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临床试验/NCT05662878
NCT05662878已完成不适用

Evaluation of Hand Strength and Spasticity in Hemiplegic Patients Using Hand-Finger Robot Device

Afyonkarahisar Health Sciences University1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2022年10月15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
161
试验地点
1
主要终点
Hand and Finger Grip Strength Assessment

研究概览

简要总结

The aim in this study is to evaluate spasticity and hand grip strength with a finger hand robot in the Turkish population.

详细描述

Spasticity has been defined as "irregular sensorimotor control resulting from upper motor neuron lesion manifesting as intermittent or sustained involuntary activation of muscles".

The commonly used tools in the evaluation of spasticity are subjective clinical scales, including Ashworth Scale (AS), Modified AS (MAS), Tardieu Scale (TS), Modified TS (MTS), and Tone Assessment Scale (TAS). Current scales are based on the clinician's perception of the patient assessing spasticity through their perceptions, experience, and training over the years. An objective measure of spasticity is required, and the development of robot-based systems for this purpose can help clinicians objectify their assessment.

It has been widely shown that robotic systems can be useful in the rehabilitation of adults and children with brain damage. In addition, these systems can be used to assess upper extremity function during treatment.

The aim in this study is to evaluate spasticity and hand grip strength with a finger hand robot in the Turkish population.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hemiplegic patients with sufficient cognitive and language skills to follow instructions will be included in the study.

排除标准

  • Uncooperative Patient
  • Having a skin ulcer on the hand,
  • Patients with contractures of the hand fingers will be excluded.

结局指标

主要结局

Hand and Finger Grip Strength Assessment

时间窗: 2022.12-2023.1

Grip strength will be evaluated with the Jamar hydraulic hand dynamometer. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg. Finger grip strength will be evaluated with the "Jamar Digital Pinchmeter". Patients will be placed in the sitting position with the wrist in 90° flexion and the forearm in the neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg. The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg. Higher scores means better grip strength.

Assessment with Amadeo Device

时间窗: 2022.12-2023.1

Amadeo (Tyromotion, Graz, Austria) is an end-effector device designed for the hand and is one of the very few options currently available on the commercial market. It is a device that is attached to the forearm with its groove-shaped structure and to the fingers with the support of magnets using bandages. The device performs flexion and extension movements of the fingers. It moves the fingers of the patients in the patterns defined in the software of the device. It provides training with passive, assistive and active movements that are ideal for use in all phases of neurological rehabilitation. It was planned to measure finger ROM, muscle strength and spasticity with Amadeo device.

Spasticity Evaluation

时间窗: 2022.12-2023.1

It was planned to evaluate spasticity with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 4 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in flexion and extension.

Neurophysiological Evaluation

时间窗: 2022.12-2023.1

Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient was defined as 6 stages. According to this staging, the lowest stage; stage 1 (flask, the stage without voluntary movement), the highest stage was determined as stage 6 (stage with isolated joint movement). In Brunnstrom staging, the hand, upper extremity, and lower extremity are evaluated separately.

Muscle Power Assessment (MRC Scale)

时间窗: 2022.12-2023.1

The MRC is a scale for muscle strength that ranges from 0 to 5, relative to the maximum expected for a given muscle.

The Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

时间窗: 2022.12-2023.1

The Fugl-Meyer Assessment Scale was developed to quantitatively evaluate sensorimotor recovery after stroke. It is based on Brunnstrom motor recovery stages. Turkish validity and reliability study was conducted.

次要结局

未报告次要终点

研究者

发起方
Afyonkarahisar Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevda Adar

Principal Investigator

Afyonkarahisar Health Sciences University

研究点 (1)

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