REHABOTICS: Integrated Rehabilitation System for People With Motor Disabilities

NCT ID: NCT06519630

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-04
• Study Completion Date: 2023-11-03

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.

Conditions

Stroke; Spasticity, Muscle; Upper Extremity Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rehabotics Intervention Group

Rehabotics Intervention Group received Physiotherapy through the Rehabotics system.

Group Type: EXPERIMENTAL

Rehabotics Physiotherapy

Intervention Type: DEVICE

The intervention will be consisted of sessions for participants in the intervention group which includes a repetition of each of the four Sollerman AR Games named, Wallet, Key, Jar, Screwdriver and one repetition of Balloon Pop. Participants will interact with the AR Box and Block Test (BBT) and the serious games under controlled conditions. A clinician will be present throughout the whole session providing help if participants encounter any difficulties. Following the games, the clinician will initiate a stretching program using the Active Exoskeletal Aid, performing 3 sets of 10 repetitions on the finger flexors of the patient's hand. Each rehabilitation session will last 30 minutes and will be conducted three times a week. Similarly, the traditional physiotherapy training program will be prescribed for the control group and will be consisted of sessions lasting 30 minutes per day, three days per week. Both programs duration will be five weeks.

Traditional Physiotherapy Group

Traditional Physiotherapy Group received Physiotherapy.

Group Type: ACTIVE_COMPARATOR

Traditional Physiotherapy

Intervention Type: OTHER

Similarly, the hand functional training program prescribed for the control group consisted of sessions lasting 30 minutes per day, three days per week. Both programs lasted for five weeks and were designed by two clinical experts.

Interventions

Rehabotics Physiotherapy

The intervention will be consisted of sessions for participants in the intervention group which includes a repetition of each of the four Sollerman AR Games named, Wallet, Key, Jar, Screwdriver and one repetition of Balloon Pop. Participants will interact with the AR Box and Block Test (BBT) and the serious games under controlled conditions. A clinician will be present throughout the whole session providing help if participants encounter any difficulties. Following the games, the clinician will initiate a stretching program using the Active Exoskeletal Aid, performing 3 sets of 10 repetitions on the finger flexors of the patient's hand. Each rehabilitation session will last 30 minutes and will be conducted three times a week. Similarly, the traditional physiotherapy training program will be prescribed for the control group and will be consisted of sessions lasting 30 minutes per day, three days per week. Both programs duration will be five weeks.

Intervention Type: DEVICE

Traditional Physiotherapy

Similarly, the hand functional training program prescribed for the control group consisted of sessions lasting 30 minutes per day, three days per week. Both programs lasted for five weeks and were designed by two clinical experts.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ioannina

OTHER

Sponsor Role: collaborator

Physioloft, Physiotherapy Center

UNKNOWN

Sponsor Role: collaborator

University of Peloponnese

OTHER

Sponsor Role: collaborator

Ostracon Ltd

UNKNOWN

Sponsor Role: collaborator

Pantelis Syringas

OTHER

Sponsor Role: lead

Responsible Party

Pantelis Syringas

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Georgios Papagiannis, PhD

Role: PRINCIPAL_INVESTIGATOR

Physioloft

Locations

Physioloft, Physiotherapy Center

Athens, Attica, Greece

Countries

Greece

Other Identifiers

REHABOTICS_2022_01

Identifier Type: -

Identifier Source: org_study_id