NCT07502066

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

Clinical Efficacy of a teLerehabilItation Protocol, for the Improvement of Balance in Degenerative neurOlogical Diseases

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: IRCCS San Camillo, Venezia, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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. 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.

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

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2021-10-14
• Primary completion: 2026-12-01
• Completion: 2026-12-31
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Italy