RCT on Telerehabilitation Efficacy in Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Device: VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)Other: At-home conventional rehabilitation
- Registration Number
- NCT05842577
- Lead Sponsor
- IRCCS San Raffaele Roma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- 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.
- other neurological pathologies, psychiatric complications, or personality disorders;
- blurred or low vision problems;
- hearing and speech impairment affecting participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telerehabilitation Group (TG) VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy) 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). Control Group (CG) At-home conventional rehabilitation 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.
- Primary Outcome Measures
Name Time Method Change in the mini-Balance Evaluation Systems Test (mini-BESTest) Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)] The mini-BESTest is a shortened version of the Balance Evaluation Systems Test. It aims to target and identify 6 different balance control systems so that specific rehabilitation approaches can be designed for different balance deficits. The test was shortened based on factor analysis to include dynamic balance only and to improve clinical utilization. It is 36 items scale that evaluates Balance with total score of 28.
- Secondary Outcome Measures
Name Time Method Change in the Timed Up and Go test (TUG) Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)] The TUG test assesses mobility, balance, walking ability, and fall risk in older adults. It is a measure of function with correlates to balance and fall risk. The participant is asked to get up from the chair she/he is sitting in, walk the marked distance of 3 meters and return to her/his seat again. The elapsed time is recorded in seconds.
Change in the 6-minute WalkTest (6mWT) Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)] The 6mWT assesses the functional exercise capacity. The patient is asked to walk as long as possible for 6 minutes at a self-selected speed. The distance is recorded in meters.
Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - part III Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)] MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question, a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicated more severe symptoms of PD.
Trial Locations
- Locations (6)
IRCCS Mondino Foundation
🇮🇹Pavia, Italy
IRCCS Bonino-Pulejo
🇮🇹Messina, Italy
IRCCS Fondazione Don Carlo Gnocchi ONLUS
🇮🇹Milan, Italy
IRCCS San Raffaele Roma
🇮🇹Rome, Italy
IRCCS San Camillo Hospital
🇮🇹Venice, Italy
ICS Maugeri SB IRCCS Veruno
🇮🇹Veruno, Italy