Sensorimotor Arm Rehabilitation After Stroke

NCT ID: NCT05590988

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-07
• Study Completion Date: 2026-03-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tablet-based training

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

ergotherapeutic training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 36 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gottfried Wilhelm Leibniz Universität Hannover

OTHER

Sponsor Role: collaborator

BDH-Klinik Hessisch Oldendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens D Rollnik, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

BDH-Klinik Hessich Oldendorf

Locations

Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf

Hessisch Oldendorf, Lower Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Simone B Schmidt, Dr.

Role: CONTACT

si.schmidt@nkho.de

+49 5152 781 215

Facility Contacts

Simone B Schmidt, Dr.

Role: primary

si.schmidt@nkho.de

0049 5152 781 215

Other Identifiers

TAB-APP

Identifier Type: -

Identifier Source: org_study_id