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Completed

NCT Number: NCT05590988

Sensorimotor Arm Rehabilitation After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

36 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf

Hessisch Oldendorf, Lower Saxony, 31840, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Tablet-based training

Other

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 training

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

Secondary outcomes

  1. Change of functional abilities

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

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

  2. Change of activities of daily living

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

    measured by the difference of Barthel-Index (BI)

  3. Change of hand strength

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

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

  4. Change of selective motor control after a stroke

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

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

Other outcomes

  1. Change of functional connectivity of the motor system

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

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

Sponsors and collaborators

Lead sponsor

BDH-Klinik Hessisch Oldendorf

Other

Collaborators

  • Gottfried Wilhelm Leibniz Universität Hannover

Registry information

Official study title

Sensorimotor Arm Rehabilitation After Stroke Using Tablet-based Bimanual Coordination Training

Acronym: TAB-APP

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Oct 21, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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