Clinical trial NCT06519630: REHABOTICS: Integrated Rehabilitation System for People With Motor Disabilities
Official title: REHABOTICS: Integrated Rehabilitation System for People With Motor Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spasticity, Muscle
Upper Extremity Dysfunction
Lead sponsor: National Technical University of Athens
Sponsor class: OTHER
Collaborators: name: University of Ioannina
name: Physioloft, Physiotherapy Center
name: University of Peloponnese
name: Ostracon Ltd
First posted: 2024-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* stroke pathology,
* Ashworth Scale ≤ 3,
* 6 months maximum time since the incident

Exclusion Criteria:

* Presence of neurological pathologies that affect hand motion (Parkinson's disease)
* Musculoskeletal deficits that affect normal finger range of motion (e.g. finger fractures, joint stiffness/pain, arthritis that affect joint motion)
* Ashworth Scale \> 3,
* Over 6 months since the incident

Primary outcomes:
measure: Ashworth Scale measured by physiotherapists
timeFrame: Change from baseline to 5 weeks
measure: Box and Block Test score measured by physiotherapists
timeFrame: Change from baseline to 5 weeks
Secondary outcomes:
measure: Device Evaluation Satisfaction utilizing questionnaires for patients
timeFrame: Administered in the 5th week
measure: Device Evaluation Satisfaction utilizing questionnaires for physiotherapists
timeFrame: 1 year
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Physioloft, Physiotherapy Center
state: Attiki
Study officials:
affiliation: Physioloft
name: Georgios Papagiannis, PhD
role: PRINCIPAL_INVESTIGATOR
References: