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

Adi Negev-Nahalat Eran

Status: Enrolling

Conditions: Parkinson Disease, Idiopathic

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06730074

0005-NGV-24

Details and patient eligibility

About

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.

Full description

Participants & Protocol:

Recruitment: Advertising ads in movement disorders units in hospitals and medical centers in the south, as well as through the help of the Parkinson's Association.

The study will be conducted with 15 PD patients, aged 50-75, at the Adi Negev Clinic. Each patient will use the robotic system five times, with each session lasting 30 minutes. The intervention plan incorporates principles of effective rehabilitation practice, including repeated practice, goal-oriented practice, variable difficulty, rhythmic cueing, and social interaction. Before the research begins, participants will sign an informed consent form.

Baseline and Pre-Post Tests:

Assessments including the MoCA, demographic data, clinical data, Color Trails Test (CTT), motor UPDRS, Box & Blocks Test, and Cognitive Reserve Index Questionnaire (CRIq) will be collected before the first session by an occupational or physical therapist. After the fifth session, post-intervention assessments will include motor UPDRS, Box & Blocks Test, CTT, System Usability Scale (SUS), Intrinsic Motivation Inventory (IMI), and a satisfaction questionnaire.

Hypothesis:

It is hypothesized that motor and cognitive training using the robots will improve the patients' clinical symptoms, as evidenced by pre-post test results.

Novelty & Impact:

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. Additionally, this study will be the first to use the Cognitive Reserve Index Questionnaire (CRIq) in Hebrew for people with PD. The potential impact of this project is twofold: testing a new rehabilitation tool and a screening tool for PD patients.

Enrollment: 15 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Gamified rehabilitation system involving robot for individuals with Parkinson's

Experimental group

Description:

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

Treatment:

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