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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

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

Treatments: Other: virtual reality games; Other: robotic treadmill; Other: control arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04087031

INRCA_02_2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

195 participants in 3 patient groups

control arm

Active Comparator group

Description:

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

Treatment:

Other: control arm

virtual reality games arm

Experimental group

Description:

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

Treatment:

Other: virtual reality games

robotic treadmill arm

Experimental group

Description:

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

Treatment:

Other: robotic treadmill