NCT07468149

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 9, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

RoboticsSerious GamesUpper Hand Spasticity

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • AROM measured by physiotherapists using gioniometry

    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

Study Arms (1)

Rehabotics Physiotherapy

EXPERIMENTAL

Arm receiving Physiotherapy through the Rehabotics system

Device: Rehabotics Physiotherapy

Interventions

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.

Rehabotics Physiotherapy

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physioloft, Physiotherapy Center

Athens, Attica, 14562, Greece

Location

Related Publications (1)

  • https://doi.org/10.3390/healthcare13010091

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Georgios Papagiannis, PhD

    Physioloft

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start

January 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations