Back to resultsSensorimotor Arm Rehabilitation After Stroke (TAB-APP)
Primary Purpose
Stroke, Hemiparesis
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Tablet-based training
ergotherapeutic training
Sponsored by
About this trial
This is an interventional basic science trial for Stroke
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)
Sites / Locations
- Institute for Neurorehabilitation Research, BDH-Clinic Hessich OldendorfRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tablet
Aximo
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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.
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.
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)
Secondary Outcome Measures
Change of functional abilities
measured by the difference of National Institutes of Health Stroke Scale (NIHSS)
Change of activities of daily living
measured by the difference of Barthel-Index (BI)
Change of hand strength
Hand strength is measured with a KERN MAP digital hand force gauge. The change of strength (in kg) is calculated.
Change of selective motor control after a stroke
measured by the difference of the values of the "Fugl-Meyer-Test" (FMT)
Full Information
NCT ID
NCT05590988
First Posted
October 13, 2022
Last Updated
November 4, 2022
Sponsor
BDH-Klinik Hessisch Oldendorf
Collaborators
Gottfried Wilhelm Leibniz Universität Hannover
1. Study Identification
Unique Protocol Identification Number
NCT05590988
Brief Title
Sensorimotor Arm Rehabilitation After Stroke
Acronym
TAB-APP
Official Title
Sensorimotor Arm Rehabilitation After Stroke Using Tablet-based Bimanual Coordination Training
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BDH-Klinik Hessisch Oldendorf
Collaborators
Gottfried Wilhelm Leibniz Universität Hannover
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Results are evaluated by an independent scientists and group assignment is pseudonymised.
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tablet
Arm Type
Experimental
Arm Description
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.
Arm Title
Aximo
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Tablet-based training
Intervention Description
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
Intervention Name(s)
ergotherapeutic training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the hand/arm motor skills (unilateral)
Description
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.
Time Frame
Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Title
Changes in bimanual coordination 1
Description
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.
Time Frame
Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Title
Changes in bimanual coordination 2
Description
measured by the difference in activity index (calculated from acceleration, movement amplitude and movement frequency during the use of the tablet game)
Time Frame
Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Secondary Outcome Measure Information:
Title
Change of functional abilities
Description
measured by the difference of National Institutes of Health Stroke Scale (NIHSS)
Time Frame
Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Title
Change of activities of daily living
Description
measured by the difference of Barthel-Index (BI)
Time Frame
Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Title
Change of hand strength
Description
Hand strength is measured with a KERN MAP digital hand force gauge. The change of strength (in kg) is calculated.
Time Frame
Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Title
Change of selective motor control after a stroke
Description
measured by the difference of the values of the "Fugl-Meyer-Test" (FMT)
Time Frame
Pre-test (day 1), Post-test (day 18), Follow-Up (day 25)
Other Pre-specified Outcome Measures:
Title
Change of functional connectivity of the motor system
Description
measured by differences between resting state functional magnetic resonance imaging (fMRI) scans
Time Frame
Pre-test (day 1), Post-test (day 18)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simone B Schmidt, Dr.
Phone
+49 5152 781 215
Email
si.schmidt@nkho.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens D Rollnik, Prof. Dr.
Organizational Affiliation
BDH-Klinik Hessich Oldendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
City
Hessisch Oldendorf
State/Province
Lower Saxony
ZIP/Postal Code
31840
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone B Schmidt, Dr.
Phone
0049 5152 781 215
Email
si.schmidt@nkho.de
12. IPD Sharing Statement
Plan to Share IPD
No
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Sensorimotor Arm Rehabilitation After Stroke
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