Clinical trial NCT05842577: RCT on Telerehabilitation Efficacy in Parkinson's Disease
Official title: Efficacy of Non-immersive Virtual Reality-based Telerehabilitation in Parkinson's Disease: a Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Telerehabilitation
Parkinson
Balance
Continuity of Care
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
Collaborators: name: Fondazione Don Carlo Gnocchi Onlus
name: IRCCS National Neurological Institute "C. Mondino" Foundation
name: Fondazione Salvatore Maugeri
name: IRCCS San Camillo, Venezia, Italy
name: IRCCS Centro Neurolesi Bonino Pulejo
First posted: 2023-05-06
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a multicentre, single-blind (evaluator), Randomized Controlled Trial (RCT)
Primary purpose: TREATMENT

Brief summary: The implementation of regular prolonged, and effective rehabilitation in people with Parkinson's disease is essential for ensuring a good quality of life. However, the continuity of rehabilitation care may find barriers related to economic, geographic, and social issues. In these scenarios, telerehabilitation could be a possible solution to guarantee the continuity of care.

This trial aims to investigate the efficacy of non-immersive virtual reality-based telerehabilitation on postural stability in people with Parkinson's disease, compared to at-home conventional rehabilitation.

Detailed description: Parkinson's Disease (PD) is a chronic degenerative pathology characterized by both motor and non-motor symptoms that may have a significant long-term impact on Activities of Daily Living (ADL).

Subjects with PD need continuous, intensive, and tailored rehabilitation in order to improve motor function as well as their Quality of Life (QoL), and to reduce the risk of balance impairment and falls. Thus, the implementation of regular prolonged, and effective rehabilitation in people with PD is essential for ensuring well-being.

In this scenario, the delivery of rehabilitation services at distance, namely TeleRehabilitation (TR), is a possible solution to guarantee the continuity of care and physical exercise at home via digital healthcare.

Although the TR intervention has been proposed as a sustainable and innovative approach in people with PD, there are still conflicting results in the literature about its efficacy.

This study aims to investigate the efficacy of non-immersive VR-based TR on postural stability in people with PD, compared to at-home conventional rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Hoehn \& Yahr (H\&Y) score between ≤3 (ON-state);
* the absence of moderate and severe dyskinesias assessed by the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) with a score of items 4.1 and 4.2 \< 3;
* the absence of moderate and severe freezing episodes assessed by the MDS-UPDRS with a score of items 2.13 and 3.11 \< 3;
* the ability to perform the 6 Minutes Walking Test (6MWT) between 200 m and 600 m;
* age ≤ 80 years;
* the absence of cognitive impairment measured by the Montreal Cognitive Assessment (MoCA) total score≥17.54 ;
* stabilized drug treatment;
* sufficient cognitive and linguistic level to understand and comply with study procedures;
* sign informed consent.

Exclusion Criteria:

* other neurological pathologies, psychiatric complications, or personality disorders;
* blurred or low vision problems;
* hearing and speech impairment affecting participation in the study.

Primary outcomes:
measure: Change in the mini-Balance Evaluation Systems Test (mini-BESTest)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)]
Secondary outcomes:
measure: Change in the Timed Up and Go test (TUG)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)]
measure: Change in the 6-minute WalkTest (6mWT)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)]
measure: Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - part III
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)]
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Bonino-Pulejo
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi ONLUS
city: Pavia
country: Italy
facility: IRCCS Mondino Foundation
city: Rome
country: Italy
facility: IRCCS San Raffaele Roma
city: Venice
country: Italy
facility: IRCCS San Camillo Hospital
city: Veruno
country: Italy
facility: ICS Maugeri SB IRCCS Veruno
Study officials:
affiliation: IRCCS San Raffaele Roma
name: Michela Goffredo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vellata C, Belli S, Balsamo F, Giordano A, Colombo R, Maggioni G. Effectiveness of Telerehabilitation on Motor Impairments, Non-motor Symptoms and Compliance in Patients With Parkinson's Disease: A Systematic Review. Front Neurol. 2021 Aug 26;12:627999. doi: 10.3389/fneur.2021.627999. eCollection 2021.
citation: Barbour PJ, Arroyo J, High S, Fichera LB, Staska-Pier MM, McMahon MK. Telehealth for patients with Parkinson's disease: delivering efficient and sustainable long-term care. Hosp Pract (1995). 2016;44(2):92-7. doi: 10.1080/21548331.2016.1166922.
citation: Cikajlo I, Hukic A, Dolinsek I, Zajc D, Vesel M, Krizmanic T, Blazica B, Biasizzo A, Novak F, Peterlin Potisk K. Can telerehabilitation games lead to functional improvement of upper extremities in individuals with Parkinson's disease? Int J Rehabil Res. 2018 Sep;41(3):230-238. doi: 10.1097/MRR.0000000000000291.