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

Last updated: October 20, 2023
Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

control arm

virtual reality games

robotic treadmill

Clinical Study ID

NCT04087031
INRCA_02_2019
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 195
Treatment Group(s): 3
Primary Treatment: control arm
Phase:
Study Start date:
December 03, 2019
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • IRCCS INRCA Hospital

    Ancona, 60131
    Italy

    Active - Recruiting

  • IRCCS INRCA Hospital

    Fermo,
    Italy

    Active - Recruiting

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