Clinical trial NCT05590988: Sensorimotor Arm Rehabilitation After Stroke
Official title: Sensorimotor Arm Rehabilitation After Stroke Using Tablet-based Bimanual Coordination Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Hemiparesis
Lead sponsor: BDH-Klinik Hessisch Oldendorf
Sponsor class: OTHER
Collaborators: name: Gottfried Wilhelm Leibniz Universität Hannover
First posted: 2022-10-21
Enrollment: 36
Sex: ALL
Minimum age (years): 36
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Change of the hand/arm motor skills (unilateral)
timeFrame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
measure: Changes in bimanual coordination 1
timeFrame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
measure: Changes in bimanual coordination 2
timeFrame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Secondary outcomes:
measure: Change of functional abilities
timeFrame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
measure: Change of activities of daily living
timeFrame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
measure: Change of hand strength
timeFrame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
measure: Change of selective motor control after a stroke
timeFrame: Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Other outcomes:
measure: Change of functional connectivity of the motor system
timeFrame: Pre-test (day 1), Post-test (day 18)
Locations:
city: Hessisch Oldendorf
country: Germany
facility: Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
state: Lower Saxony
Study officials:
affiliation: BDH-Klinik Hessich Oldendorf
name: Jens D Rollnik, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: