Clinical trial NCT04087031: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
Official title: Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Frail Elderly
Robotic Devices in Rehabilitation
Keywords: Parkinson disease
robotics
elderly
rehabilitation
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 195
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm
timeFrame: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
Secondary outcomes:
measure: difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm
timeFrame: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
measure: difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm
timeFrame: before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
city: Fermo
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
References:
citation: 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.