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The Use of the Tip Stim Glove Device to Achieve Coordinated Movement of the Human Hand

2021年3月30日 更新者:Anna Olczak

Influence of the Tested Position and the Use of the TipStim Glove Device on the Improvement of the Hand Motor Coordination After Stroke

The study was to evaluate the use of the Tip Stim device to achieve coordinated movement and grip force in stroke patients under conditions of active and passive stabilization of the trunk.

研究概览

详细说明

To test the effectiveness of the Tip Stim device, each patient received (alternating) both the experimental and control treatments in a specific sequence to assess the coordination of human hand movement and the grip strength. The first therapy with the use of Tip Stim parameters (Ratio current time to pause time: 2 sec :5 sec; Ramp (rise time impulse): 0,3 sec; Frequency: 20 Hz; Pulse width: 300 µs). Another session (putting on the glove without setting any parameters) took place after a week (time to mute the effects of the intervention). The duration of each therapy session is 60 minutes. After the first therapeutic session and after a week, the parameters of movement coordination and hand grip were examined. The study of motor coordination and grip strength was performed in two different starting positions: sitting (no stabilization) (fig. 1) and lying (with stabilization) (fig. 2), and with a different position of the examined upper limb. During the first examination, the subject sat on a treatment table, feet resting on the floor. Upper limb examined in adduction, with bent elbow joint in the intermediate position between pronation and supination of the forearm. In the supine examination, the upper limb was stabilized against the subject's body (adduction in the shoulder joint, flexion in the elbow joint in an intermediate position). In each of the starting positions, first after putting on the glove, the range of passive motion in the radial-wrist joint (flexion and extension) and fingers (global flexion and extension) was measured, then the active movement was measured, in the sequence as above. Eventually, they were asked to make movements as quickly and as fully as possible. Measurement of the grip force with a dynamometer was performed in both analyzed starting positions after testing the ranges of motion and speed/frequency.

The Hand Tutor device and the EH 101 electronic hand dynamometer measuring the strength of the handgrip (measurement error 0.5 kg / 1 lb) were used to test the parameters of motor coordination and grip strength. The Hand Tutor is a device with a rehabilitation program and the ability to measure the range of passive and active movement, deficits of movement (error of measurement, 5 - 10 mm) as well as the speed/frequency of movement (error of measurement, 0,5 cycle/sec.).

研究类型

介入性

注册 (实际的)

29

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Masovian District
      • Warsaw、Masovian District、波兰、04-141
        • Anna Olczak

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

42年 至 89年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:: 1) patients with hemiparesis after 5 to 7 weeks after stroke; 2) no severe deficits in communication, memory, or understanding what can impede proper measurement performance; 3) at least 40 years of age; 4) maximum 89 years of age.

-

Exclusion Criteria:1) stroke up to two weeks after the episode, 2) acute polyneuropathy and damage to peripheral nerves, 3) lack of trunk stability, 4) no wrist and hand movement, 5) hypersensitivity to electrical stimulation, 6) metal implants in the hand, cardiac dysfunction, epilepsy, 7) decorations on the fingers, 8) high or very low blood pressure, 9) dizziness , malaise of the respondents.

-

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:The use of the active Tip Stim device to achieve coordinated of the hand.
Influence of the tested position and the use of the active TipStim Glove device on the improvement of motor coordination and grip force in patients after a stroke.
The next therapy with the use of Tip Stim took place after a week. The duration of each therapy session was 60 minutes. After the first therapy session and after a week, the parameters of movement coordination and handgrip were examined. The study of motor coordination and grip strength was performed in two different starting positions: sitting (no stabilization) and lying (with stabilization), and with a different position of the examined upper limb. The upper limb was examined in adduction, with the bent elbow joint in the intermediate position of the forearm. In each of the starting positions, first, the range of passive motion in the wrist joint (flexion and extension) and fingers (global flexion and extension) was measured, then the active movement was measured, in the sequence as above. Patients were asked to make movements as quickly and as fully as possible. Measurement of the grip force was performed after testing the ranges of motion and speed/frequency.
其他名称:
  • hand motor coordination in a supine position after use TipStim Glove
安慰剂比较:The use of the passive Tip Stim device to achieve coordinated of the hand.
Influence of the tested position and the use of the passive TipStim Glove device on the improvement of motor coordination and grip force in patients after a stroke.
The next therapy with the use of Tip Stim took place after a week. The duration of each therapy session was 60 minutes. After the first therapy session and after a week, the parameters of movement coordination and handgrip were examined. The study of motor coordination and grip strength was performed in two different starting positions: sitting (no stabilization) and lying (with stabilization), and with a different position of the examined upper limb. The upper limb was examined in adduction, with the bent elbow joint in the intermediate position of the forearm. In each of the starting positions, first, the range of passive motion in the wrist joint (flexion and extension) and fingers (global flexion and extension) was measured, then the active movement was measured, in the sequence as above. Patients were asked to make movements as quickly and as fully as possible. Measurement of the grip force was performed after testing the ranges of motion and speed/frequency.
其他名称:
  • hand motor coordination in a supine position after use TipStim Glove

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Range of passive movement of the wrist, mm
大体时间:up to 1 week
The Hand Tutor allows measuremnt of the range of passive movement (in mm)
up to 1 week
Range of active movement of the wrist, mm
大体时间:up to 1 week
The Hand Tutor allows measuremnt of the range of active movement (in mm)
up to 1 week
Wrist extension deficit, mm
大体时间:up to 1 week
The Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)
up to 1 week
Wrist flexion deficit, mm
大体时间:up to 1 week
The Hand Tutor allows measuremnt of the wrist flexion deficit, (in mm)
up to 1 week
Maximum range of wrist movement
大体时间:up to 1 week
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
up to 1 week
Frequncy of wrist movement (flexion to extension), cycle#sec
大体时间:up to 1 week
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
up to 1 week
Assessment of the grip strength
大体时间:up to 1 week
A manual electronic dynamometer (EH 101) was used for grip strength measurement (kg)
up to 1 week
Range of passive movement of the fingers, mm
大体时间:up to 1 week
The Hand Tutor allows measuremnt of the range of fingers passive movement (in mm)
up to 1 week
Range of active movement of the fingers, mm
大体时间:up to 1 week
The Hand Tutor allows measuremnt of the range of fingers active movement (in mm)
up to 1 week
Fingers extension deficit, mm
大体时间:up to 1 week
The Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)
up to 1 week
Fingers flexion deficit, mm
大体时间:up to 1 week
The Hand Tutor allows measuremnt of the fingers flexion deficit, (in mm)
up to 1 week
Maximum range of fingers movement
大体时间:up to 1 week
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
up to 1 week
Frequncy of fingers movement (flexion to extension), cycle#sec
大体时间:up to 1 week
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
up to 1 week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Anna Olczak, PhD、Military Institute of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年7月10日

初级完成 (实际的)

2020年2月14日

研究完成 (实际的)

2020年2月14日

研究注册日期

首次提交

2021年3月28日

首先提交符合 QC 标准的

2021年3月30日

首次发布 (实际的)

2021年4月1日

研究记录更新

最后更新发布 (实际的)

2021年4月1日

上次提交的符合 QC 标准的更新

2021年3月30日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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