Parkinson DiseaseNCT04087031
Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
A study testing virtual reality games and robotic treadmill in people with Parkinson Disease and Frail Elderly, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.
Trial summary
The final goal of the present study is to propose a new approach in the Parkinson's Disease rehabilitation, focused on the use of robotic devices and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Parkinson Disease, Frail Elderly, Robotic Devices in Rehabilitation
- What is being tested?
- virtual reality games and robotic treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 2 sitesItaly
- Study dates
- 3 Dec 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hoen and Yahr scale: 1-3 stage
- FAC ≤ 2
- Ranking scale score ≤ 3
- Stability of drug treatment for at least 1 month
- Geriatric Depression Scale 5-items: negative
Who cannot join
- Concomitant participation in other studies
- Lack of written informed consent
- Clinical dementia rating (CDR) score ≥ 3
- History of syncopal episodes, epilepsy and vertigo not controlled pharmacologically
- Serious dysfunction of the autonomic system
- Severe behavioral syndromes not compensated by drugs
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- Concurrent neurological diseases
- Severe systemic diseases with life expectancy < 1 year
- Patients unable to follow up.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS INRCA Hospital
Ancona, 60131
Elvira Maranesi, e.maranesi@inrca.it
Giovanni R Riccardi, MD
- Recruiting
IRCCS INRCA Hospital
Fermo
Valentina Di Donna, v.didonna@inrca.it
Pietro Scendoni, MD
About this study
Official title: Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
The final goal of the present study is to propose a new approach in the Parkinson's Disease rehabilitation, focused on the use of robotic devices and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.
Read the detailed description
Parkinson's disease is one of the most frequent causes of disability among the elderly. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. The balance disorder is a symptom that involves the body axis; it is due to a reduction in the straightening reflexes, so the subject is not able to correct any imbalances. Balance disorders do not respond to dopaminergic therapy used in Parkinson's disease. Therefore, physiotherapy becomes an important intervention for the management of motor disorders. Originally, these rehabilitative approaches were based on empirical experiences, but several scientific evidence suggests that neuronal plasticity is exercise-dependent. In this context, robotic rehabilitation performs an important role because it allows to perform task-oriented exercises and to increase the number of repetitions and their intensity. This protocol study aims to evaluate an innovative rehabilitation treatment of the elderly patients with Parkinson's disease, designed to improve the gait and to reduce the risk of falling. The treatment involves the use of two robotic devices: Tymo system and Walker View.
This study is a single-blinded randomized controlled trial. 195 patients with PD will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation using Tyro system or Walker View in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. A 10 treatment sessions will be conducted, divided into 2 training sessions per week, for 5 weeks. The control group will perform traditional therapy sessions lasting 50 minutes. The technological intervention group will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system.
- Being tested
- control arm, virtual reality games, robotic treadmill
- Keywords
- Parkinson disease, robotics, elderly, rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control armOther
Each session will include 50 minutes of traditional physical rehabilitation therapy
virtual reality gamesOther
Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Tymo system (Tyromotion, Austria), a wireless static and dynamic platform, for evaluating and rehabilitating posture.
robotic treadmillOther
Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Walker View (TecnoBody, Italy) a treadmill equipped with a sensorized belt with eight load cells and a 3D camera
| Study group | Role | What they receive |
|---|---|---|
| control arm | Active comparator | Ten traditional treatment sessions divided into 2 training sessions per week for 5 weeks Receives: Other: control arm |
| virtual reality games arm | Experimental | Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks Receives: Other: virtual reality games |
| robotic treadmill arm | Experimental | Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks Receives: Other: robotic treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm
falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). POMA test has two subscales, Balance and Gait sections. Total score is obtained by adding the scores of the two subscales (balance + gait) . Total score < 19 high fall risk, total score 19-24 medium fall risk, total score 25-28 low fall risk.
Measured: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
Secondary outcomes (2)
difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm
gait performance will be assessed by walking speed through instrumental Gait Analysis
Measured: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm
fear of falling will be evaluated by the Falls Efficacy Scale - International (FES-I). Higher scores represent greater the fear of falling (ranging from 16 to 64)
Measured: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start3 Dec 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087031
- Sponsor's protocol ID
- INRCA_02_2019
- Status last verified
- Oct 2023
- First submitted
- 10 Sep 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maranesi E, Casoni E, Baldoni R, Barboni I, Rinaldi N, Tramontana B, Amabili G, Benadduci M, Barbarossa F, Luzi R, Di Donna V, Scendoni P, Pelliccioni G, Lattanzio F, Riccardi GR, Bevilacqua R. The Effect of Non-Immersive Virtual Reality Exergames versus Traditional Physiotherapy in Parkinson's Disease Older Patients: Preliminary Results from a Randomized-Controlled Trial. Int J Environ Res Public Health. 2022 Nov 10;19(22):14818. doi: 10.3390/ijerph192214818.
