Sensorimotor Arm Rehabilitation After Stroke

NCT05590988 | Completed

• 1 other identifier: TAB-APP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change of functional abilities

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

• Change of activities of daily living

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

• Change of hand strength

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

• Change of selective motor control after a stroke

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

Other Outcomes (1)

• Change of functional connectivity of the motor system

  Pre-test (day 1), Post-test (day 18)

Study Arms (2)

Tablet

EXPERIMENTAL

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

Aximo

ACTIVE COMPARATOR

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

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.

Tablet

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.

Aximo

Eligibility Criteria

• Age: 36 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• BDH-Klinik Hessisch Oldendorf: lead
• Gottfried Wilhelm Leibniz Universität Hannover: collaborator

Study Sites (1)

Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf

Hessisch Oldendorf, Lower Saxony, 31840, Germany

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

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

Study Officials

• Jens D Rollnik, Prof. Dr.

  BDH-Klinik Hessich Oldendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Results are evaluated by an independent scientists and group assignment is pseudonymised.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 21, 2022
• Study Start: October 7, 2022
• Primary Completion: August 19, 2024
• Study Completion: March 15, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)