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

NCT04087031 | Recruiting

• 1 other identifier: INRCA_02_2019
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease; Frail Elderly; Robotic Devices in Rehabilitation

Keywords

Parkinson disease; robotics; elderly; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment

Secondary Outcomes (2)

• 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

• 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

Study Arms (3)

control arm

ACTIVE COMPARATOR

Ten traditional treatment sessions divided into 2 training sessions per week for 5 weeks

Other: control arm

virtual reality games arm

EXPERIMENTAL

Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks

Other: virtual reality games

robotic treadmill arm

EXPERIMENTAL

Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks

Other: robotic treadmill

Interventions

control arm OTHER

Each session will include 50 minutes of traditional physical rehabilitation therapy

control arm

virtual reality games OTHER

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.

virtual reality games arm

robotic treadmill OTHER

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

robotic treadmill arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead

Study Sites (2)

IRCCS INRCA Hospital

Ancona, 60131, Italy

RECRUITING

IRCCS INRCA Hospital

Fermo, Italy

RECRUITING

Related Publications (2)

• Maranesi E, Casoni E, Baldoni R, Barboni I, Rinaldi N, Tramontana B, Amabili G, Benadduci M, Barbarossa F, Luzi R, Di Donna V, Scendoni P, Pelliccioni G, Lattanzio F, Riccardi GR, Bevilacqua R. The Effect of Non-Immersive Virtual Reality Exergames versus Traditional Physiotherapy in Parkinson's Disease Older Patients: Preliminary Results from a Randomized-Controlled Trial. Int J Environ Res Public Health. 2022 Nov 10;19(22):14818. doi: 10.3390/ijerph192214818.

  PMID: 36429537 DERIVED

• 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.

  PMID: 32404132 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Roberta Bevilacqua

CONTACT

00390718004767; r.bevilacqua@inrca.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: December 3, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)