StrokeNCT05985889
Comparison of Innovative Rehabilitation Treatments and Examination of Their Effectiveness in Stroke Patients
A study testing Robot, Fizio and EXE1 in people with Stroke, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
We perform a comparison of several groups. We would like to determine how robotic and virtual therapy is most effective in the treatment of stroke patients. We place great emphasis on walking speed, quality of life, coordination and changes in walking distance. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robot, Fizio and EXE1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteHungary
- Study dates
- 8 Jul 2023to 30 Aug 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post stroke 6MWT : 120> minimum after stroke 3 days be a stroke patient first stroke hemiplegia
Who cannot join
- multiple strokes, inability to stand and walk, cognitive function disorder does not reach 50 meters with a minimal walking aid Alcohol Sever heart problem sever demeanor alcoholism drug problems Drug
Trial locations and contacts
1 site in 1 country.
About this study
We perform a comparison of several groups. We would like to determine how robotic and virtual therapy is most effective in the treatment of stroke patients. We place great emphasis on walking speed, quality of life, coordination and changes in walking distance.
- Conditions
- Stroke
- Being tested
- Robot, Fizio, EXE1, EXE2, EXE+ROB
- Keywords
- robotic, stroke, rehabilitation, virtual rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RobotOther
Also called ROB
You have to walk with a robot mounted on your lower limb. To move, to change direction.
FizioOther
Patients do state-funded physical therapy.
EXE1Other
Patients undergo intensive virtual reality therapy once a day.
EXE2Other
Patients undergo intensive virtual reality therapy twice a day.
EXE+ROBOther
The patients intensively performed 1 virtual reality therapy and 1 robotic therapy every day.
| Study group | Role | What they receive |
|---|---|---|
| Robotic | Experimental | They performed training with a robot 15 times over 3 weeks. Receives: Other: Robot |
| Fizio | Experimental | They receive physiotherapy treatment. Receives: Other: Fizio |
| EXE1 | Experimental | Virtual reality treatment is performed once a day. Receives: Other: EXE1 |
| EXE2 | Experimental | Virtual reality treatment is performed twice a day. Receives: Other: EXE2 |
| EXE+ROB | Experimental | Virtual and robotic treatments are performed once a day. Receives: Other: EXE+ROB |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS score
Measured: 3 weeks (0-5 score, high score better)
Secondary outcomes (4)
Barthel index score
Measured: 3 weeks
Berg balance score
Measured: 3 weeks (0-30, high score better)
6MWT
meter
Measured: 3 weeks
10m gait speed
m/s
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 Jul 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985889
- Sponsor's protocol ID
- IKEB/2023/01
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Innovative Rehabilitation Treatments and Examination of Their Effectiveness in Stroke Patients
- ClinicalTrials.gov ID
- NCT05985889
- Acronym / sponsor ID
- IKEB/2023/01
- Conditions
- Stroke
- Keywords
- robotic, stroke, rehabilitation, virtual rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 8 Jul 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 14 Aug 2023 (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.
We perform a comparison of several groups. We would like to determine how robotic and virtual therapy is most effective in the treatment of stroke patients. We place great emphasis on walking speed, quality of life, coordination and changes in walking distance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Robotic | Experimental | Other: RobotThey performed training with a robot 15 times over 3 weeks. |
| Fizio | Experimental | Other: FizioThey receive physiotherapy treatment. |
| EXE1 | Experimental | Other: EXE1Virtual reality treatment is performed once a day. |
| EXE2 | Experimental | Other: EXE2Virtual reality treatment is performed twice a day. |
| EXE+ROB | Experimental | Other: EXE+ROBVirtual and robotic treatments are performed once a day. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- post stroke 6MWT : 120> minimum after stroke 3 days be a stroke patient first stroke hemiplegia
Key exclusion criteria (1 listed)
- multiple strokes, inability to stand and walk, cognitive function disorder does not reach 50 meters with a minimal walking aid Alcohol Sever heart problem sever demeanor alcoholism drug problems Drug
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 |
|---|---|---|
| RobotAlso: ROBYou have to walk with a robot mounted on your lower limb. To move, to change direction. | Other | Robotic |
| FizioPatients do state-funded physical therapy. | Other | Fizio |
| EXE1Patients undergo intensive virtual reality therapy once a day. | Other | EXE1 |
| EXE2Patients undergo intensive virtual reality therapy twice a day. | Other | EXE2 |
| EXE+ROBThe patients intensively performed 1 virtual reality therapy and 1 robotic therapy every day. | Other | EXE+ROB |
Primary outcome
mRS score
Time frame: 3 weeks (0-5 score, high score better)
4 secondary outcomes
Barthel index score
Time frame: 3 weeks
Berg balance score
Time frame: 3 weeks (0-30, high score better)
6MWT
Time frame: 3 weeks
10m gait speed
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot, Fizio and EXE1 in people with Stroke, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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 Hungary. 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?
Results are not available in the source record.
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?
mRS score (time frame: 3 weeks (0-5 score, high score better)). 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 14 Aug 2023.