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

October 20, 2023 updated by: Istituto Nazionale di Ricovero e Cura per Anziani

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy, 60131
        • Recruiting
        • IRCCS INRCA Hospital
        • Contact:
        • Principal Investigator:
          • Giovanni R Riccardi, MD
      • Fermo, Italy
        • Recruiting
        • IRCCS INRCA Hospital
        • Contact:
        • Principal Investigator:
          • Pietro Scendoni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control arm
Ten traditional treatment sessions divided into 2 training sessions per week for 5 weeks
Other: control arm
Each session will include 50 minutes of traditional physical rehabilitation therapy
Experimental: virtual reality games arm
Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks
Other: 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.
Experimental: robotic treadmill arm
Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm
Time Frame: 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.
before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm
Time Frame: 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
before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm
Time Frame: 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)
before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 10, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INRCA_02_2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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