Clinical trial NCT06730074: A Novel Robotic System for Motor-cognitive Exercise for Patients With Parkinson's Disease
Official title: A Novel Robotic System for Motor-cognitive Exercise for Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease, Idiopathic
Keywords: Parkinson-disease
SAR
Rehabilitation
Motor-Cognitive
PD
Lead sponsor: Adi Negev-Nahalat Eran
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will be conducted with 15 PD patients, aged 50-75
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: level of engagement
timeFrame: 2 Mon
Secondary outcomes:
measure: improvement in UPDRS
timeFrame: 4 Mon
measure: improvement in fine motor coordination
timeFrame: 4 Mon
measure: improvement in CTT (Color Trail Test)
timeFrame: 4 Mon
measure: Testing the usability of use of the system
timeFrame: 4 Mon
measure: Measuring the motivation to use the system
timeFrame: 4 Mon
Other outcomes:
Locations:
city: Ofakim
country: Israel
facility: Adi Negev
state: South
Study officials:
References: