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临床试验/NCT04782141
NCT04782141已完成不适用

Positioning the Trunk and Upper Limb to Improve the Coordination of the Wrist and Fingers After Stroke

Military Institute od Medicine National Research Institute2 个研究点 分布在 1 个国家目标入组 277 人开始时间: 2019年8月5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
入组人数
277
试验地点
2
主要终点
Range of passive movement of the wrist

研究概览

简要总结

This study investigated how torso and shoulder positioning can help restore coordinated hand movements in stroke patients.

详细描述

Stroke patients and healthy subjects were randomly divided into two different groups and tested in different positions. In study group 1, the exercise test consisted of two motor tasks carried out in two different starting positions: sitting and supine. During the first examination, the subject sat on the therapeutic table (without back support), feet resting on the floor (active stabilization of the trunk and shoulder). The upper limb was examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. In the supine position, the upper limb was held beside the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position; passive stabilization of the trunk and shoulder).

In study group 2, the exercise test again consisted of two motor tasks carried out in two different starting positions: supine with the upper extremity positioned perpendicularly to the trunk (passive stabilization of the trunk, active stabilization of the shoulder), and supine with the upper limb held beside the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position; passive stabilization of the trunk and shoulder).

A manual electronic dynamometer (EH 101) was used for grip strength measurement (error of measurement, 0.5 kg/lb). A Hand Tutor device (composed of a safe and comfortable glove equipped with position and motion sensors, and the Medi Tutor(TM) software) was used to measure the range of passive and active movement (error of measurement, 5 - 10 mm), as well as the speed/frequency of movement (error of measurement, 0,5 cycle/sec.).

First, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured in each position using the Hand Tutor Device. Then the subject made active movements in the same order. Finally, the subject was asked to make moves as quickly and in as full a range as possible. The measurement of grip strength with a dynamometer was performed in each position after the range of motion and speed/frequency tests.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 87 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Study Group 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 20 years of age.

排除标准

  • stroke up to 5 weeks after the episode; 2) epilepsy; 3) lack of trunk stability; 4) no wrist and hand movement; 5) high very low blood pressure; 6) dizziness; 7) malaise
  • Control Group
  • Inclusion Criteria: 1) the control group consisted of subjects free from the upper extremity motor coordination disorders; 2) at least 20 years of age.
  • Exclusion Criteria: 1) history of neurologic or musculoskeletal disorders such as carpal tunnel syndrome, tendonitis, stroke, head injury, or other conditions that could affect their ability to active movement and handgrip; 2) severe deficits in communication, memory, or understanding what can impede proper measurement performance; 3) high very low blood pressure; 4) dizziness; 5) malaise

结局指标

主要结局

Range of passive movement of the wrist

时间窗: up to 10 weeks

The Hand Tutor allows measurements of the range of passive movement of the wrist (in mm).

Range of active movement of the wrist

时间窗: up to 10 week

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

Wrist extension deficit (mm). The extension deficit refers to the difference between passive and active ROM.

时间窗: up to 10 weeks

The Hand Tutor allows measurements of the extension deficit (in mm)

Wrist flexion deficit mm

时间窗: up to 10 weeks

The Hand Tutor allows measurements of the flexion deficit (in mm). The flexion deficit refers to the difference between passive and active ROM.

Wrist maximum range of motion (ROM), mm

时间窗: up to 10 weeks

The Hand Tutor allows measurements of the maximum range of motion (ROM) (in mm), from flexion to extension.

Frequency of wrist movement (flexion to extension), cycles#/sec

时间窗: up to 10 weeks

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

Range of passive movement of the fingers

时间窗: up to 10 weeks

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

Range of active movement of the fingers

时间窗: up to 10 weeks

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

Fingers extension deficit mm

时间窗: up to 10 weeks

The Hand Tutor allows measurements of the extension deficit (in mm). The extension deficit refers to the difference between passive and active ROM.

Fingers maximum range of motion (ROM), mm

时间窗: up to 10 weeks

The Hand Tutor allows measurements of the maximum range of motion (ROM) (in mm), from flexion to extension of each finger.

Frequency of fingers movement (flexion to extension), cycles#/sec

时间窗: up to 10 weeks

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

Fingers flexion deficit mm

时间窗: up to 10 weeks

The Hand Tutor allows measurements of the flexion deficit (in mm). The flexion deficit refers to the difference between passive and active ROM.

Assessment of the grip strength

时间窗: up to 10 weeks

Grip strength, kg (a manusl electronic dynamometr (EH 101) was used for grip strength

次要结局

未报告次要终点

研究者

发起方
Military Institute od Medicine National Research Institute
申办方类型
Other
责任方
Principal 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)

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