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临床试验/NCT05590988
NCT05590988
已完成
不适用

Sensorimotor Arm Rehabilitation After Stroke Using Tablet-based Bimanual Coordination Training

BDH-Klinik Hessisch Oldendorf2 个研究点 分布在 1 个国家目标入组 40 人2022年10月7日

概览

阶段
不适用
干预措施
Tablet-based training
疾病 / 适应症
Stroke
发起方
BDH-Klinik Hessisch Oldendorf
入组人数
40
试验地点
2
主要终点
Change of the hand/arm motor skills (unilateral)
状态
已完成
最后更新
12天前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2022年10月7日
结束日期
2026年3月15日
最后更新
12天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
BDH-Klinik Hessisch Oldendorf
责任方
Sponsor

入排标准

入选标准

  • 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)

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: Tablet-based training

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).

干预措施: ergotherapeutic training

结局指标

主要结局

Change of the hand/arm motor skills (unilateral)

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

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

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

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

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

measured by the difference in activity index (calculated from acceleration, movement amplitude and movement frequency during the use of the tablet game)

次要结局

  • Change of functional abilities(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))
  • Change of activities of daily living(Pre-test (day 1), Post-test (day 18), Follow-Up (day 25))

研究点 (2)

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