跳至主要内容
临床试验/NCT04825405
NCT04825405已完成不适用

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

Anna Olczak2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Anna Olczak
入组人数
29
试验地点
2
主要终点
Frequncy of wrist movement (flexion to extension), cycle#sec

研究概览

简要总结

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.

详细描述

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.).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
42 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • : 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.

排除标准

  • 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.

结局指标

主要结局

Frequncy of wrist movement (flexion to extension), cycle#sec

时间窗: up to 1 week

The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)

Assessment of the grip strength

时间窗: up to 1 week

A manual electronic dynamometer (EH 101) was used for grip strength measurement (kg)

Range of passive movement of the wrist, mm

时间窗: up to 1 week

The Hand Tutor allows measuremnt of the range of passive movement (in mm)

Wrist extension deficit, mm

时间窗: up to 1 week

The Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)

Fingers extension deficit, mm

时间窗: up to 1 week

The Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)

Maximum range of fingers movement

时间窗: up to 1 week

The Hand Tutor allows measuremnt of the maximum range of movement (in mm)

Range of passive movement of the fingers, mm

时间窗: up to 1 week

The Hand Tutor allows measuremnt of the range of fingers passive movement (in mm)

Range of active movement of the fingers, mm

时间窗: up to 1 week

The Hand Tutor allows measuremnt of the range of fingers active movement (in mm)

Wrist flexion deficit, mm

时间窗: up to 1 week

The Hand Tutor allows measuremnt of the wrist flexion deficit, (in mm)

Maximum range of wrist movement

时间窗: up to 1 week

The Hand Tutor allows measuremnt of the maximum range of movement (in mm)

Frequncy of fingers movement (flexion to extension), cycle#sec

时间窗: up to 1 week

The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)

Range of active movement of the wrist, mm

时间窗: up to 1 week

The Hand Tutor allows measuremnt of the range of active movement (in mm)

Fingers flexion deficit, mm

时间窗: up to 1 week

The Hand Tutor allows measuremnt of the fingers flexion deficit, (in mm)

次要结局

未报告次要终点

研究者

发起方
Anna Olczak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anna Olczak

PhD; Senior Specjalit of the Rehabilitation Clinc

Military Institute od Medicine National Research Institute

研究点 (2)

Loading locations...

相似试验

The Use of the Tip Stim Glove Device to Achieve... | 临床试验