Sensorimotor Arm Rehabilitation After Stroke

Not Applicable

Recruiting

• Conditions: Stroke; Hemiparesis

• Registration Number: NCT05590988
• Lead Sponsor: BDH-Klinik Hessisch Oldendorf

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-07
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-21
• Primary Completion: 2024-06-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of the hand/arm motor skills (unilateral)	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	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	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 Outcome Measures

Name	Time	Method
Change of selective motor control after a stroke	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)
Change of activities of daily living	Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)	measured by the difference of Barthel-Index (BI)
Change of functional abilities	Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)	measured by the difference of National Institutes of Health Stroke Scale (NIHSS)
Change of hand strength	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.

Trial Locations

Locations (1)

Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf; 🇩🇪 Hessisch Oldendorf, Lower Saxony, Germany