- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468149
REHABOTICS: Physiotherapy for Hand Spasticity After Stroke Using Robotics and AR Serious Games
March 9, 2026 updated by: Pantelis Syringas
Rehabotics is a comprehensive rehabilitation system designed to deliver individualized upper-limb therapy for patients with motor impairments, particularly after stroke.
Its core components include an exoskeletal robotic aid for assisted hand training and an interactive augmented reality platform for rehabilitation exercises and functional task practice.
The system supports both treatment and assessment by enabling the monitoring of motor performance and patient progress through quantitative data.
The overall aim of Rehabotics is to enhance the quality, intensity, and personalization of hand rehabilitation in clinical settings, with the potential to support remote care applications in the future.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Attica
-
Athens, Attica, Greece, 14562
- Physioloft, Physiotherapy Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rehabotics Physiotherapy
Arm receiving Physiotherapy through the Rehabotics system
|
A supervised 5-week upper-limb rehabilitation program using the Rehabotics system, delivered in 3 sessions per week, with each session lasting 30 minutes.
Each session combined two components: (1) task-oriented training through an augmented reality serious-games platform using markerless hand tracking with a standard RGB camera, and (2) assisted stretching of the affected finger flexor muscles using the Active Exoskeletal Aid.
The AR component included grip-specific functional tasks designed to simulate activities of daily living.
The exoskeletal component provided repetitive, therapist-adjustable finger stretching through servo motor-driven movement, with programmable parameters including extension speed, maximum extension angle, and return speed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box and Block Test score measured by physiotherapists
Time Frame: Change from baseline to 5 weeks
|
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
|
|
Ashworth Scale measured by physiotherapists
Time Frame: Change from baseline to 5 weeks
|
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
|
|
AROM measured by physiotherapists using gioniometry
Time Frame: Change from baseline to 5 weeks
|
This outcome aims to explore the therapeutic potential of Rehabotics in stroke rehabilitation by demonstrating improvements in active finger mobility through the integration of robotics and Augmented Reality games, measured by active range of motion (AROM).
In this study, AROM was assessed as Total Active Motion (TAM), which is defined as the sum of active flexion at the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of the finger, minus any extension deficits at these joints.
Measurements were obtained using a finger goniometer, and higher TAM values indicate better active finger movement and joint mobility.
|
Change from baseline to 5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Georgios Papagiannis, PhD, Physioloft
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- https://doi.org/10.3390/healthcare13010091
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
March 9, 2026
First Submitted That Met QC Criteria
March 9, 2026
First Posted (Actual)
March 12, 2026
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
March 9, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REHABOTICS_02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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