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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04087031
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Frail Elderly Robotic Devices in Rehabilitation Other: control arm Other: virtual reality games Other: robotic treadmill Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087031


Contacts
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Contact: Roberta Bevilacqua 00390718004767 r.bevilacqua@inrca.it

Locations
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Italy
IRCCS INRCA Hospital Recruiting
Ancona, Italy, 60131
Contact: Elvira Maranesi       e.maranesi@inrca.it   
Principal Investigator: Giovanni R Riccardi, MD         
IRCCS INRCA Hospital Recruiting
Fermo, Italy
Contact: Valentina Di Donna       v.didonna@inrca.it   
Principal Investigator: Pietro Scendoni, MD         
Sponsors and Collaborators
Istituto Nazionale di Ricovero e Cura per Anziani
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Istituto Nazionale di Ricovero e Cura per Anziani
ClinicalTrials.gov Identifier: NCT04087031    
Other Study ID Numbers: INRCA_02_2019
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Nazionale di Ricovero e Cura per Anziani:
Parkinson disease
robotics
elderly
rehabilitation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases