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

NCT ID: NCT04087031

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-03
• Study Completion Date: 2026-12-31

Brief 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.

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.

Conditions

Parkinson Disease; Frail Elderly; Robotic Devices in Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control arm

Ten traditional treatment sessions divided into 2 training sessions per week for 5 weeks

Group Type: ACTIVE_COMPARATOR

control arm

Intervention Type: OTHER

Each session will include 50 minutes of traditional physical rehabilitation therapy

virtual reality games arm

Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks

Group Type: EXPERIMENTAL

virtual reality games

Intervention Type: OTHER

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 treadmill arm

Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks

Group Type: EXPERIMENTAL

robotic treadmill

Intervention Type: OTHER

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

Interventions

control arm

Each session will include 50 minutes of traditional physical rehabilitation therapy

Intervention Type: OTHER

virtual reality games

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.

Intervention Type: OTHER

robotic treadmill

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS INRCA Hospital

Ancona, , Italy

Site Status: RECRUITING

IRCCS INRCA Hospital

Fermo, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberta Bevilacqua

Role: CONTACT

r.bevilacqua@inrca.it

00390718004767

Facility Contacts

Elvira Maranesi

Role: primary

e.maranesi@inrca.it

Valentina Di Donna

Role: primary

v.didonna@inrca.it

References

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.

Reference Type: DERIVED

PMID: 36429537 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32404132 (View on PubMed)

Other Identifiers

INRCA_02_2019

Identifier Type: -

Identifier Source: org_study_id