A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders.
New rehab tech for neurological disorders: safety and effectiveness study
Plain English Summary
A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders. is a Not Applicable clinical trial sponsored by University of Pavia studying Neurological Disorders, Health Adult Subjects. This study tests a new 3D balance platform designed to help people with neurological conditions improve their balance, coordination, and brain function. It's for adults with conditions like stroke, Parkinson's disease, ALS, or mild cognitive impairment, and also for healthy volunteers. Participants will use the new balance platform for rehabilitation exercises, with some receiving it alongside standard care and others receiving standard care alone. Alternatives include traditional physical therapy and other existing rehabilitation programs. The trial aims to enroll 60 participants.
Official Summary
This multicenter interventional study aims to evaluate a three-degrees-of-freedom dynamic platform (3DoF Platform) designed to support rehabilitation of balance, proprioception, and motor and cognitive functions in patients with neurological disorders. The device integrates a mobile platform capable of roll, pitch, and vertical translation movements, a markerless motion-capture system, and an interactive environment delivered through a monitor or virtual reality headset. Compared with conventional rehabilitation systems, it offers an additional vertical degree of freedom and increased proprioceptive stimulation, with the ability to customize exercises according to individual patient capabilities. The clinical conditions under investigation include Parkinson's disease, post-stroke motor impairment, amyotrophic lateral sclerosis, and mild cognitive impairment, all of which are associated with deficits in balance and proprioception. The novelty of this study lies in the combined use of the 3DoF platform, the markerless acquisition system, and exergames integrated with a mathematical model that adapts the platform's dynamic response in real time. The primary objective is to assess the usability, feasibility, and safety of the device. Secondary objectives include evaluating the impact of the intervention on balance, motor performance, cognitive functions, stress, fatigue, and quality of life, as well as comparing conventional rehabilitation with and without the addition of the device. The study involves 45 patients and 15 healthy volunteers and is structured into an initial phase of testing on healthy subjects and a subsequent randomized two-arm treatment phase for patients.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18-80 with a confirmed diagnosis of stroke, Parkinson's disease, ALS, or mild cognitive impairment can join. You cannot join if you have severe psychiatric or cognitive issues, cannot stand on the platform, weigh over 100kg, or have unstable health conditions. Healthy volunteers aged 18-65, including rehabilitation staff, can also participate if they are in good health. Participants must be able to understand and follow study instructions and give their consent. This trial is studying Neurological Disorders, Health Adult Subjects, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes will show if the new balance system is safe and easy for patients and staff to use, and if it causes any anxiety or affects their perception of care. The specific primary outcome measures are: Incidence of Adverse Events (From the first session to the end of the intervention, up to 4 weeks); Evaluation of System Usability Scale (SUS) (Session 12 (final evaluation, Week 4).); Evaluation of Quality of Care Through the Patient's Eyes (QUEST) 2.0 (Session 12 (final evaluation, Week 4).); Evaluation of Technology Assisted Rehabilitation Patient Perception Questionnaire (Session 12 (final evaluation, Week 4).); Change from baseline in State-Trait Anxiety Inventory (Baseline (Session 1) and Session 12 (final evaluation, Week 4)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it explores a novel rehabilitation technology that could offer a more advanced and personalized approach to improving balance and motor function for individuals with debilit This research targets Neurological Disorders, Health Adult Subjects, where improved treatment options are needed.
Investor Insight
This study investigates a potentially innovative rehabilitation device, targeting a significant patient population with neurological disorders, suggesting a market opportunity for advanced therapeutic
Is This Trial Right for Me?
Ask your doctor if this new balance technology is suitable for your specific condition and if it's different from your current therapy. Participation involves using a special 3D balance platform for exercises, potentially with virtual reality, for about 12 sessions over 4 weeks. You may be asked to complete questionnaires about your experience, balance, and overall well-being. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 60 participants
Interventions
- DEVICE: 3DOF balance board robotic platform group — The 3DOF balance platform system distinguishes itself by providing controlled perturbations across three degrees of freedom: roll, pitch, and vertical translation (heave), the latter being a unique feature for enhancing proprioceptive stimulation. The platform integrates a markerless motion capture system that tracks the patient's Center of Mass in real-time without wearable sensors.
- OTHER: Conventional Rehabilitation — Traditional rehabilitative treatment delivered according to usual clinical practice at the participating centers. Participants undergo 12 sessions of at least 30 minutes each, three times per week.
