RCT on Telerehabilitation Efficacy in Parkinson's Disease

NCT05842577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2023-06-28

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

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).

Sponsors & Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

    collaborator OTHER
  • IRCCS National Neurological Institute "C. Mondino" Foundation

    collaborator OTHER
  • Fondazione Salvatore Maugeri

    collaborator OTHER
  • IRCCS San Camillo, Venezia, Italy

    collaborator OTHER
  • IRCCS Centro Neurolesi Bonino Pulejo

    collaborator OTHER
  • IRCCS San Raffaele Roma

    lead OTHER

Principal Investigators

  • Michela Goffredo, PhD · IRCCS San Raffaele Roma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05842577 on ClinicalTrials.gov