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NCT Number: NCT06730074

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

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.

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Key information

Conditions

Parkinson Disease, Idiopathic Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. level of engagement

    Time frame: 2 Mon

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

Secondary outcomes

  1. improvement in UPDRS

    Time frame: 4 Mon

    We will perform post-intervention assessments which include motor UPDRS (Unified Parkinson Disease Rating Scale)

  2. improvement in fine motor coordination

    Time frame: 4 Mon

    We will perform post-intervention assessments which include Box and Blocks Test for fine motor coordination.

  3. improvement in CTT (Color Trail Test)

    Time frame: 4 Mon

    We will perform post-intervention assessments which include CTT (Color Trail Test) for executive functions.

  4. Testing the usability of use of the system

    Time frame: 4 Mon

    We will perform post-intervention assessments which include System Usability Scale (SUS).

  5. Measuring the motivation to use the system

    Time frame: 4 Mon

    We will perform post-intervention assessments which include the Intrinsic Motivation Inventory (IMI).

Study contacts

Contact information is provided by the study sponsor or research team.

Dori Katz, Medical Doctor

CONTACT

[email protected]

+972 52 268 9046

Ilanit Baum Cohen, Msc. OT

CONTACT

[email protected]

+972 52 8807 503

Sponsors and collaborators

Lead sponsor

Adi Negev-Nahalat Eran

Other

Registry information

Acronym: PD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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