PubMed 36429537Bevilacqua R, Maranesi E, Di Rosa M, Luzi R, Casoni E, Rinaldi N, Baldoni R, Lattanzio F, Di Donna V, Pelliccioni G, Riccardi GR. Rehabilitation of older people with Parkinson's disease: an innovative protocol for RCT study to evaluate the potential of robotic-based technologies. BMC Neurol. 2020 May 13;20(1):186. doi: 10.1186/s12883-020-01759-4.
PubMed 32404132
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
- ClinicalTrials.gov ID
- NCT04087031
- Acronym / sponsor ID
- INRCA_02_2019
- Keywords
- Parkinson disease, robotics, elderly, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The final goal of the present study is to propose a new approach in the Parkinson's Disease rehabilitation, focused on the use of robotic devices and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.
Detailed description
Parkinson's disease is one of the most frequent causes of disability among the elderly. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. The balance disorder is a symptom that involves the body axis; it is due to a reduction in the straightening reflexes, so the subject is not able to correct any imbalances. Balance disorders do not respond to dopaminergic therapy used in Parkinson's disease. Therefore, physiotherapy becomes an important intervention for the management of motor disorders. Originally, these rehabilitative approaches were based on empirical experiences, but several scientific evidence suggests that neuronal plasticity is exercise-dependent. In this context, robotic rehabilitation performs an important role because it allows to perform task-oriented exercises and to increase the number of repetitions and their intensity. This protocol study aims to evaluate an innovative rehabilitation treatment of the elderly patients with Parkinson's disease, designed to improve the gait and to reduce the risk of falling. The treatment involves the use of two robotic devices: Tymo system and Walker View.
This study is a single-blinded randomized controlled trial. 195 patients with PD will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation using Tyro system or Walker View in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. A 10 treatment sessions will be conducted, divided into 2 training sessions per week, for 5 weeks. The control group will perform traditional therapy sessions lasting 50 minutes. The technological intervention group will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control arm | Active comparator | Other: control armTen traditional treatment sessions divided into 2 training sessions per week for 5 weeks |
| virtual reality games arm | Experimental | Other: virtual reality gamesTen technological treatment sessions divided into 2 training sessions per week for 5 weeks |
| robotic treadmill arm | Experimental | Other: robotic treadmillTen technological treatment sessions divided into 2 training sessions per week for 5 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Hoen and Yahr scale: 1-3 stage
- FAC ≤ 2
- Ranking scale score ≤ 3
- Stability of drug treatment for at least 1 month
- Geriatric Depression Scale 5-items: negative
Key exclusion criteria (9 listed)
- Concomitant participation in other studies
- Lack of written informed consent
- Clinical dementia rating (CDR) score ≥ 3
- History of syncopal episodes, epilepsy and vertigo not controlled pharmacologically
- Serious dysfunction of the autonomic system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| control armEach session will include 50 minutes of traditional physical rehabilitation therapy | Other | control arm |
| virtual reality gamesEach session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Tymo system (Tyromotion, Austria), a wireless static and dynamic platform, for evaluating and rehabilitating posture. | Other | virtual reality games arm |
| robotic treadmillEach session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Walker View (TecnoBody, Italy) a treadmill equipped with a sensorized belt with eight load cells and a 3D camera | Other | robotic treadmill arm |
Primary outcome
difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm
Time frame: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). POMA test has two subscales, Balance and Gait sections. Total score is obtained by adding the scores of the two subscales (balance + gait) . Total score < 19 high fall risk, total score 19-24 medium fall risk, total score 25-28 low fall risk.
2 secondary outcomes
difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm
Time frame: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm
Time frame: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 36429537Maranesi E, Casoni E, Baldoni R, Barboni I, Rinaldi N, Tramontana B, Amabili G, Benadduci M, Barbarossa F, Luzi R, Di Donna V, Scendoni P, Pelliccioni G, Lattanzio F, Riccardi GR, Bevilacqua R. The Effect of Non-Immersive Virtual Reality Exergames versus Traditional Physiotherapy in Parkinson's Disease Older Patients: Preliminary Results from a Randomized-Controlled Trial. Int J Environ Res Public Health. 2022 Nov 10;19(22):14818. doi: 10.3390/ijerph192214818.
- Derived from this study: PubMed 32404132Bevilacqua R, Maranesi E, Di Rosa M, Luzi R, Casoni E, Rinaldi N, Baldoni R, Lattanzio F, Di Donna V, Pelliccioni G, Riccardi GR. Rehabilitation of older people with Parkinson's disease: an innovative protocol for RCT study to evaluate the potential of robotic-based technologies. BMC Neurol. 2020 May 13;20(1):186. doi: 10.1186/s12883-020-01759-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality games and robotic treadmill in people with Parkinson Disease and Frail Elderly, run by Istituto Nazionale di Ricovero e Cura per Anziani 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 5 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: looking for participants now, as of the sponsor's last update on 23 Oct 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberta Bevilacqua (00390718004767, r.bevilacqua@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm (time frame: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment). 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 NCT04087031, which also lists 2 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 2023.