StrokeNCT06519630
REHABOTICS: Integrated Rehabilitation System for People With Motor Disabilities
A study testing Rehabotics Physiotherapy and Traditional Physiotherapy in people with Stroke and Spasticity, Muscle, run by Pantelis Syringas at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Stroke, Spasticity, Muscle, Upper Extremity Dysfunction
- What is being tested?
- Rehabotics Physiotherapy and Traditional Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 4 Nov 2022to 3 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stroke pathology,
- Ashworth Scale ≤ 3,
- 6 months maximum time since the incident
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- will measure various motor and kinematic parameters of the extremity in order to assess the patient's condition and progress, and
- 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
- Being tested
- Rehabotics Physiotherapy, Traditional Physiotherapy
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabotics PhysiotherapyDevice
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 PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabotics Intervention Group | Experimental | Rehabotics Intervention Group received Physiotherapy through the Rehabotics system. Receives: Device: Rehabotics Physiotherapy |
| Traditional Physiotherapy Group | Active comparator | Traditional Physiotherapy Group received Physiotherapy. Receives: Other: Traditional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to 5 weeks
Secondary outcomes (2)
Device Evaluation Satisfaction utilizing questionnaires for patients
This outcome aims to explore the patient satisfaction with the device. Questionnaires will be utilized to gather detailed feedback from patients. These questionnaires will help capture their experiences, satisfaction, captivation and any challenges encountered during the use of Rehabotics.
The patient questionnaire will cover:
Comfort and Usability, Perceived Effectiveness (how patients perceive the impact of Rehabotics in their Rehabilitation progress), Engagement and Motivation, Overall Satisfaction.
Based on the results obtained from the questionnaires, we will be able to identify potential improvements and enhancements for the device, ensuring it better meets the needs and expectations of patients.
Measured: Administered in the 5th week
Device Evaluation Satisfaction utilizing questionnaires for physiotherapists
This outcome aims to explore the physiotherapist satisfaction with the device. Questionnaires will be utilized to gather detailed feedback from physiotherapists. These questionnaires will help capture their experiences, satisfaction, captivation and any challenges encountered during the use of Rehabotics.
The physiotherapist questionnaire will include sections on:
Ease of Use, Effectiveness, Patient Engagement, Technical Issues, Comparison to Traditional Methods
The results will help refine the design and functionality of Rehabotics, ultimately contributing to more effective and satisfying rehabilitation tool for clinical use.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start4 Nov 2022
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pantelis Syringas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ioannina, Physioloft, Physiotherapy Center, University of Peloponnese, Ostracon Ltd
- Responsible party
- Sponsor-investigator, Pantelis Syringas, National Technical University of Athens
- Investigators
- Georgios Papagiannis, PhD, Principal investigator, Physioloft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519630
- Sponsor's protocol ID
- REHABOTICS_2022_01
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data cannot be provided due to confidentiality and privacy regulations designed to protect individuals' personal information. Upon a formal request, data may be able to be provided anonymized to protect patients' privacy.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REHABOTICS: Integrated Rehabilitation System for People With Motor Disabilities
- ClinicalTrials.gov ID
- NCT06519630
- Acronym / sponsor ID
- REHABOTICS_2022_01
- Conditions
- Stroke, Spasticity, Muscle, Upper Extremity Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pantelis SyringasUniversity, hospital or other
- Collaborators
- University of Ioannina, Physioloft, Physiotherapy Center, University of Peloponnese, Ostracon Ltd
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- will measure various motor and kinematic parameters of the extremity in order to assess the patient's condition and progress, and
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabotics Intervention Group | Experimental | Device: Rehabotics PhysiotherapyRehabotics Intervention Group received Physiotherapy through the Rehabotics system. |
| Traditional Physiotherapy Group | Active comparator | Other: Traditional PhysiotherapyTraditional Physiotherapy Group received Physiotherapy. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stroke pathology,
- Ashworth Scale ≤ 3,
- 6 months maximum time since the incident
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabotics PhysiotherapyThe 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. | Device | Rehabotics Intervention Group |
| Traditional PhysiotherapySimilarly, 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. | Other | Traditional Physiotherapy Group |
Primary outcome
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.
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.
2 secondary outcomes
Device Evaluation Satisfaction utilizing questionnaires for patients
Time frame: Administered in the 5th week
Device Evaluation Satisfaction utilizing questionnaires for physiotherapists
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No. Patient data cannot be provided due to confidentiality and privacy regulations designed to protect individuals' personal information. Upon a formal request, data may be able to be provided anonymized to protect patients' privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Papagiannis, PhD principal investigator
Physioloft
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabotics Physiotherapy and Traditional Physiotherapy in people with Stroke and Spasticity, Muscle, run by Pantelis Syringas at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ashworth Scale measured by physiotherapists (time frame: Change from baseline to 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.