REHABOTICS: Physiotherapy for Hand Spasticity After Stroke Using Robotics and AR Serious Games
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Attica
-
Athens, Attica, Greece, 14562
- Physioloft, Physiotherapy Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Georgios Papagiannis, PhD, Physioloft
Publications and helpful links
General Publications
- https://doi.org/10.3390/healthcare13010091
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- REHABOTICS_02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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