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Parkinson's DiseaseTEMPONCT05773885

Telerehabilitation in People With Parkinson's Disease

A study testing VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy) and Conventional rehabilitation in people with Parkinson's Disease, run by IRCCS San Raffaele Roma at 2 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

Although TeleRehabilitation (TR) is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are still few studies in the literature on the use of TR as a rehabilitation tool in people… Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy) and Conventional rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
2 sitesItaly
Study dates
1 Sep 2022to 14 Oct 2026
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age between 30 and 80 years;
  • diagnosis of Parkinson's Disease according to the "Movement Disorders Society's diagnostic criteria";
  • Hoehn \& Yahr (H\&Y) score between 2 and 3 (ON-state);
  • absence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 ≤ 2;
  • absence of cognitive impairment measured by the MoCA total score ≥ 18;
  • stabilized drug treatment;
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  • have access to the Internet for TR;
  • have a caregiver available during rehabilitation sessions in TR;
  • have sufficient cognitive and linguistic level to understand and comply with study procedures;
  • sign informed consent.

Who cannot join

  • having any cognitive problems or low compliance that prevent using the TR system;
  • other neurological pathologies, psychiatric complications or personality disorders;
  • musculoskeletal diseases that impair movement;
  • presence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 > 2;
  • presence of cognitive impairment measured by the MoCA total score < 18;
  • severe cognitive or linguistic deficits (inability to understand and comply with study procedures);
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  • presence of blurred or low vision problems;
  • hearing and speech impairment affecting participation in the system;
  • absence of signature of the informed consent.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • San Raffaele Cassino

    Cassino, Frosinone, 03043

  • IRCCS San Raffaele Roma

    Rome, Italy, 00163

Other trials in Italy

About this study

Official title: Home Telerehabilitation Based on Serious Games for Continuity of Care in People With Parkinson's Disease

Although TeleRehabilitation (TR) is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are still few studies in the literature on the use of TR as a rehabilitation tool in people with Parkinson's Disease (PD). Therefore, further studies on the efficacy of TR in the management of motor and non-motor symptoms of PD are needed.

The study TEMPO aims at assessing the efficacy (in terms of autonomy in carrying out the activities of daily life) of a home TR program based on serious games in people with PD compared to conventional day-hospital treatment.

Read the detailed description

The scientific literature has shown that appropriate exercise can decrease some non-motor symptoms of PD such as fatigue, depression, apathy, and cognitive impairment, and it can positively affect motor performance. However, access to rehabilitation centers is often difficult, with logistic and economic barriers for those not living near a specialized hospital. In recent years, the use of technologies has considerably progressed, and, with the development of telemedicine systems, remote treatments have become a viable option for the management of patients with PD.

The TR has the potential to optimize the timing, intensity, and personalization of rehabilitation intervention and offers the opportunity for a flexible implementation of treatment protocols and the ability to monitor patient progress in real-time. In particular, for patients with neurological degenerative pathologies, who need periodical and tailored rehabilitation for the whole life, the TR has proved feasible and effective. The recent systematic review by Vellata found that the literature on TR in people with PD is limited. The published studies on TR for PD showed that it is feasible and effective in maintaining and/or improving some clinical and non-clinical aspects of PD such as: balance and walking, speech and voice, quality of life, patient satisfaction. However, although TR is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are still few studies in the literature on the use of TR as a rehabilitation tool in people with Parkinson's disease.

In this context, the efficacy of TR in the management of motor and non-motor symptoms of PD has to be further investigated.

Being tested
VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy), Conventional rehabilitation
Keywords
Parkinson, Telerehabilitation, Activities of daily living, Quality of life, Belance, Compliance
Medical subject headings
Parkinson Disease, Patient Compliance

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 patients will carry out motor, speech, and cognitive rehabilitation exercises using the VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy).

    The motor exercises will be performed using inertial sensors for the acquisition and processing of the movement performed by the patient. This data is shown to the patient with visual and auditory feedback in a serious games environment. The exercises will cover the rehabilitation of balance and lower limbs, for example Balance on one leg, March in place, Stand on tiptoe, Squat, etc. The physiotherapists involved in the study will define a protocol of exercises in TR mode customized according to the characteristics and needs of the patient. The exercises in the speech therapy and cognitive domains will be defined by the specialized staff based on the characteristics of the patient.

    The duration of the rehabilitation treatments is 9 hours per week.

  • Conventional rehabilitationOther

    The patients will carry out conventional rehabilitation treatments (including physiotherapy, occupational therapy, speech therapy, psychotherapy) without the use of any technological devices.

