StrokeTAB-APPNCT05590988
Sensorimotor Arm Rehabilitation After Stroke
A study testing Tablet-based training and ergotherapeutic training in people with Stroke and Hemiparesis, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
Trial summary
Hemiparesis is a frequently observed symptom of stroke. There are various therapy options that are used in the rehabilitation of patients. Some studies have shown that, in addition to unilateral arm training, bilateral arm training can also lead to positive results in treatment and is a useful addition to therapy. Read more about this study
- Who is it for?
- Ages 36 to 65 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Tablet-based training and ergotherapeutic training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 7 Oct 2022to 15 Mar 2026
- 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 36 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of an ischemic/hemorrhagic stroke
- moderate upper extremity paresis: 30 to 60 cubes in the Box-and-Block Test (BBT)
- sufficient resilience / alertness (active participation possible for at least 30 minutes)
- ability to give consent (written declaration of consent from the patient)
Who cannot join
- Hemianopia and/or neglect
- duration of illness >3 months
- pre-existing hemiparesis
- participation in another clinical trial within the last 30 days
- a pregnancy or breast-feeding period
- contraindications for MRI: claustrophobia; metallic or magnetic implants that contain iron, cobalt or nickel (e.g. pacemakers, brain pacemakers, automatic insulin pumps, electrodes, plates, clips, implanted hearing aids, dental implants, metal endoprostheses, metal parts or metal splinters in the body)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
Hessisch Oldendorf, Lower Saxony, 31840
About this study
Official title: Sensorimotor Arm Rehabilitation After Stroke Using Tablet-based Bimanual Coordination Training
Hemiparesis is a frequently observed symptom of stroke. There are various therapy options that are used in the rehabilitation of patients. Some studies have shown that, in addition to unilateral arm training, bilateral arm training can also lead to positive results in treatment and is a useful addition to therapy. The newly developed app requires the coordination of both arms in certain time sequences and intensities or rhythms and addresses different sensory modalities (visual, auditory and kinesthetic). The aim of the study is to examine whether tablet-based training improves bimanual coordination.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Tablet-based training, ergotherapeutic training
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet-based trainingOther
Each task is performed for one minute, followed by a 2-minute break. After the task has been performed three times, there is a 5-minute break. The training block is then carried out twice more. This means that three "blocks" are carried out for each therapy unit.
ergotherapeutic trainingOther
A task is performed for one minute at a time, followed by a 2-minute break. Once three rounds have been completed, there is a 5-minute break. As in the intervention group, there are a total of three training blocks.
| Study group | Role | What they receive |
|---|---|---|
| Tablet | Experimental | The intervention group trained bimanual coordination once a day for about 31 minutes on a total of ten days using a tablet game. A ball is to be moved on a circular line. Receives: Other: Tablet-based training |
| Aximo | Active comparator | The patients in the control group receive an ergotherapeutic therapy unit once a day for the same length of time (approx. 31 minutes) for a total of ten days, in which they train unilaterally. In this therapy unit, the control group uses the "Aximo". This is a comb stand and so-called "rolls" with which plugging tasks can be practiced. The patients should push the rolls into the stand fields with the affected hand. With the plug-in game, the patients can complete different tasks that challenge and train their hand-eye coordination, their fine motor skills and their ability to grasp things (e.g. following a specific pattern based on a template or putting colors in a specific order). Receives: Other: ergotherapeutic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the hand/arm motor skills (unilateral)
measured by the difference in moving wooden cubes in the Box-and-Block Test (BBT) The BBT measures unilateral gross manual dexterity. The patient has to move as many individual cubes as possible from one side of the box over a partition to the other within one minute. The test takes place in a seated position and is performed sequentially with the non-impaired hand and the affected hand. The number of cubes transported for each side is evaluated.
Measured: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Changes in bimanual coordination 1
measured by the difference in moving wooden cubes in the modified Box-and-Block Test (mBBT) For this, a modified box with three compartments and two partitions is used. The task is to take a cube in one hand, pass it to the other hand over the first partition and then transport it over the second partition to the outer compartment. The dice are then counted in the outer compartment. The dice that fall from one hand to the other in the middle compartment are counted separately. The task is performed twice, starting with the unimpaired hand in the first run and with the impaired hand in the second run. The subject has one minute per round to transport as many cubes as possible to the outer compartment.
Measured: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Changes in bimanual coordination 2
measured by the difference in activity index (calculated from acceleration, movement amplitude and movement frequency during the use of the tablet game)
Measured: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Secondary outcomes (4)
Change of functional abilities
measured by the difference of National Institutes of Health Stroke Scale (NIHSS)
Measured: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Change of activities of daily living
measured by the difference of Barthel-Index (BI)
Measured: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Change of hand strength
Hand strength is measured with a KERN MAP digital hand force gauge. The change of strength (in kg) is calculated.
