A Novel Robotic System for Motor-cognitive Exercise for Patients With Parkinson's Disease

NCT06730074 | Recruiting DMC

• 1 other identifier: 0005-NGV-24
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to test a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD). This pilot experiment will involve the collection of both subjective user evaluation measures and objective motor and cognitive measures.

Conditions

Parkinson Disease, Idiopathic

Keywords

Parkinson-disease; SAR; Rehabilitation; Motor-Cognitive; PD

Outcome Measures

Primary Outcomes (1)

• level of engagement

  We will ask participants to rate their perceived level of engagement with the platform.

  2 Mon

Secondary Outcomes (5)

• improvement in UPDRS

  4 Mon

• improvement in fine motor coordination

  4 Mon

• improvement in CTT (Color Trail Test)

  4 Mon

• Testing the usability of use of the system

  4 Mon

• Measuring the motivation to use the system

  4 Mon

Study Arms (1)

Gamified rehabilitation system involving robot for individuals with Parkinson's

EXPERIMENTAL

We will run a robotic exercise game with 15 PD patients who will use the system in a sitting position. Each patient will use the system 5 times, each time for 30 min. Principles of effective rehabilitation practice such as repetitive practice, goal-oriented practice, variable difficulty, rhythmic cueing, and social interaction are implemented in our design

Device: Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD)

Interventions

Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD) DEVICE

This is the first socially assistive robotic platform developed specifically for people with PD. If successful, this platform could be incorporated into the clinical toolbox at Adi Negev and other centres.

Gamified rehabilitation system involving robot for individuals with Parkinson's

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing the informed consent form
• Men and women in ages 50-75
• Hebrew speakers
• Have Idiopathic Parkinson's disease
• Hoehn and Yahr 3 and below
• Moca test 23 and above

You may not qualify if:

• Patients with Parkinson's plus syndromes
• PD patients who suffer from unrelated neurological symptoms.
• Orthopedic problems of the upper limb
• Recent surgery conducted on the upper limb
• Uncorrected vision problems
• Uncorrected severe hearing loss

Sponsors & Collaborators

• Adi Negev-Nahalat Eran: lead

Study Sites (1)

Adi Negev

Ofakim, South, Israel

RECRUITING

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

Dori Katz, Medical Doctor

CONTACT

+972 52 268 9046; dorik@adi-il.org

Ilanit Baum Cohen, Msc. OT

CONTACT

+972 52 8807 503; ilanit.nit@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist

Model Details: The study will be conducted with 15 PD patients, aged 50-75

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: December 12, 2024
• Study Start: December 12, 2024
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

IL (1)