RCT on Telerehabilitation Efficacy in Parkinson's Disease (REPORT)

IRCCS San Raffaele Roma

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy); Other: At-home conventional rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05842577

RP 01/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

Telerehabilitation Group (TG)

Experimental group

Description:

The TG consisted of 30 sessions lasting approximately 45 minutes (3-5/week for 6-10 weeks) of motor, and cognitive rehabilitation exercises in non-immersive VR-based TR modality using the VRRS Tablet system (Khymeia Srl, Noventa Padovana, Italy).

Treatment:

Device: VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)

Control Group (CG)

Active Comparator group

Description:

The CG carried consisted of 30 sessions lasting approximately 45 minutes (3-5 days/week for, 6-10 weeks) of at-home conventional rehabilitation via structured self-administered exercises without the use of any technological devices.

Treatment:

Other: At-home conventional rehabilitation