Clinical Efficacy of a telerehabilItation Protocol, for the Improvement of Balance in Degenerative Neurological Diseases (LIDO)

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:

1. To evaluate the effects of clinical treatment on Health-Related Quality of Life (HRQOL) outcomes.
2. 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis; Parkinson Disease
• Intervention / Treatment: Other: Telerehabilitation Treatment; Other: Conventional Treatment

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Venice-Lido, Italy, 30126
    • IRCCS San Camillo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• Ideomotor apraxia;
• Neglect;
• Severe impairment of verbal comprehension

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation Group- Multiple Sclerosis (TR-MS); 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.	Other: Telerehabilitation Treatment; 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.; Other Names: remote rehabilitation
Active Comparator: Control Group- Multiple Sclerosis (CG-MS); 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.	Other: Conventional 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.; Other Names: usual care treatment
Experimental: Telerehabilitation Group- Parkinson's Disease (TR-PD); 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).	Other: Telerehabilitation Treatment; 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.; Other Names: remote rehabilitation
Active Comparator: Control Group- Parkinson's Disease ( CG-PD); 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.	Other: Conventional 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.; Other Names: usual care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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.	At Post-intervention (T2), approximately 6 weeks after baseline.

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy
• Investigators: Principal Investigator: Sara Federico, PhD, IRCCS San Camillo Hospital

Publications and helpful links

General 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.
• Yang 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.
• Khan 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Telerehabilitation; remote monitoring; remote rehabilitation; Balance Treatment
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Multiple Sclerosis; Parkinson Disease; Health Services Administration; Delivery of Health Care; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Telemedicine; Patient Care Management; Telerehabilitation
• Other Study ID Numbers: 2021.17

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