Efficacy of Non-immersive Virtual Reality-based Telerehabilitation in Parkinson's Disease: a Multicentre Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- IRCCS San Raffaele Roma
- Enrollment
- 94
- Locations
- 6
- Primary Endpoint
- Change in the mini-Balance Evaluation Systems Test (mini-BESTest)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Change in the mini-Balance Evaluation Systems Test (mini-BESTest)
Time Frame: 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 Outcomes
- Change in the Timed Up and Go test (TUG)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)])
- Change in the 6-minute WalkTest (6mWT)(Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)])
- 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)])