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

December 12, 2024 updated by: Ilanit Baum-Cohen, Adi Negev-Nahalat Eran
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dori Katz, Medical Doctor
  • Phone Number: +972 52 268 9046
  • Email: dorik@adi-il.org

Study Contact Backup

Study Locations

  • Israel
    • South
      • Ofakim, South, Israel
        • Recruiting
        • Adi Negev
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ilanit Baum-Cohen, OT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gamified rehabilitation system involving robot for individuals with Parkinson's
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of engagement
Time Frame: 2 Mon
We will ask participants to rate their perceived level of engagement with the platform.
2 Mon

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement in UPDRS
Time Frame: 4 Mon
We will perform post-intervention assessments which include motor UPDRS (Unified Parkinson Disease Rating Scale)
4 Mon
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.
4 Mon
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 Mon
Testing the usability of use of the system
Time Frame: 4 Mon
We will perform post-intervention assessments which include System Usability Scale (SUS).
4 Mon
Measuring the motivation to use the system
Time Frame: 4 Mon
We will perform post-intervention assessments which include the Intrinsic Motivation Inventory (IMI).
4 Mon

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adi Negev-Nahalat Eran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

December 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0005-NGV-24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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