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临床试验/NCT05194501
NCT05194501已完成不适用

EVALUATION OF THE FUNCTIONAL STATUS OF THE "UNAFFECTED" HAND IN HEMIPLEGIC PATIENTS

Ufuk University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年3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
90
试验地点
1
主要终点
The Lawton Instrumental Activities of Daily Living Scale (Lawton-IADL)

研究概览

简要总结

The primary aim of our study is to evaluate the functional status of the unaffected hand in hemiplegic patients. The secondary aims are to compare the functional states of the unaffected hand between right and left hemiplegias, and to evaluate the relationships between the functional status of the unaffected hand and the healing phase of the hemiplegic side and activities of daily living.

This cross-sectional study included 30 right hemiplegic and 30 left hemiplegic patients with a history of ischemic cerebrovascular accident (CVA) in the last 1 year and 30 healthy volunteers as a control group.

Participants' data on age, gender, height, weight, comorbidities, time after stroke, and affected body half were recorded. In the patient group, the stages for the upper extremity and hand were evaluated according to the Brunnstrom recovery stages. Afterwards, the participants' hand grip strengths were evaluated with a Jamar type hand dynamometer, pinch strengths with a pinchmeter, and hand dexerity with the Nine Hole Peg Test (NHPT). Evaluations were made in the unaffected hand in the patient groups and in both hands in the control group. The Lawton Instrumental Activities of Daily Living Scale (Lawton-IADL) and the Functional Independence Measure (FIM) were applied to the patient groups.

研究设计

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

入排标准

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

入选标准

  • This cross-sectional study included 30 right hemiplegic and 30 left hemiplegic patients with a history of ischemic cerebrovascular accident (CVA) in the last 1 year and 30 healthy volunteers as a control group. All patients and healthy volunteers were right hand dominant.

排除标准

  • Patients with a history of CVA in the last 1 month, bilateral hemispheric ischemic lesion, moderate/severe cognitive impairment, aphasia, neglect, and patients/healthy volunteers with severe systemic, inflammatory, degenerative and neurological diseases that may lead to loss of hand functions, a history of surgery or trauma in the upper extremity in the last 3 months, and younger than 18 years of age were excluded.

结局指标

主要结局

The Lawton Instrumental Activities of Daily Living Scale (Lawton-IADL)

时间窗: 6 month

The Lawton Instrumental Activities of Daily Living Scale (Lawton-IADL): Lawton-IADL scale is a scale consisting of eight questions questioning activities use a phone, food preparation, shopping, housekeeping, laundry, use of public transportation, managing self-medication, and handling finances. Each question is scored as 0 (can not perform or can partially perform) or 1 (can perform) \[5\]. The total score ranges from 0 (low functionality, dependent) to 8 (high functionality, independent). The Turkish validity and reliability study of the scale was conducted by Işık et al. in 2020.

The Functional Independence Measure (FIM)

时间窗: 6 month

The Functional Independence Measure (FIM): FIM is an 18-item scale that evaluates the degree of independence of the individual in basic physical and cognitive activities in daily life. It has two main sections in which physical/motor function (13 questions) and cognitive function (5 questions) are evaluated. The part of physical/motor function consists of 4 sub-sections in which different activities \[self-care performance (eating, grooming, bathing, upper dressing, lower dressing, toileting), sphincter control, transfers, locomotion\] are evaluated. The part of cognitive function consists of 2 sub-sections in which communication and social-cognition are evaluated. Each item is scored from 1 to 7, with 'level 1' representing full assistance and 'level 7' being complete independence. The higher the total score, the higher the level of independence. The Turkish adaptation study of the scale was carried out in 2001 by Küçükdeveci et al.

The Nine Hole Peg Test (NHPT)

时间窗: 6 month

The Nine Hole Peg Test (NHPT): Hand dexerities were evaluated with the NHPT available in our clinic. This test is an assembly consisting of a square platform and storage box. There are nine holes in the square-shaped area and nine cylinders suitable for these holes. The patients are asked to take the 9 cylinders one by one from the storage box as quickly as possible, place them into the holes, and place them back in the storage box one by one after all the cylinders have been placed. Meanwhile, the total time is measured in seconds with the chronometer. Less time indicates better hand dexterity.

Hand grip and pinch strengths

时间窗: 6 month

Hand grip and pinch strengths: Hand grip strengths and tip pinch strengths were measured using a Jamar type hand dynamometer and pinchmeter available in our clinic. The measurement of hand grip strengths were made with shoulders in adduction and neutral rotation, elbows in 90 degrees flexion, forearms and wrists in neutral position. Tip pinch strengths were measured by squeezing the pinchmeter between the thumb and forefinger \[12\]. Participants were asked to take a deep breath and grasp with maximal force while exhaling. The measurements were repeated three times with an interval of five minutes, and the average of the values was taken as the basis for the analyses.

次要结局

未报告次要终点

研究者

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

Elzem Bolkan Günaydın

Lecturer Doctor

Ufuk University

研究点 (1)

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