Sensorimotor Arm Rehabilitation After Stroke

Stroke Clinical Trial

— TAB-APP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590988
• Other study ID #: TAB-APP
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: March 2024

Study information

• Verified date: November 2022
• Source: BDH-Klinik Hessisch Oldendorf
• Contact: Simone B Schmidt, Dr.
• Phone: +49 5152 781 215
• Email: si.schmidt[@]nkho.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Other:
• Tablet-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.
• ergotherapeutic 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.

Locations

Country	Name	City	State
Germany	Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf	Hessisch Oldendorf	Lower Saxony

Sponsors (2)

Lead Sponsor	Collaborator
BDH-Klinik Hessisch Oldendorf	Gottfried Wilhelm Leibniz Universität Hannover

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of functional connectivity of the motor system	measured by differences between resting state functional magnetic resonance imaging (fMRI) scans	Pre-test (day 1), Post-test (day 18)
Primary	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.	Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Primary	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.	Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Primary	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)	Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Secondary	Change of functional abilities	measured by the difference of National Institutes of Health Stroke Scale (NIHSS)	Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Secondary	Change of activities of daily living	measured by the difference of Barthel-Index (BI)	Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Secondary	Change of hand strength	Hand strength is measured with a KERN MAP digital hand force gauge. The change of strength (in kg) is calculated.	Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Secondary	Change of selective motor control after a stroke	measured by the difference of the values of the "Fugl-Meyer-Test" (FMT)	Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)