Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
Primary Purpose
Parkinson Disease, Frail Elderly, Robotic Devices in Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
control arm
virtual reality games
robotic treadmill
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, robotics, elderly, rehabilitation
Eligibility 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.
Sites / Locations
- IRCCS INRCA HospitalRecruiting
- IRCCS INRCA HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
control arm
virtual reality games arm
robotic treadmill arm
Arm Description
Ten traditional treatment sessions divided into 2 training sessions per week for 5 weeks
Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks
Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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)
Full Information
NCT ID
NCT04087031
First Posted
September 10, 2019
Last Updated
October 20, 2023
Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
1. Study Identification
Unique Protocol Identification Number
NCT04087031
Brief Title
Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
Official Title
Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Frail Elderly, Robotic Devices in Rehabilitation
Keywords
Parkinson disease, robotics, elderly, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
195 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control arm
Arm Type
Active Comparator
Arm Description
Ten traditional treatment sessions divided into 2 training sessions per week for 5 weeks
Arm Title
virtual reality games arm
Arm Type
Experimental
Arm Description
Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks
Arm Title
robotic treadmill arm
Arm Type
Experimental
Arm Description
Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks
Intervention Type
Other
Intervention Name(s)
control arm
Intervention Description
Each session will include 50 minutes of traditional physical rehabilitation therapy
Intervention Type
Other
Intervention Name(s)
virtual reality games
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
robotic treadmill
Intervention Description
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 Measure Information:
Title
difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm
Description
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.
Time Frame
before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
Secondary Outcome Measure Information:
Title
difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm
Description
gait performance will be assessed by walking speed through instrumental Gait Analysis
Time Frame
before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
Title
difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm
Description
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)
Time Frame
before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Bevilacqua
Phone
00390718004767
Email
r.bevilacqua@inrca.it
Facility Information:
Facility Name
IRCCS INRCA Hospital
City
Ancona
ZIP/Postal Code
60131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elvira Maranesi
Email
e.maranesi@inrca.it
First Name & Middle Initial & Last Name & Degree
Giovanni R Riccardi, MD
Facility Name
IRCCS INRCA Hospital
City
Fermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Di Donna
Email
v.didonna@inrca.it
First Name & Middle Initial & Last Name & Degree
Pietro Scendoni, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32404132
Citation
Bevilacqua R, Maranesi E, Di Rosa M, Luzi R, Casoni E, Rinaldi N, Baldoni R, Lattanzio F, Di Donna V, Pelliccioni G, Riccardi GR. Rehabilitation of older people with Parkinson's disease: an innovative protocol for RCT study to evaluate the potential of robotic-based technologies. BMC Neurol. 2020 May 13;20(1):186. doi: 10.1186/s12883-020-01759-4.
Results Reference
derived
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Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
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