StrokeNCT03736200
Neuro-rehabilitation Training Effects on Motion and Quality of Life After Acute Stroke and Post Stroke
A study testing Exergaming group, Physiotherapy and Exergaming group 2/day in people with Stroke, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
High intensity motion improves motor functions and quality of life in a neurologist. The investigators want to improve the clinical condition and quality of life of post-STROKE participants with a special sensory motor and visual motor agility therapy. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Exergaming group, Physiotherapy and Exergaming group 2/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2018to 1 Nov 2019
- 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 2 weeks
Who cannot join
- Sever heart problem
- sever demeanor
- alcoholism
- drug problems
Trial locations and contacts
1 site in 1 country.
About this study
High intensity motion improves motor functions and quality of life in a neurologist. The investigators want to improve the clinical condition and quality of life of post-STROKE participants with a special sensory motor and visual motor agility therapy.
Read the detailed description
High intensity motion improves engine function and quality of life in a neurologist. With special sensory motor and visual motility, investigaters want to improve the clinical condition and quality of life of STROKE participants.
The investigaters randomly select participants who only perform the rehabilitation treatment have performed. The other group that will receive the study's control group will receive the traditional rehabilitation physiotherapy treatment.
The investigaters assess the condition and quality of life of the patients. (EQ5-D, Barthel index, MRS test) The ivestigaters examine the functional movement and equilibrium variables of patients. (6MWT, Berg balance test, postgraduation) After that, participants are undergoing a 4-week intensive rehabilitation treatment. All participants are in post stroke.
Primary Hypothesis will be changes in life-quality tests (EQ5-D, Barthel index, MRS test). Functional tests show progress 6MWT, Berg balance test and postural control testing with posturography. The results are compared and evaluated among the groups.
The expected hypothesis is that visual and acoustic stimulation produces a better physical state at higher intensity.
- Conditions
- Stroke
- Being tested
- Exergaming group, Physiotherapy, Exergaming group 2/day
- Keywords
- balance, movement, exergaming, posture, quality of life, gait
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergaming groupOther
Also called EXE group
Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (1/day)
PhysiotherapyOther
Also called Physio group
Physiotherapy 4-week-long.
Exergaming group 2/dayOther
Also called EXE2 group
Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (2/day)
| Study group | Role | What they receive |
|---|---|---|
| Exergaming 1/day | Active comparator | Post stroke group that received 4 weeks of intensive therapy. (1/day) Receives: Other: Exergaming group |
| physiotherapy | Active comparator | Post stroke group that received 4 weeks of traditional physiotherapy. Receives: Other: Physiotherapy |
| Exergaming 2/day | Active comparator | Post stroke group that received 4 weeks of intensive therapy. (2/day) Receives: Other: Exergaming group 2/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measured by Barthel index
questionnaire
Measured: 4 weeks
gait / functional test
6 minute walk test (m)
Measured: 4 weeks
balance test
Berg balance test
Measured: 4 weeks
postrural control test
posturography (mm)
Measured: 4 weeks
Quality of life measured by EQ5-D scale
questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Sep 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 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
- NCT03736200
- Sponsor's protocol ID
- IKEB008/2018
- Status last verified
- Sep 2018
- First submitted
- 1 Nov 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tollar J, Nagy F, Csutoras B, Prontvai N, Nagy Z, Torok K, Blenyesi E, Vajda Z, Farkas D, Toth BE, Repa I, Moizs M, Sipos D, Kedves A, Kovacs A, Hortobagyi T. High Frequency and Intensity Rehabilitation in 641 Subacute Ischemic Stroke Patients. Arch Phys Med Rehabil. 2021 Jan;102(1):9-18. doi: 10.1016/j.apmr.2020.07.012. Epub 2020 Aug 27.
PubMed 32861668
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-rehabilitation Training Effects on Motion and Quality of Life After Acute Stroke and Post Stroke
- ClinicalTrials.gov ID
- NCT03736200
- Acronym / sponsor ID
- IKEB008/2018
- Conditions
- Stroke
- Keywords
- balance, movement, exergaming, posture, quality of life, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 9 Nov 2018 (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.
High intensity motion improves motor functions and quality of life in a neurologist. The investigators want to improve the clinical condition and quality of life of post-STROKE participants with a special sensory motor and visual motor agility therapy.
Detailed description
High intensity motion improves engine function and quality of life in a neurologist. With special sensory motor and visual motility, investigaters want to improve the clinical condition and quality of life of STROKE participants.
The investigaters randomly select participants who only perform the rehabilitation treatment have performed. The other group that will receive the study's control group will receive the traditional rehabilitation physiotherapy treatment.
The investigaters assess the condition and quality of life of the patients. (EQ5-D, Barthel index, MRS test) The ivestigaters examine the functional movement and equilibrium variables of patients. (6MWT, Berg balance test, postgraduation) After that, participants are undergoing a 4-week intensive rehabilitation treatment. All participants are in post stroke.
Primary Hypothesis will be changes in life-quality tests (EQ5-D, Barthel index, MRS test). Functional tests show progress 6MWT, Berg balance test and postural control testing with posturography. The results are compared and evaluated among the groups.
The expected hypothesis is that visual and acoustic stimulation produces a better physical state at higher intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exergaming 1/day | Active comparator | Other: Exergaming groupPost stroke group that received 4 weeks of intensive therapy. (1/day) |
| physiotherapy | Active comparator | Other: PhysiotherapyPost stroke group that received 4 weeks of traditional physiotherapy. |
| Exergaming 2/day | Active comparator | Other: Exergaming group 2/dayPost stroke group that received 4 weeks of intensive therapy. (2/day) |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- post stroke
- 6MWT : 120>
- minimum after stroke 2 weeks
Key exclusion criteria (4 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 |
|---|---|---|
| Exergaming groupAlso: EXE groupNeurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (1/day) | Other | Exergaming 1/day |
| PhysiotherapyAlso: Physio groupPhysiotherapy 4-week-long. | Other | physiotherapy |
| Exergaming group 2/dayAlso: EXE2 groupNeurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (2/day) | Other | Exergaming 2/day |
Primary outcome
Quality of life measured by Barthel index
Time frame: 4 weeks
questionnaire
gait / functional test
Time frame: 4 weeks
6 minute walk test (m)
balance test
Time frame: 4 weeks
Berg balance test
postrural control test
Time frame: 4 weeks
posturography (mm)
Quality of life measured by EQ5-D scale
Time frame: 4 weeks
questionnaire
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 28 Apr 2020.
- Derived from this study: PubMed 32861668Tollar J, Nagy F, Csutoras B, Prontvai N, Nagy Z, Torok K, Blenyesi E, Vajda Z, Farkas D, Toth BE, Repa I, Moizs M, Sipos D, Kedves A, Kovacs A, Hortobagyi T. High Frequency and Intensity Rehabilitation in 641 Subacute Ischemic Stroke Patients. Arch Phys Med Rehabil. 2021 Jan;102(1):9-18. doi: 10.1016/j.apmr.2020.07.012. Epub 2020 Aug 27.
- 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 Exergaming group, Physiotherapy and Exergaming group 2/day 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 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 28 Apr 2020. 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?
Quality of life measured by Barthel index (time frame: 4 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?
On the ClinicalTrials.gov record for NCT03736200, which also lists 1 linked publication.
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 28 Apr 2020.