Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Istituti Clinici Scientifici Maugeri SpA | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Neurological conditions such as stroke, Parkinson's disease (PD), amyotrophic lateral sclerosis (ALS) and mild cognitive impairment (MCI) frequently impair balance and proprioception through combined central and peripheral mechanisms. Alterations in muscle spindles, joint mechanoreceptors and cortical grey matter volumes compromise postural control, coordination and the ability to adapt movements without continuous visual feedback. These deficits lead to gait instability, increased risk of falls, traumatic injuries, loss of independence and high healthcare utilisation, especially in ageing populations where multimorbidity and frailty are prevalent. In this context, interventions that can effectively target balance and proprioceptive dysfunction are highly relevant to current healthcare challenges, which include reducing fall-related hospitalisations, supporting safe community living and improving quality of life in people with chronic neurological disease. Conventional neurorehabilitation relies on therapist-guided balance exercises, overground or treadmill gait training and task-oriented activities. These approaches are effective but often limited by the intensity and variability that can be delivered in routine practice, and by the scarcity of objective kinematic data to guide personalised progression. Robotic and moving-platform systems used in research settings have shown that perturbation-based and task-specific balance training can improve postural responses, gait and falls risk in several neurological populations, yet many commercial devices offer only two degrees of freedom and restricted ranges of motion. Evidence on the integration of immersive exergames and virtual reality (VR) into balance training suggests benefits in engagement and cognitive-motor stimulation, but existing technologies are frequently non-adaptive, do not exploit full-body motion capture, and have been evaluated mainly in small, single-pathology cohorts. There remains a gap for multifunctional systems that combine multi-axis mechanical perturbations, markerless motion analysis and immersive exergames, and that are systematically tested in diverse neurological conditions within real clinical workflows. The 3DoF Platform has been developed from a sports-performance motion platform into a device specifically tailored for neurorehabilitation. It provides controlled roll, pitch and vertical translation, coupled with a markerless motion capture system that estimates the position of key body segments and the centre of mass in real time. By linking these kinematic data to an adaptive control model and VR-based exergames, the platform can deliver graded and repeatable balance challenges while maintaining patient safety through harness support and strict software limits on speed and amplitude. The rationale of the present study is to (a) verify that this non-CE-marked device can be used safely and feasibly in routine rehabilitation settings, (b) assess its usability and acceptability for both patients and staff, and (c) explore whether adding 3DoF Platform training to conventional therapy yields measurable benefits on balance, motor performance, cognition, fatigue, stress and quality of life across different neurological conditions. The central hypothesis is that the 3DoF Platform can be safely integrated into multidisciplinary neurorehabilitation pathways, is acceptable and usable for patients and clinicians, and, when combined with standard therapy, leads to superior improvements in balance, proprioception and functional outcomes compared with standard therapy alone.
Primary objectives:
Secondary objectives:
If the study confirms its hypotheses, the 3DoF Platform could offer clinicians a versatile, data-rich tool to deliver high-intensity, task-specific and engaging balance training within usual care settings. The integration of objective kinematic indicators with standard clinical scales may support more precise stratification of patients, early detection of balance impairments and fine-tuning of rehabilitation programmes over time. For patients, the combination of immersive exergames, personalised difficulty and robust safety measures has the potential to increase motivation, adherence and functional gains, ultimately reducing falls, enhancing autonomy in activities of daily living and improving overall quality of life. At system level, such technology-assisted rehabilitation could contribute to more efficient use of resources by shortening inpatient stays, facilitating safer discharge and enabling structured follow-up interventions in chronic neurological populations.
METHODS This multicenter interventional clinical study evaluates the 3DoF Platform in both healthy volunteers and patients with chronic neurological conditions. According to the protocol (Version 4.0, 27.03.2025), the study includes a total sample of 60 participants: 15 healthy subjects and 45 patients (15 with Parkinson's disease, 10 post-stroke, 10 with ALS, and 10 with mild cognitive impairment). The study follows a two-phase design. An initial phase involves healthy volunteers undergoing screening, device training and repeated testing sessions to assess safety, usability and feasibility, as well as to collect baseline normative data. A second phase adopts a simple randomization scheme assigning 40 patients to two groups: conventional rehabilitation alone or conventional rehabilitation combined with 3DoF Platform training. Both groups complete twelve 60-minute conventional therapy sessions, while the experimental arm receives additional sessions (up to 30 minutes) on the 3DoF Platform, including exercises and short exergame tasks. The interventions tested consist of: (1) standard rehabilitation delivered according to clinical practice, and (2) additional training on the dynamic 3DoF Platform, which provides controlled roll, pitch and vertical translation, markerless motion capture, and VR or monitor-based exergames. Outcome measures include the protocol's primary endpoints: usability, feasibility and safety of the device. Secondary endpoints evaluate the impact on balance, motor performance, cognitive functions, stress, fatigue and quality of life, as well as the comparison between the two treatment arms and the validation of adaptive exercise software. Statistical analyses described in the protocol include data summarization and comparison between the two study groups to evaluate treatment effects on all clinical and functional measures. All deviations, adverse events and system errors are documented to support safety and feasibility assessments. Regarding preliminary results, the study is currently awaiting the fourth revision by the Italian Ministry of Health. Nevertheless, the device has already been introduced in the clinical setting, and 22 pre-clinical tests on healthy participants, also requested by the Ministry, have been successfully completed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Treatment Group | Active Comparator | Participants receive conventional rehabilitation plus training with the 3DOF Balance Platform device. Both groups undergo 12 conventional rehabilitation sessions of at least 30 minutes each, three times per week, according to usual clinical practice. Participants in this group additionally receive 3DOF Balance Platform sessions of up to 15 minutes each under therapist supervision. |
