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Parkinson DiseaseREPORTNCT05842577

RCT on Telerehabilitation Efficacy in Parkinson's Disease

A study testing VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy) and At-home conventional rehabilitation in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 6 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy) and At-home conventional rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
6 sitesItaly
Study dates
1 Jul 2018to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 ;
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  • stabilized drug treatment;
  • sufficient cognitive and linguistic level to understand and comply with study procedures;
  • sign informed consent.

Who cannot join

  • other neurological pathologies, psychiatric complications, or personality disorders;
  • blurred or low vision problems;
  • hearing and speech impairment affecting participation in the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Italy6 sites

  • IRCCS Bonino-Pulejo

    Messina

  • IRCCS Fondazione Don Carlo Gnocchi ONLUS

    Milan

  • IRCCS Mondino Foundation

    Pavia

  • IRCCS San Raffaele Roma

    Rome, 00166

  • IRCCS San Camillo Hospital

    Venice

  • ICS Maugeri SB IRCCS Veruno

    Veruno

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy), At-home conventional rehabilitation
Keywords
Telerehabilitation, Parkinson, Balance, Continuity of Care
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)Device

    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.

  • At-home conventional rehabilitationOther

    Also called Structured self-administered exercises

    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).

Study groups in NCT05842577
Study groupRoleWhat they receive
Telerehabilitation Group (TG)ExperimentalThe 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).
Receives: Device: VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)
Control Group (CG)Active comparatorThe 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.
Receives: Other: At-home conventional rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the mini-Balance Evaluation Systems Test (mini-BESTest)

    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.

    Measured: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)]

Secondary outcomes (3)

  1. Change in the Timed Up and Go test (TUG)

    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.

    Measured: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)]

  2. Change in the 6-minute WalkTest (6mWT)

    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.

    Measured: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)]

  3. Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - part III

    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.

    Measured: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks, T1)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start1 Jul 2018
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a multicentre, single-blind (evaluator), Randomized Controlled Trial (RCT)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05842577
Sponsor's protocol ID
RP 01/18
Acronym
REPORT
Status last verified
Jun 2023
First submitted
24 Apr 2023
Last updated
28 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vellata C, Belli S, Balsamo F, Giordano A, Colombo R, Maggioni G. Effectiveness of Telerehabilitation on Motor Impairments, Non-motor Symptoms and Compliance in Patients With Parkinson's Disease: A Systematic Review. Front Neurol. 2021 Aug 26;12:627999. doi: 10.3389/fneur.2021.627999. eCollection 2021.

    PubMed 34512495

  • Barbour PJ, Arroyo J, High S, Fichera LB, Staska-Pier MM, McMahon MK. Telehealth for patients with Parkinson's disease: delivering efficient and sustainable long-term care. Hosp Pract (1995). 2016;44(2):92-7. doi: 10.1080/21548331.2016.1166922.

    PubMed 26982525

  • Cikajlo I, Hukic A, Dolinsek I, Zajc D, Vesel M, Krizmanic T, Blazica B, Biasizzo A, Novak F, Peterlin Potisk K. Can telerehabilitation games lead to functional improvement of upper extremities in individuals with Parkinson's disease? Int J Rehabil Res. 2018 Sep;41(3):230-238. doi: 10.1097/MRR.0000000000000291.

    PubMed 29757774

Questions about this trial

What is this clinical trial studying?

A study testing VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy) and At-home conventional rehabilitation in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 6 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05842577, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.

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