    The motor exercises will concern the rehabilitation of balance, trunk, and lower limbs and will be performed with a physiotherapist who will customize the treatment based on the characteristics and needs of the patient. The occupational therapy, speech therapy, psychotherapy treatments will be defined by the specialized staff based on the characteristics of the patient.

    The duration of the rehabilitation treatments is 9 hours per week.

Study groups in NCT05773885
Study groupRoleWhat they receive
Experimental Group (EG)ExperimentalThe Experimental Group (EG) will carry out 30 sessions (3-5 days/week, for 6-10 weeks) of motor, speech, and cognitive rehabilitation exercises using the VRRS Tablet home TR system (Khymeia srl, Noventa Padovana, Italy).
Receives: Device: VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)
Control Group (CG)Active comparatorThe Control Group (CG) will carry out 30 sessions (3-5 days/week, for 6-10 weeks) of conventional rehabilitation treatments (including physiotherapy, occupational therapy, speech therapy, psychotherapy) without the use of any technological devices.
Receives: Other: Conventional rehabilitation

What is being measured

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

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

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). A higher score indicated more severe symptoms of PD.

    Measured: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)

Secondary outcomes (10)

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

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. 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. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD.

    Measured: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)

  2. Change in the Parkinson's Disease Questionnaire-8 (PDQ-8)

    The Parkinson's Disease Questionaire-8 is a short-form version, derived from the Parkinson's Disease Questionaire-39. It is a self-administered questionnaire, used to measure the quality of life in People with PD. It consists of 8 questions regarding the subject's disease symptoms, each item ranging from 0 to 4, and the responses consist of 0=Never, 1=Occasionally, 2=Sometimes, 3=Often, and 4=Always or cannot do at all, total score ranging from 0 (never have problems/issues) to 32 (always have problems or cannot do at all).

    Measured: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)

  3. Change in the Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points.

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

  4. Change in the Lee Silverman Voice Treatment LOUD assessment (LSVT/LOUD)

    Maximum duration of sustained vocal phonation and variation of maximum fundamental frequency according to the LSVT/LOUD assessment protocol.

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

  5. 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)

  6. Change in the Timed Up and Go Dual task test (TUG-D)

    The TUG-D test is a dual-task dynamic measure for identifying individuals who are at risk for falls. It evaluates balance with a simultaneous cognitive and motor task. The cognitive task of the test is serial triple subtraction while the TUG test is a motor task. Balance performance will be recorded in seconds.

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

  7. 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)

  8. Change in the 10-meter WalkTest (10mWT)

    The 10mWT is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.

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

  9. Change in the New Freezing of Gait Questionnaire (NFOG-Q)

    The New Freezing of Gait Questionnaire (NFOG-Q) is a self-reported questionnaire consisting of 9 items that measure freezing of gait (FOG). The NFOG-Q is the renewed version of the FOG-Q, which originally consisted of 6 items. The total score ranges from 0 to 24, and higher scores denote more severe FOG.

    Measured: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)

  10. Change in the Activities-specific Balance Confidence scale (ABC)

    Activities-specific balance confidence (ABC) scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It consists of 16 questions gauging the individual's confidence while doing activities. The items are scored on a 0-100% scale. Items are totalled and then averaged. The higher the average score the higher the confidence with balance and the less likely risk there is for falling.

    Measured: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)

Timeline

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

  1. First posted17 Mar 2023
  2. Study start1 Sep 2022
  3. Primary completion30 Mar 2025
  4. Study completion14 Oct 2026

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
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05773885
Sponsor's protocol ID
RP 21/30
Acronym
TEMPO
Status last verified
Oct 2026
First submitted
3 Oct 2022
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) related to primary and secondary outcome measures, including assessment results and relevant demographic data, will be shared in compliance with ethical and legal requirements.

Publications

  • 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

  • Linares-Del Rey M, Vela-Desojo L, Cano-de la Cuerda R. Mobile phone applications in Parkinson's disease: A systematic review. Neurologia (Engl Ed). 2019 Jan-Feb;34(1):38-54. doi: 10.1016/j.nrl.2017.03.006. Epub 2017 May 23. English, Spanish.

    PubMed 28549757

  • Magrinelli F, Picelli A, Tocco P, Federico A, Roncari L, Smania N, Zanette G, Tamburin S. Pathophysiology of Motor Dysfunction in Parkinson's Disease as the Rationale for Drug Treatment and Rehabilitation. Parkinsons Dis. 2016;2016:9832839. doi: 10.1155/2016/9832839. Epub 2016 Jun 6.

    PubMed 27366343

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy) and Conventional rehabilitation in people with Parkinson's Disease, run by IRCCS San Raffaele Roma at 2 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 10 inclusion and 9 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - part II (time frame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)). 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 NCT05773885, which also lists 5 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 23 Oct 2026.

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