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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04087031
• Other study ID #: INRCA_02_2019
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: Roberta Bevilacqua
• Phone: 00390718004767
• Email: r.bevilacqua[@]inrca.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly
• Parkinson Disease
• Robotic Devices in Rehabilitation

Intervention

Other:
• control arm
Each session will include 50 minutes of traditional physical rehabilitation therapy
• 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.
• 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

Locations

Country	Name	City	State
Italy	IRCCS INRCA Hospital	Ancona
Italy	IRCCS INRCA Hospital	Fermo

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
Secondary	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	before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
Secondary	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)	before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment