Sensorimotor Arm Rehabilitation After Stroke (TAB-APP)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Hemiparesis
• Intervention / Treatment: Other: Tablet-based training; Other: ergotherapeutic training

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simone B Schmidt, Dr.; Phone Number: +49 5152 781 215; Email: si.schmidt@nkho.de

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: BDH-Klinik Hessisch Oldendorf
• Collaborators: Gottfried Wilhelm Leibniz Universität Hannover
• Investigators: Principal Investigator: Jens D Rollnik, Prof. Dr., BDH-Klinik Hessich Oldendorf

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: TAB-APP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No