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.

NCT07502937 | Not Yet Recruiting

• 1 other identifier: 3DoF - CTSM125-24 e MON04_24
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neurological Disorders; Health Adult Subjects

Keywords

3DoF Platform; proprioception; exergame; neurological rehabilitation

Outcome Measures

Primary Outcomes (6)

• 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.

  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)

Secondary Outcomes (13)

• 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)

Study Arms (2)

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.

Device: 3DOF balance board robotic platform group

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.

Other: Conventional Rehabilitation

Interventions

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.

Robotic Treatment Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients: adults aged 18 to 80 years.
• Patients: confirmed diagnosis of one of the following chronic neurological conditions: stroke, Parkinson's disease, amyotrophic lateral sclerosis (ALS), or mild cognitive impairment (MCI).
• Patients: able to understand and follow study procedures and provide informed consent.
• Healthy volunteers: adults aged 18 to 65 years.
• Healthy volunteers: able to understand and follow study procedures and provide informed consent.
• Healthy volunteers: rehabilitation staff members from the participating centers.

You may not qualify if:

• Patients: severe psychiatric disorders or cognitive disorders that impair the ability to complete cognitive tests and self-report questionnaires.
• Patients: unable to provide informed consent.
• Patients: moderate to severe cognitive impairment, defined as an ECAS score below 81.92 in participants with ALS or a Raven's Matrices score below 18.36 in participants with mild cognitive impairment.
• Patients: neurological or physical conditions that significantly limit lower-limb use and prevent standing on the platform, including lower-limb muscle strength of 3 or less on the Medical Research Council (MRC) scale.
• Patients: body weight greater than 100 kg.
• Patients: current or recent participation, within the last 3 months, in other rehabilitation programs or interventions that could affect study results.
• Patients: alcohol or substance dependence that could compromise safety during training sessions.
• Patients: unstable health conditions that could make use of the 3DoF Platform and/or head-mounted display unsafe or inappropriate, such as severe cardiovascular disease, severe respiratory disease, or other unstable medical conditions.
• Healthy volunteers: health conditions that could make use of the 3DoF Platform and/or head-mounted display unsafe or inappropriate, such as severe cardiovascular disease, severe respiratory disease, or other unstable medical conditions.
• Healthy volunteers: any motor disability.

Sponsors & Collaborators

• University of Pavia: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator

MeSH Terms

Conditions

Nervous System Diseases

Central Study Contacts

Christian Lunetta, MD

CONTACT

+39 02 50725266; christian.lunetta@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 31, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share