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

Not Applicable

Recruiting

• Conditions: Parkinson Disease; Frail Elderly; Robotic Devices in Rehabilitation
• Interventions: Other: virtual reality games; Other: robotic treadmill; Other: control arm

• Registration Number: NCT04087031
• Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani

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.

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Study Start: 2019-12-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 195

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
virtual reality games arm	virtual reality games	Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks
robotic treadmill arm	robotic treadmill	Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks
control arm	control arm	Ten traditional treatment sessions divided into 2 training sessions per week for 5 weeks

Primary Outcome Measures

Name	Time	Method
difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm	before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment	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.

Secondary Outcome Measures

Name	Time	Method
difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm	before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment	gait performance will be assessed by walking speed through instrumental Gait Analysis
difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm	before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment	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)

Trial Locations

Locations (1)

IRCCS INRCA Hospital; 🇮🇹 Fermo, Italy