Stroke, AcuteNCT05300867
Robotic Rehabilitation Treatment of Stroke Patients
A study testing Neurorehabilitation and Physiotherapy in people with Stroke, Acute and Stroke, Ischemic, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
Storke results in severe deterioration in quality of life and exercise. Severe disorders need to be treated as soon as possible and they need to be rehabilitated quickly in order for motor functions to develop properly. In the acute / subacute phase, patients are given robotic treatment. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, Stroke, Ischemic
- What is being tested?
- Neurorehabilitation and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHungary
- Study dates
- 1 Apr 2022to 1 Nov 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- post stroke 6MWT : 120> minimum after stroke 3 days
Who cannot join
- Sever heart problem sever demeanor alcoholism drug problems
Trial locations and contacts
1 site in 1 country.
About this study
Storke results in severe deterioration in quality of life and exercise. Severe disorders need to be treated as soon as possible and they need to be rehabilitated quickly in order for motor functions to develop properly. In the acute / subacute phase, patients are given robotic treatment. In addition to the study of mtoros functions, the study of gait and codination is the primary result. Patients treated with soft exoskeleton receive 15 treatments and movement testing is performed continuously. Members of the control group receive standard rehabilitation therapy. After 3 weeks, both groups will participate in a control study and then in a repeat control study at week 6. Our main goal is to compare the results and determine the efficiency of the robotic device.
- Conditions
- Stroke, Acute, Stroke, Ischemic
- Being tested
- Neurorehabilitation, Physiotherapy
- Keywords
- balance, soft exoskeleton, walk, robotic
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurorehabilitationOther
Also called Rob group
Neurorehabilitation with soft exsoskeleton robotic 3-week-long
PhysiotherapyOther
Also called Controll groum
Physiotherapy 3-week-long
| Study group | Role | What they receive |
|---|---|---|
| Robotic | Active comparator | Not described Receives: Other: Neurorehabilitation |
| Controll | Active comparator | Not described Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualiti of life measured by Barthel index
quetionnaire
Measured: 3 weeks
gait/functional test
6 minute walk test (m)
Measured: 3 weeks
gait/functional test
10 m walk test (m/s)
Measured: 3 weeks
balance test
Berg balance test
Measured: 3 weeks
postural control test
posturography
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 posted29 Mar 2022
- Study start1 Apr 2022
- Primary completion1 Sep 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- 2 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
- NCT05300867
- Sponsor's protocol ID
- IKEB2021/10
- Status last verified
- Aug 2023
- First submitted
- 19 Mar 2022
- Last updated
- 3 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 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Rehabilitation Treatment of Stroke Patients
- ClinicalTrials.gov ID
- NCT05300867
- Acronym / sponsor ID
- IKEB2021/10
- Conditions
- Stroke, Acute, Stroke, Ischemic
- Keywords
- balance, soft exoskeleton, walk, robotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 29 Mar 2022 (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.
Storke results in severe deterioration in quality of life and exercise. Severe disorders need to be treated as soon as possible and they need to be rehabilitated quickly in order for motor functions to develop properly. In the acute / subacute phase, patients are given robotic treatment. In addition to the study of mtoros functions, the study of gait and codination is the primary result. Patients treated with soft exoskeleton receive 15 treatments and movement testing is performed continuously. Members of the control group receive standard rehabilitation therapy. After 3 weeks, both groups will participate in a control study and then in a repeat control study at week 6. Our main goal is to compare the results and determine the efficiency of the robotic device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic | Active comparator | Other: Neurorehabilitation |
| Controll | Active comparator | Other: Physiotherapy |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- post stroke 6MWT : 120> minimum after stroke 3 days
Key exclusion criteria (1 listed)
- Sever heart problem sever demeanor alcoholism drug problems
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 |
|---|---|---|
| NeurorehabilitationAlso: Rob groupNeurorehabilitation with soft exsoskeleton robotic 3-week-long | Other | Robotic |
| PhysiotherapyAlso: Controll groumPhysiotherapy 3-week-long | Other | Controll |
Primary outcome
Qualiti of life measured by Barthel index
Time frame: 3 weeks
quetionnaire
gait/functional test
Time frame: 3 weeks
6 minute walk test (m)
gait/functional test
Time frame: 3 weeks
10 m walk test (m/s)
balance test
Time frame: 3 weeks
Berg balance test
postural control test
Time frame: 3 weeks
posturography
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 3 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 Neurorehabilitation and Physiotherapy in people with Stroke, Acute and Stroke, Ischemic, 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: finished, as of the sponsor's last update on 3 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?
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?
Qualiti of life measured by Barthel index (time frame: 3 weeks). The study lists 5 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 3 Aug 2023.