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

Not Applicable

Recruiting

• Conditions: Parkinson Disease, Idiopathic

• Registration Number: NCT06730074
• Lead Sponsor: Adi Negev-Nahalat Eran

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.

Study Timeline

• Study First Submitted: 2024-10-24
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-11
• Study Start: 2024-12-12
• Study First Posted: 2024-12-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-03
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
level of engagement	2 Mon	We will ask participants to rate their perceived level of engagement with the platform.

Secondary Outcome Measures

Name	Time	Method
improvement in UPDRS	4 Mon	We will perform post-intervention assessments which include motor UPDRS (Unified Parkinson Disease Rating Scale)
improvement in fine motor coordination	4 Mon	We will perform post-intervention assessments which include Box and Blocks Test for fine motor coordination.
improvement in CTT (Color Trail Test)	4 Mon	We will perform post-intervention assessments which include CTT (Color Trail Test) for executive functions.
Testing the usability of use of the system	4 Mon	We will perform post-intervention assessments which include System Usability Scale (SUS).
Measuring the motivation to use the system	4 Mon	We will perform post-intervention assessments which include the Intrinsic Motivation Inventory (IMI).

Trial Locations

Locations (1)

Adi Negev; 🇮🇱 Ofakim, South, Israel