REHABOTICS: Integrated Rehabilitation System for People With Motor Disabilities
NCT Number: NCT06519630
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Spasticity, Muscle|Upper Extremity Dysfunction
Interventions: DEVICE: Rehabotics Physiotherapy|OTHER: Traditional Physiotherapy
Sponsor: Pantelis Syringas
Collaborators: University of Ioannina|Physioloft, Physiotherapy Center|University of Peloponnese|Ostracon Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-11-04
Completion Date: 2023-11-03
Locations: Physioloft, Physiotherapy Center, Athens, Attiki, 14562, Greece

Summary:
The goal of the Rehabotics project is the development of a comprehensive rehabilitation system to provide highly individualized treatment of upper limb function in patients with motor disorders due to acquired brain damage (eg stroke) or neurodegenerative disease (eg sclerosis), having as central pillar the integration of robotic systems and support functions. A key part of the proposed system is the development and evaluation of an innovative robotic extraskeletal device that will be applied in the form of a glove to the diseased limb of the neurological patient.

The proposed robotic system:

1. will measure various motor and kinematic parameters of the extremity in order to assess the patient's condition and progress, and
2. will offer a specialized rehabilitation program (therapeutic exercises, retraining of functional movements and support of daily activities) through an interactive virtual environment provided by the Rehabotics platform.

The aim is to provide an environment for the provision of a high level of treatment and support services to patients with hand mobility disorders which will take place both in the clinical environment and in the patient's home through telemedicine applications.

To demonstrate the efficiency of the proposed system, Rehabotics will be applied on post-stoke patients for rehabilitation while also using a control group receiving traditional physiotherapy.

Primary Outcome Measures: Ashworth Scale measured by physiotherapists, This outcome aims to explore the therapeutic potential of Rehabotics in stroke rehabilitation, demonstrating improved hand motor function through the integration of robotics and Augmented Reality games, measured by Ashworth Scale \[AS\].

The AS is a key instrument for evaluating spasticity in individuals with upper extremity mobility challenges during rehabilitation. This assessment uses a scoring system from 0 to 4, where higher scores denote greater difficulty in finger movement, and lower scores indicate easier finger movement., Change from baseline to 5 weeks|Box and Block Test score measured by physiotherapists, This outcome aims to explore the therapeutic potential of Rehabotics in stroke rehabilitation, demonstrating improved hand motor function through the integration of robotics and Augmented Reality games, measured by the Box and Block Test \[BBT\] score.

The BBT consists of a wooden box divided into two compartments by a partition and includes 150 blocks. During the BBT administration, the patient is instructed to move as many blocks as possible, one by one, from one compartment to the other within 60 seconds. The higher the number of blocks moved indicate better manual dexterity., Change from baseline to 5 weeks
Secondary Outcome Measures: Device Evaluation Satisfaction utilizing questionnaires for patients, This outcome aims to explore the patient satisfaction with the device. Questionnaires will be utilized to gather detailed feedback from patients. These questionnaires will help capture their experiences, satisfaction, captivation and any challenges encountered during the use of Rehabotics.

The patient questionnaire will cover:

Comfort and Usability, Perceived Effectiveness (how patients perceive the impact of Rehabotics in their Rehabilitation progress), Engagement and Motivation, Overall Satisfaction.

Based on the results obtained from the questionnaires, we will be able to identify potential improvements and enhancements for the device, ensuring it better meets the needs and expectations of patients., Administered in the 5th week|Device Evaluation Satisfaction utilizing questionnaires for physiotherapists, This outcome aims to explore the physiotherapist satisfaction with the device. Questionnaires will be utilized to gather detailed feedback from physiotherapists. These questionnaires will help capture their experiences, satisfaction, captivation and any challenges encountered during the use of Rehabotics.

The physiotherapist questionnaire will include sections on:

Ease of Use, Effectiveness, Patient Engagement, Technical Issues, Comparison to Traditional Methods

The results will help refine the design and functionality of Rehabotics, ultimately contributing to more effective and satisfying rehabilitation tool for clinical use., 1 year