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Recruiting NCT06730074

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

No phase Interventional Parkinson Disease, Idiopathic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD).
Who it may be relevant to
Registry conditions: Parkinson Disease, Idiopathic. Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • level of engagement [Time frame: 2 Mon]
Secondary outcome measures (5)
  • improvement in UPDRS [Time frame: 4 Mon]
  • improvement in fine motor coordination [Time frame: 4 Mon]
  • improvement in CTT (Color Trail Test) [Time frame: 4 Mon]
  • Testing the usability of use of the system [Time frame: 4 Mon]
  • Measuring the motivation to use the system [Time frame: 4 Mon]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Israel · 1 center
  • Adi Negev — Ofakim

Identifiers

NCT: NCT06730074 · 0005-NGV-24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