|
| Control Group | Other | Participants receive conventional rehabilitation only, according to usual clinical practice. Both groups undergo 12 conventional rehabilitation sessions of at least 30 minutes each, three times per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3DOF balance board robotic platform group | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Safety of the 3DoF platform for participants and operators will be assessed by recording the incidence and frequency of adverse events reported by the participant or observed by the operator during each study session. Adverse events include, for example, falls or episodes of instability during platform use, post-exercise musculoskeletal pain, technical malfunctions of the platform, dizziness or nausea related to vestibular stimulation or virtual reality, and premature interruption of the session by the participant or therapist. | From the first session to the end of the intervention, up to 4 weeks |
| Evaluation of System Usability Scale (SUS) | SUS consists of a series of 10 questions, which users answer using a 5-point Likert scale ranging from "strongly disagree" to "strongly agree." The questions are designed to assess various aspects of usability, such as ease of use, complexity and user satisfaction. Total score ranges from 0 to 100, with higher scores indicating better usability. | Session 12 (final evaluation, Week 4). |
| Evaluation of Quality of Care Through the Patient's Eyes (QUEST) 2.0 | This QUEST 2.0 questionnaire is used to assess patient satisfaction with healthcare services. "QUEST" stands for "Quality of Care Through the Patient's Eyes" and was developed to measure patients' perceptions of the quality of healthcare services and support. Version 2.0 is an update of the original questionnaire designed to make it more comprehensive and suitable for various healthcare settings. Reported as total questionnaire score; higher scores indicate greater satisfaction with the device and related services. | Session 12 (final evaluation, Week 4). |
| Evaluation of Technology Assisted Rehabilitation Patient Perception Questionnaire | To assess the patient perception of the technology assisted rehabilitation using the Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q). The TARPP-Q consists of 10 questions with multiple choice answers, totalling 29 items. The Questionnaire assesses patients' personal experiences and perceptions of technology assisted rehabilitation, including aspects like usability, positive attitude, hindrance perception, and distress. Reported as total questionnaire score; higher scores indicate a more positive perception of technology-assisted rehabilitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Berg Balance Scale | Change in balance performance assessed with the Berg Balance Scale (BBS). The BBS evaluates balance and stability across 14 tasks. . Total score ranges from 0 to 56, with higher scores indicating better balance performance. | Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Lunetta, MD | Contact | +39 02 50725266 | christian.lunetta@icsmaugeri.it |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Conventional Rehabilitation | Other | 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. |
|
| Session 12 (final evaluation, Week 4). |
| Change from baseline in State-Trait Anxiety Inventory | STAI: This stands for "State-Trait Anxiety Inventory," a psychometric questionnaire used to assess anxiety levels in adults. There are two versions of the questionnaire: one measures state anxiety (momentary, situational) and the other measures trait anxiety (stable, dispositional). Total score ranges from 20 to 80, with higher scores indicating greater anxiety. | Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
| Change From Baseline in Perceived Stress Scale (PSS) | Change in self-reported stress related to the activity performed during device use, assessed with the Perceived Stress Scale (PSS). Higher scores indicate greater perceived stress. | Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
| Change From Baseline in Timed Up and Go (TUG) |
Change in mobility and balance assessed with the Timed Up and Go (TUG) test, defined as the time required to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Lower values indicate better performance. |
| Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
| Change From Baseline in 6-Minute Walk Test (6MWT) | Change in functional walking capacity assessed with the 6-Minute Walk Test (6MWT), defined as the distance walked in 6 minutes. Higher values indicate better performance. | Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
| Change From Baseline in 10-Meter Walk Test (10MWT) | Change in gait performance assessed with the 10-Meter Walk Test (10MWT), used to evaluate walking speed over 10 meters. Higher values indicate better performance. Time Frame: | Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
| Change From Baseline in Fugl-Meyer Assessment Score | Change in motor, sensory, and balance function assessed with the Fugl-Meyer Assessment. Higher scores indicate better neurological function. | Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
| Change From Baseline in Exergame Path Completion Time | Change in device-recorded performance during the exergame, defined as the time required to complete the exergame path, measured in seconds. Lower values indicate better performance. | Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
| Change From Baseline in quality of life (EuroQol-5D) | Change in health-related quality of life assessed with the EuroQol-5D (EQ-5D). Score ranges from 0 to 100, with higher scores indicating better perceived health status. | Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
| Psychosocial Impact of Assistive Devices Scale (PIADS) | Psychosocial impact of the device assessed at the end of treatment with the Psychosocial Impact of Assistive Devices Scale (PIADS), including perceived effects on functional capability, self-efficacy, and participation. Higher scores indicate a more positive psychosocial impact of the device. | Session 12 (final evaluation, Week 4) |
| Change From Baseline in Trail Making Test Part A Performance | Change in cognitive performance assessed with Trail Making Test Part A. Lower values indicate better performance. | Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
| Change From Baseline in Stroop Test Performance | Change in cognitive performance assessed with the Stroop Test. Higher scores indicate better cognitive performance. | Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
| Change From Baseline in Digit Span Test Score | Change in working memory and attention assessed with the Digit Span Test. Higher scores indicate better working memory performance. | Baseline (Session 1) and Session 12 (final evaluation, Week 4) |
| Change From Baseline in Target Collection Accuracy | Change in device-recorded exergame performance, defined as the percentage of targets successfully collected during the task. Higher values indicate better performance. | Baseline (Session 1, Week 1) and Session 12 (Week 4) |
| Change From Baseline in Obstacle Avoidance Accuracy | Change in device-recorded exergame performance, defined as the percentage of obstacles correctly avoided during the task. Higher values indicate better performance. | Baseline (Session 1, Week 1) and Session 12 (Week 4) |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided