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临床试验/NCT04013750
NCT04013750Unknown不适用

Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Functions of Stroke Patients With Right/Left Hemisphere Damage: Single Blind Randomized Controlled Trial

Istanbul University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2018年1月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Box-Block Test

研究概览

简要总结

The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage. A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale.

详细描述

For the rehabilitation of the paretic upper extremity, the use of constraint induced movement therapy and the use of modified constraint induced movement therapy are the most effective treatment strategies. The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage.

A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. 10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale. Wilcoxon Signed Ranks test and Friedman test were used for intragroup comparison of data and Kruskal-Wallis test was used to compare data between groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Patients in subacute and chronic period (3 months after stroke)
  • Modified Ashworth scale in the hemiplegic arm with 3 or more spasticity
  • No pain in the hemiplegic arm
  • MMSE 20 and above
  • Without major medical problems
  • No previous stroke history
  • Adequate stability to walk when healthy arm is immobilized
  • Active 20 degrees wrist extension and 10 degrees interphalangeal and metacarpophalangeal extension (these movements should be repeated 3 times in 1 minute)

排除标准

  • Bilateral stroke or brainstem affected
  • Active 20-degree wrist extension and 10-degree interphalangeal and metacarpophalangeal extension
  • Global aphasia or cognitive disorders that may affect understanding of test instructions
  • Patients with major medical problems that may affect participation
  • Existence of neglect

结局指标

主要结局

Box-Block Test

时间窗: Patients were examined 3 months after baseline

Box-Block Test

exercise assessment parameters-cubes lined

时间窗: Patients were examined 3 months after baseline

cubes lined in 30 seconds

exercise assessment parameters-card turned

时间窗: Patients were examined 3 months after baseline

card turned in 30 seconds

exercise assessment parameters-object gripped

时间窗: Patients were examined 3 months after baseline

object gripped in 30 seconds

Motor Activity Log

时间窗: Patients were examined 3 months after baseline

Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.

exercise assessment parameters-water

时间窗: Patients were examined 3 months after baseline

time it takes to grip and carry a water filled glass to their mouth and putting it back

Fugl-Meyer Motor Assessment Scale

时间窗: Patients were examined 3 months after baseline

The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.

次要结局

  • Stroke Impact Scale(Patients were examined 3 months after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cansin Medin Ceylan

assistant doctor

Istanbul University

研究点 (2)

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