Primary Outcomes
- Incidence of Adverse Events (From the first session to the end of the intervention, up to 4 weeks)
- Evaluation of System Usability Scale (SUS) (Session 12 (final evaluation, Week 4).)
- Evaluation of Quality of Care Through the Patient's Eyes (QUEST) 2.0 (Session 12 (final evaluation, Week 4).)
- Evaluation of Technology Assisted Rehabilitation Patient Perception Questionnaire (Session 12 (final evaluation, Week 4).)
- Change from baseline in State-Trait Anxiety Inventory (Baseline (Session 1) and Session 12 (final evaluation, Week 4))
Secondary Outcomes
- Change from baseline in Berg Balance Scale (Baseline (Session 1) and Session 12 (final evaluation, Week 4))
- Change From Baseline in Timed Up and Go (TUG) (Baseline (Session 1) and Session 12 (final evaluation, Week 4))
- Change From Baseline in 6-Minute Walk Test (6MWT) (Baseline (Session 1) and Session 12 (final evaluation, Week 4))
- Change From Baseline in 10-Meter Walk Test (10MWT) (Baseline (Session 1) and Session 12 (final evaluation, Week 4))
- Change From Baseline in Fugl-Meyer Assessment Score (Baseline (Session 1) and Session 12 (final evaluation, Week 4))
Frequently Asked Questions
What is clinical trial NCT07502937?
NCT07502937 is a Not Applicable INTERVENTIONAL study titled "A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders.." It is currently not yet recruiting and is sponsored by University of Pavia. The trial targets enrollment of 60 participants.
What conditions does NCT07502937 study?
This trial investigates treatments for Neurological Disorders, Health Adult Subjects. The primary condition under study is Neurological Disorders.
What treatments are being tested in NCT07502937?
The interventions being studied include: 3DOF balance board robotic platform group (DEVICE), Conventional Rehabilitation (OTHER). The 3DOF balance platform system distinguishes itself by providing controlled perturbations across three degrees of freedom: roll, pitch, and vertical translation (heave), the latter being a unique feature for enhancing proprioceptive stimulation. The platform integrates a markerless motion capture system that tracks the patient's Center of Mass in real-time without wearable sensors.
What does Not Applicable mean for NCT07502937?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07502937?
This trial is currently "Not Yet Recruiting." It started on 2026-04. The estimated completion date is 2026-11.
Who is sponsoring NCT07502937?
NCT07502937 is sponsored by University of Pavia. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07502937?
The trial aims to enroll 60 participants. The trial has not yet started recruiting.
How is NCT07502937 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07502937?
The primary outcome measures are: Incidence of Adverse Events (From the first session to the end of the intervention, up to 4 weeks); Evaluation of System Usability Scale (SUS) (Session 12 (final evaluation, Week 4).); Evaluation of Quality of Care Through the Patient's Eyes (QUEST) 2.0 (Session 12 (final evaluation, Week 4).); Evaluation of Technology Assisted Rehabilitation Patient Perception Questionnaire (Session 12 (final evaluation, Week 4).); Change from baseline in State-Trait Anxiety Inventory (Baseline (Session 1) and Session 12 (final evaluation, Week 4)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07502937?
The official record for NCT07502937 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07502937. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07502937 testing in simple terms?
This study tests a new 3D balance platform designed to help people with neurological conditions improve their balance, coordination, and brain function. It's for adults with conditions like stroke, Parkinson's disease, ALS, or mild cognitive impairment, and also for healthy volunteers.
Why is this trial significant?
This trial matters because it explores a novel rehabilitation technology that could offer a more advanced and personalized approach to improving balance and motor function for individuals with debilit
What are the potential risks of participating in NCT07502937?
The main risks are related to the use of the balance platform, such as falls or discomfort, though the study prioritizes safety. Potential side effects could include temporary dizziness, fatigue, or anxiety related to the new technology or exercises. The study will monitor for any adverse events to ensure participant well-being throughout the trial. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07502937?
Ask your doctor if this new balance technology is suitable for your specific condition and if it's different from your current therapy. Participation involves using a special 3D balance platform for exercises, potentially with virtual reality, for about 12 sessions over 4 weeks. You may be asked to complete questionnaires about your experience, balance, and overall well-being. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07502937 signal from an investment perspective?
This study investigates a potentially innovative rehabilitation device, targeting a significant patient population with neurological disorders, suggesting a market opportunity for advanced therapeutic This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will use the new balance platform for rehabilitation exercises, with some receiving it alongside standard care and others receiving standard care alone. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.