NCT05842577

RCT on Telerehabilitation Efficacy in Parkinson's Disease

Efficacy of Non-immersive Virtual Reality-based Telerehabilitation in Parkinson's Disease: a Multicentre Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: IRCCS San Raffaele Roma · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)	The motor exercises were performed using inertial sensors for the acquisition and processing of the movement performed by the patient. The patient was trained to perform these exercises using visual and auditory feedback in a serious game environment. The exercises were aimed at the rehabilitation of balance and at the improvement of motor performance in lower limbs (e.g., maintaining balance on one leg, marching in place, standing on tiptoe, squatting, etc.). The therapists involved in the study customized the protocol of exercises in TR mode according to the characteristics and needs of the subject.
OTHER	At-home conventional rehabilitation	The CG rehabilitation was an active comparator treatment and consisted of a written home-based self-administered booklet with conventional motor activities tailored for each subject. The motor activities were chosen and adapted from a specialized manual. The motor exercises were aimed at the rehabilitation of balance and at the improvement of motor performance in lower limbs (e.g., maintaining balance on one leg, marching in place, standing on tiptoe, squatting, etc).

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2023-05-06
• Last updated: 2023-06-28

Locations

6 sites across 1 country: Italy