Recruiting · registry status

Testing robotic rehabilitation and its longer-term effects

Researchers investigate robot-assisted rehabilitation for older people with Parkinson’s and follow participants after treatment to assess lasting changes.

Testing a treatment or activity · Study reference: NCT04087031

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Looking for volunteers

Start (reported actual date): 2019-12-03
Main measurements finished (planned): 2026-12-31
Study finished (planned): 2026-12-31

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded

2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

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. ↗
Registry derived research reference

Bevilacqua 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. ↗
Registry derived research reference

Who can join?

Age 65 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Concurrent neurological diseases * Severe systemic diseases with life expectancy \< 1 year * Patients unable to follow up.

Full study name & original research details

Official study title

Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation

Short title used by the registry

Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation

Original description

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.

Further description from the registry

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.

Conditions reported: Parkinson Disease; Frail Elderly; Robotic Devices in Rehabilitation

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

ClinicalTrials.gov · NCT04087031 ↗ — RECRUITING; checked 2026-10-13
ClinicalTrials.gov · NCT04087031 ↗ — Recruiting; WHO ICTRP processed 2023-10-30; checked 2026-10-13

Study type: Interventional
Interventions: control arm; virtual reality games; robotic treadmill
Phases: NA
Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Start date reported by registry: 2019-12-03 (actual)

Registry updated: 2023-10-23 · Status last verified by the registry submitter: 2023-10

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Roberta Bevilacqua · 00390718004767 · r.bevilacqua@inrca.it

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

IRCCS INRCA Hospital

Ancona, Italy

Recruiting

Elvira Maranesi · e.maranesi@inrca.it

Giovanni R Riccardi, MD

IRCCS INRCA Hospital

Fermo, Italy

Recruiting

Valentina Di Donna · v.didonna@inrca.it

Pietro Scendoni, MD

Facility not reported

Italy

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.