acuity and hearing perception;
- Dementia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation TreatmentAlso: remote rehabilitationThe treatment will last 4 weeks; each session will be1 hour, to be performed five times a week. Patients in the Telerehabilitation group will perform the same balance rehabilitation protocol as the controls, through the telerehabilitation system implemented by the IRCCS, which allows them to perform rehabilitation treatments at home, monitored by a hospital physiotherapist. Both groups will carry out a clinical evaluation before and after the treatments and will be contacted again briefly two months after the end of the treatment to ascertain the maintenance of the results obtained. | Other | Telerehabilitation Group- Multiple Sclerosis (TR-MS), Telerehabilitation Group- Parkinson's Disease (TR-PD) |
| Conventional TreatmentAlso: usual care treatmentThe conventional treatment group will perform a programme of exercises, specific for balance, contained in a booklet, in which there is a description of the activities, accompanied by explanatory pictures. On a weekly basis, a physiotherapist will contact the individuals in this group by telephone to inquire about the progress of the therapy, and provide information on how to possibly modify the mode, number of repetitions, duration and difficulty of the exercises. In addition, the patient will be provided with a diary to monitor the activities performed. The treatment will last four weeks; each session will be one hour, to be performed five times a week. | Other | Control Group- Multiple Sclerosis (CG-MS), Control Group- Parkinson's Disease ( CG-PD) |
Primary outcome
Berg Balance Scale
Time frame: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
The Berg Balance Scale (BBS) objectively assesses a patient's ability to safely maintain balance during 14 predetermined tasks. Each item is scored on a 5-point ordinal scale (0-4), with 0 indicating the lowest level of function and 4 the highest. The assessment takes approximately 20 minutes and excludes gait evaluation. Possible scores range from 0 to 56, with higher scores indicating better balance function.
14 secondary outcomes
Mini-Balance Evaluation System Test (Mini-BESTest)
Time frame: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Functional Ambulation Classification (FAC)
Time frame: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
5X Sit-to-Stand Test (5XSST)
Time frame: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Activities specific-Balance Confidence (ABC) -Scale
Time frame: Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.
Barthel Index (BI)
Time frame: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Six Minutes Walking Test (6MWT)
Time frame: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline
Ten metres walking test (10MWT)
Time frame: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Short-Form-36 health outcome (SF-36)
Time frame: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Falls questionnaire (last year-last 2 months)
Time frame: Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.
EuroQol-5 Dimensions, 3 Levels (EQ-5D-3L)
Time frame: Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.
Instrumental Activities of Daily Living (IADL)
Time frame: Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.
Client Satisfaction Measure Questionnaire (SMQ)
Time frame: At Post-intervention (T2), approximately 6 weeks after baseline.
System Usability Scale (SUS)
Time frame: At Post-intervention (T2), approximately 6 weeks after baseline.
Technology acceptance questionnaire (TAM)
Time frame: At Post-intervention (T2), approximately 6 weeks after baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 30136898Chirra M, Marsili L, Wattley L, Sokol LL, Keeling E, Maule S, Sobrero G, Artusi CA, Romagnolo A, Zibetti M, Lopiano L, Espay AJ, Obeidat AZ, Merola A. Telemedicine in Neurological Disorders: Opportunities and Challenges. Telemed J E Health. 2019 Jul;25(7):541-550. doi: 10.1089/tmj.2018.0101. Epub 2018 Aug 23.
- Results publication: PubMed 26279172Yang WC, Wang HK, Wu RM, Lo CS, Lin KH. Home-based virtual reality balance training and conventional balance training in Parkinson's disease: A randomized controlled trial. J Formos Med Assoc. 2016 Sep;115(9):734-43. doi: 10.1016/j.jfma.2015.07.012. Epub 2015 Aug 13.
- Results publication: PubMed 25854331Khan F, Amatya B, Kesselring J, Galea M. Telerehabilitation for persons with multiple sclerosis. Cochrane Database Syst Rev. 2015 Apr 9;2015(4):CD010508. doi: 10.1002/14651858.CD010508.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Federico, PhD principal investigator
IRCCS San Camillo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation Treatment and Conventional Treatment in people with Multiple Sclerosis and Parkinson Disease, run by IRCCS San Camillo, Venezia, Italy at 1 site 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 8 inclusion and 9 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Berg Balance Scale (time frame: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.). 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 NCT07502066, which also lists 3 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 30 Mar 2026.