Parkinson Disease, IdiopathicPDNCT06730074
A Novel Robotic System for Motor-cognitive Exercise for Patients With Parkinson's Disease
A study testing Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD) in people with Parkinson Disease, Idiopathic, run by Adi Negev-Nahalat Eran at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson Disease, Idiopathic
- What is being tested?
- Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Dec 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Adi Negev
Ofakim, South
Dori Katz, DR, +972522689046, ilanit.nit@gmail.com
Neta Kislev, OT, +972547918662, netakislev.ot@gmail.com
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Idiopathic
- Being tested
- Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD)
- Keywords
- Parkinson-disease, SAR, Rehabilitation, Motor-Cognitive, PD
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Gamified rehabilitation system involving robot for individuals with Parkinson's | Experimental | 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 Receives: Device: Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of engagement
We will ask participants to rate their perceived level of engagement with the platform.
Measured: 2 Mon
Secondary outcomes (5)
improvement in UPDRS
We will perform post-intervention assessments which include motor UPDRS (Unified Parkinson Disease Rating Scale)
Measured: 4 Mon
improvement in fine motor coordination
We will perform post-intervention assessments which include Box and Blocks Test for fine motor coordination.
Measured: 4 Mon
improvement in CTT (Color Trail Test)
We will perform post-intervention assessments which include CTT (Color Trail Test) for executive functions.
Measured: 4 Mon
Testing the usability of use of the system
We will perform post-intervention assessments which include System Usability Scale (SUS).
Measured: 4 Mon
Measuring the motivation to use the system
We will perform post-intervention assessments which include the Intrinsic Motivation Inventory (IMI).
Measured: 4 Mon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start12 Dec 2024
- Primary completionMar 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will be conducted with 15 PD patients, aged 50-75
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adi Negev-Nahalat Eran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilanit Baum-Cohen, Adi Negev-Nahalat Eran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730074
- Sponsor's protocol ID
- 0005-NGV-24
- Acronym
- PD
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Robotic System for Motor-cognitive Exercise for Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06730074
- Acronym / sponsor ID
- PD / 0005-NGV-24
- Conditions
- Parkinson Disease, Idiopathic
- Keywords
- Parkinson-disease, SAR, Rehabilitation, Motor-Cognitive, PD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Adi Negev-Nahalat EranUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be conducted with 15 PD patients, aged 50-75
| Arm | Type | Receives |
|---|---|---|
| Gamified rehabilitation system involving robot for individuals with Parkinson's | Experimental | Device: Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD)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 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Gamified rehabilitation system involving robot for individuals with Parkinson's |
Primary outcome
level of engagement
Time frame: 2 Mon
We will ask participants to rate their perceived level of engagement with the platform.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD) in people with Parkinson Disease, Idiopathic, run by Adi Negev-Nahalat Eran at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dori Katz, Medical Doctor (+972 52 268 9046, dorik@adi-il.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of engagement (time frame: 2 Mon). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.