REHABOTICS: Integrated Rehabilitation System for People With Motor Disabilities

NCT06519630 | Completed

• 1 other identifier: REHABOTICS_2022_01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.will measure various motor and kinematic parameters of the extremity in order to assess the patient's condition and progress, and
2. 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.

Conditions

Stroke; Spasticity, Muscle; Upper Extremity Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Device Evaluation Satisfaction utilizing questionnaires for patients

  Administered in the 5th week

• Device Evaluation Satisfaction utilizing questionnaires for physiotherapists

  1 year

Study Arms (2)

Rehabotics Intervention Group

EXPERIMENTAL

Rehabotics Intervention Group received Physiotherapy through the Rehabotics system.

Device: Rehabotics Physiotherapy

Traditional Physiotherapy Group

ACTIVE COMPARATOR

Traditional Physiotherapy Group received Physiotherapy.

Other: Traditional Physiotherapy

Interventions

Rehabotics Physiotherapy 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.

Rehabotics Intervention Group

Traditional Physiotherapy 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.

Traditional Physiotherapy Group

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pantelis Syringas: lead
• University of Ioannina: collaborator
• Physioloft, Physiotherapy Center: collaborator
• University of Peloponnese: collaborator
• Ostracon Ltd: collaborator

Study Sites (1)

Physioloft, Physiotherapy Center

Athens, Attica, 14562, Greece

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Georgios Papagiannis, PhD

  Physioloft

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 25, 2024
• Study Start: November 4, 2022
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)