Measured: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Change of selective motor control after a stroke
measured by the difference of the values of the "Fugl-Meyer-Test" (FMT)
Measured: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start7 Oct 2022
- Primary completion19 Aug 2024
- Study completion15 Mar 2026
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- BDH-Klinik Hessisch Oldendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Gottfried Wilhelm Leibniz Universität Hannover
- Responsible party
- Sponsor
- Investigators
- Jens D Rollnik, Prof. Dr., Principal investigator, BDH-Klinik Hessich Oldendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590988
- Sponsor's protocol ID
- TAB-APP
- Acronym
- TAB-APP
- Status last verified
- Apr 2026
- First submitted
- 13 Oct 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang TH, Boltzmann M, Jenner SB, Rollnik JD, Schmitz G, Effenberg AO. A Novel Bilateral Upper Limb Training Method for Stroke Rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2025;33:4184-4195. doi: 10.1109/TNSRE.2025.3614559.
PubMed 41021944
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Arm Rehabilitation After Stroke Using Tablet-based Bimanual Coordination Training
- ClinicalTrials.gov ID
- NCT05590988
- Acronym / sponsor ID
- TAB-APP / TAB-APP
- Conditions
- Stroke, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BDH-Klinik Hessisch OldendorfUniversity, hospital or other
- Collaborators
- Gottfried Wilhelm Leibniz Universität Hannover
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 21 Oct 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.
Hemiparesis is a frequently observed symptom of stroke. There are various therapy options that are used in the rehabilitation of patients. Some studies have shown that, in addition to unilateral arm training, bilateral arm training can also lead to positive results in treatment and is a useful addition to therapy. The newly developed app requires the coordination of both arms in certain time sequences and intensities or rhythms and addresses different sensory modalities (visual, auditory and kinesthetic). The aim of the study is to examine whether tablet-based training improves bimanual coordination.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet | Experimental | Other: Tablet-based trainingThe intervention group trained bimanual coordination once a day for about 31 minutes on a total of ten days using a tablet game. A ball is to be moved on a circular line. |
| Aximo | Active comparator | Other: ergotherapeutic trainingThe patients in the control group receive an ergotherapeutic therapy unit once a day for the same length of time (approx. 31 minutes) for a total of ten days, in which they train unilaterally. In this therapy unit, the control group uses the "Aximo". This is a comb stand and so-called "rolls" with which plugging tasks can be practiced. The patients should push the rolls into the stand fields with the affected hand. With the plug-in game, the patients can complete different tasks that challenge and train their hand-eye coordination, their fine motor skills and their ability to grasp things (e.g. following a specific pattern based on a template or putting colors in a specific order). |
Who may qualify
- Ages
- 36 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of an ischemic/hemorrhagic stroke
- moderate upper extremity paresis: 30 to 60 cubes in the Box-and-Block Test (BBT)
- sufficient resilience / alertness (active participation possible for at least 30 minutes)
- ability to give consent (written declaration of consent from the patient)
Key exclusion criteria (6 listed)
- Hemianopia and/or neglect
- duration of illness >3 months
- pre-existing hemiparesis
- participation in another clinical trial within the last 30 days
- a pregnancy or breast-feeding period
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 |
|---|---|---|
| Tablet-based trainingEach task is performed for one minute, followed by a 2-minute break. After the task has been performed three times, there is a 5-minute break. The training block is then carried out twice more. This means that three "blocks" are carried out for each therapy unit. | Other | Tablet |
| ergotherapeutic trainingA task is performed for one minute at a time, followed by a 2-minute break. Once three rounds have been completed, there is a 5-minute break. As in the intervention group, there are a total of three training blocks. | Other | Aximo |
Primary outcome
Change of the hand/arm motor skills (unilateral)
Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
measured by the difference in moving wooden cubes in the Box-and-Block Test (BBT) The BBT measures unilateral gross manual dexterity. The patient has to move as many individual cubes as possible from one side of the box over a partition to the other within one minute. The test takes place in a seated position and is performed sequentially with the non-impaired hand and the affected hand. The number of cubes transported for each side is evaluated.
Changes in bimanual coordination 1
Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
measured by the difference in moving wooden cubes in the modified Box-and-Block Test (mBBT) For this, a modified box with three compartments and two partitions is used. The task is to take a cube in one hand, pass it to the other hand over the first partition and then transport it over the second partition to the outer compartment. The dice are then counted in the outer compartment. The dice that fall from one hand to the other in the middle compartment are counted separately. The task is performed twice, starting with the unimpaired hand in the first run and with the impaired hand in the second run. The subject has one minute per round to transport as many cubes as possible to the outer compartment.
Changes in bimanual coordination 2
Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
measured by the difference in activity index (calculated from acceleration, movement amplitude and movement frequency during the use of the tablet game)
4 secondary outcomes
Change of functional abilities
Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Change of activities of daily living
Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Change of hand strength
Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Change of selective motor control after a stroke
Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
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 20 Apr 2026.
- Derived from this study: PubMed 41021944Hwang TH, Boltzmann M, Jenner SB, Rollnik JD, Schmitz G, Effenberg AO. A Novel Bilateral Upper Limb Training Method for Stroke Rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2025;33:4184-4195. doi: 10.1109/TNSRE.2025.3614559.
- 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.
Jens D Rollnik, Prof. Dr. principal investigator
BDH-Klinik Hessich Oldendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet-based training and ergotherapeutic training in people with Stroke and Hemiparesis, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
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 4 inclusion and 6 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 20 Apr 2026. 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 Germany. 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?
Change of the hand/arm motor skills (unilateral) (time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)). The study lists 3 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 NCT05590988, 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 20 Apr 2026.