StrokeNCT05947773
Effect of Robotic Treatments on Motor Functions in Subacute Stroke Patients
A study testing Learning to walk with a robot and Walking group in people with Stroke, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
We are conducting a three-group comparative study on stroke patients. The treatment is started in a subacute state and completed in the hospital. The essence of robot-assisted treatments is faster recovery and better learning to walk. The group will do a special walking exercise with a robot. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Learning to walk with a robot and Walking group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteHungary
- Study dates
- 9 Jul 2023to 1 Sep 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 are conducting a three-group comparative study on stroke patients. The treatment is started in a subacute state and completed in the hospital. The essence of robot-assisted treatments is faster recovery and better learning to walk. The group will do a special walking exercise with a robot. The walking group does the same training, only without robotic assistance. The control group will receive physiotherapy treatments financed by the state. Control examination after 3 weeks.
- Conditions
- Stroke
- Being tested
- Learning to walk with a robot, Walking group, Control group
- Keywords
- robotic, stroke, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning to walk with a robotOther
Also called ROB
The patients completed a 1-hour learning to walk program using a soft exoskeleton. The protocol includes several difficult parts of the walk. (Walking protocol)
Walking groupOther
Also called WALK
The walking protocol was performed without robotic assistance for 1 hour every day for 3 weeks.
Control groupOther
Also called CON
The control group performed the physiotherapy treatment for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Robotically treated patient | Experimental | They performed training with a robot 15 times over 3 weeks. Receives: Other: Learning to walk with a robot |
| Walking training | Experimental | Walking exercises were performed without a robot. Receives: Other: Walking group |
| Control group | Experimental | Physiotherapy treatment was carried out by the patients. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS)
stroke, diagnostic, quality of life
Measured: 3 weeks (0-5 score, high score better)
Secondary outcomes (4)
Barthel Index for Activities of Daily Living (ADL)
stroke quality of life
Measured: 3 weeks
Berg Balance Scale
balance test
Measured: 3 weeks (0-30, high score better)
10-m maximal walking speed
high speed test
Measured: 3 weeks
6MWT
walking test
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 posted17 Jul 2023
- Study start9 Jul 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion1 Sep 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
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
- NCT05947773
- Sponsor's protocol ID
- IKEB/2022/02
- Status last verified
- Aug 2023
- First submitted
- 9 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Robotic Treatments on Motor Functions in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT05947773
- Acronym / sponsor ID
- IKEB/2022/02
- Conditions
- Stroke
- Keywords
- robotic, stroke, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 9 Jul 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 17 Jul 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 are conducting a three-group comparative study on stroke patients. The treatment is started in a subacute state and completed in the hospital. The essence of robot-assisted treatments is faster recovery and better learning to walk. The group will do a special walking exercise with a robot. The walking group does the same training, only without robotic assistance. The control group will receive physiotherapy treatments financed by the state. Control examination after 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robotically treated patient | Experimental | Other: Learning to walk with a robotThey performed training with a robot 15 times over 3 weeks. |
| Walking training | Experimental | Other: Walking groupWalking exercises were performed without a robot. |
| Control group | Experimental | Other: Control groupPhysiotherapy treatment was carried out by the patients. |
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 |
|---|---|---|
| Learning to walk with a robotAlso: ROBThe patients completed a 1-hour learning to walk program using a soft exoskeleton. The protocol includes several difficult parts of the walk. (Walking protocol) | Other | Robotically treated patient |
| Walking groupAlso: WALKThe walking protocol was performed without robotic assistance for 1 hour every day for 3 weeks. | Other | Walking training |
| Control groupAlso: CONThe control group performed the physiotherapy treatment for 3 weeks. | Other | Control group |
Primary outcome
Modified Rankin Scale (mRS)
Time frame: 3 weeks (0-5 score, high score better)
stroke, diagnostic, quality of life
4 secondary outcomes
Barthel Index for Activities of Daily Living (ADL)
Time frame: 3 weeks
Berg Balance Scale
Time frame: 3 weeks (0-30, high score better)
10-m maximal walking speed
Time frame: 3 weeks
6MWT
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 4 Aug 2023.
- Related InfoLink provided by the sponsor.
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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 Learning to walk with a robot and Walking group 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 4 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?
Modified Rankin Scale (mRS) (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 4 Aug 2023.