ClinicalTrials.gg
CompletedNCT05590988TAB-APPUpdated Apr 20, 2026

Sensorimotor Arm Rehabilitation After Stroke

An interventional study of Tablet-based training and ergotherapeutic training in Stroke and Hemiparesis, sponsored by BDH-Klinik Hessisch Oldendorf. Completed at 1 site in Germany. Open to participants aged 36 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by BDH-Klinik Hessisch Oldendorf · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
36 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 356 studies in Stroke with a site in Germany — 51 open to participants now, 66 under way, 8 of them phase 3. Stroke · Germany.

Enrollment
170th of 222
40 · median 200
Started
2022
with 9 others
No phase
104 of 356
18 open now
Registered
305th of 356
by date

Among the 356 studies in Stroke with a site in Germany, this one is the 170th largest by enrollment of the 222 interventional ones that give a count, is one of 10 that started in 2022, is one of 104 with no phase, and was the 305th registered.

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 40 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Open to participants now

51 of the 356 studies in Stroke with a site in Germany are open now, in 12 countries. Each count lists the studies.

All 51 open studies →

Who these studies take

Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 36 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →
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02

Study 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. 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.

03

Conditions studied

  • Stroke
  • Hemiparesis

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04

Who can participate

Ages eligible
36 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Tablet

    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.

    Other: Tablet-based training

  • Active comparator
    Aximo

    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).

    Other: ergotherapeutic training

Interventions

  • OtherTablet-based training

    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.

  • Otherergotherapeutic training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)

  2. 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.

    Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)

  3. 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)

    Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)

Secondary outcomes

  1. Change of functional abilities

    measured by the difference of National Institutes of Health Stroke Scale (NIHSS)

    Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)

  2. Change of activities of daily living

    measured by the difference of Barthel-Index (BI)

    Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)

  3. Change of hand strength

    Hand strength is measured with a KERN MAP digital hand force gauge. The change of strength (in kg) is calculated.

    Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)

  4. Change of selective motor control after a stroke

    measured by the difference of the values of the "Fugl-Meyer-Test" (FMT)

    Time frame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)

Other outcomes

  1. Change of functional connectivity of the motor system

    measured by differences between resting state functional magnetic resonance imaging (fMRI) scans

    Time frame: Pre-test (day 1), Post-test (day 18)

07

Study locations

1 site
  • Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
    Hessisch Oldendorf, Lower Saxony 31840, Germany
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2022 to primary completion in Aug 2024, 22 months.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 22 months is close to that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2022
First posted
Oct 21, 2022
StartActual
Oct 7, 2022
Primary completionActual
Aug 19, 2024
CompletionActual
Mar 15, 2026
Last update
Apr 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05590988
Lead sponsor
BDH-Klinik Hessisch Oldendorf
Collaborators
Gottfried Wilhelm Leibniz Universität Hannover
Responsible party
Sponsor
First posted
Oct 21, 2022
Start date
Oct 7, 2022
Primary completion
Aug 19, 2024
Completion
Mar 15, 2026
Last update
Apr 20, 2026

Study contacts

Jens D Rollnik, Prof. Dr.
principal investigator · BDH-Klinik Hessich Oldendorf

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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