Clincosm LogoSign in Get a demo

REPORT: RCT on Telerehabilitation Efficacy in Parkinson's Disease

Sponsor
IRCCS San Raffaele Roma (Other)
Overall Status
Completed
CT.gov ID
NCT05842577
Collaborator
Fondazione Don Carlo Gnocchi Onlus (Other), IRCCS National Neurological Institute "C. Mondino" Foundation (Other), Fondazione Salvatore Maugeri (Other), IRCCS San Camillo, Venezia, Italy (Other), IRCCS Centro Neurolesi "Bonino-Pulejo" (Other)
94
Enrollment
6
Locations
2
Arms
42
Actual Duration (Months)
15.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)
  • Other: At-home conventional rehabilitation
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is a multicentre, single-blind (evaluator), Randomized Controlled Trial (RCT)This study is a multicentre, single-blind (evaluator), Randomized Controlled Trial (RCT)
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Non-immersive Virtual Reality-based Telerehabilitation in Parkinson's Disease: a Multicentre Randomized Controlled Trial
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telerehabilitation Group (TG)

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).

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.
Active Comparator: Control Group (CG)

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.

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).
Other Names:
  • Structured self-administered exercises

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Bonino-Pulejo Messina Italy
    2 IRCCS Fondazione Don Carlo Gnocchi ONLUS Milan Italy
    3 IRCCS Mondino Foundation Pavia Italy
    4 IRCCS San Raffaele Roma Rome Italy 00166
    5 IRCCS San Camillo Hospital Venice Italy
    6 ICS Maugeri SB IRCCS Veruno Veruno Italy

    Sponsors and Collaborators

    • IRCCS San Raffaele Roma
    • Fondazione Don Carlo Gnocchi Onlus
    • IRCCS National Neurological Institute "C. Mondino" Foundation
    • Fondazione Salvatore Maugeri
    • IRCCS San Camillo, Venezia, Italy
    • IRCCS Centro Neurolesi "Bonino-Pulejo"

    Investigators

    • Principal Investigator: Michela Goffredo, PhD, IRCCS San Raffaele Roma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    IRCCS San Raffaele Roma
    ClinicalTrials.gov Identifier:
    NCT05842577
    Other Study ID Numbers:
    • REPORT
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by IRCCS San Raffaele Roma
    Telerehabilitation
    Parkinson
    Balance
    Continuity of Care
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of May 6, 2023