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Clinical Trials/NCT06730074
NCT06730074
Recruiting
Not Applicable

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

Adi Negev-Nahalat Eran1 site in 1 country15 target enrollmentDecember 12, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease, Idiopathic
Sponsor
Adi Negev-Nahalat Eran
Enrollment
15
Locations
1
Primary Endpoint
level of engagement
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2024
End Date
August 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Adi Negev-Nahalat Eran
Responsible Party
Principal Investigator
Principal Investigator

Ilanit Baum-Cohen

Occupational Therapist

Adi Negev-Nahalat Eran

Eligibility Criteria

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

Outcomes

Primary Outcomes

level of engagement

Time Frame: 2 Mon

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

Secondary Outcomes

  • 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 Sites (1)

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