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临床试验/NCT01735877
NCT01735877已完成3 期

Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial

Christian Medical College and Hospital, Ludhiana, India2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months

研究概览

简要总结

Hemi spatial neglect, or the tendency to ignore stimuli originating in a portion of the environment contra lateral to a cerebral lesion, can be a major source of functional handicap after stroke. The currently available treatments for unilateral neglect are scanning training, visual cuing approaches, limb activation strategies, visual imagery, tactile stimulation, prisms and sustained attention training.Mirror therapy improves the hand function in sub-acute stroke.

Hypothesis: To evaluate the effectiveness of Mirror therapy in the management of stroke patients with unilateral neglect.

详细描述

About 30 - 50% of stroke patients are left with considerable residual deficits. The post stroke disabilities are due to loss of locomotion and activities of daily living, cognition and communication skills.Hemispatial neglect has been reported in association with damage to several different cerebral structures in a large-scale distributed neurocognitive network.Mirror therapy improves the hand function in sub-acute stroke. It also helps in the recovery of neglect in stroke patients. But little consensus exists as to whether one treatment is more efficacious than others and many studies fail to document duration of treatment effects or generalization to daily activities. The aim of our study is to evaluate the effectiveness of limb activation with MT and limb activation strategy alone in the management of stroke patients with unilateral neglect and to make the patient functional in activities of daily living.

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

  • 1.All stroke patients with parietal lobe and thalamic lesions
  • Stroke duration: within 48 hours
  • Patients willing to participate in the study
  • MRI/ CT scan showing parietal lobe and thalamic lesion
  • Patients with upper limb weakness

排除标准

  • Stroke duration more than 1 yr
  • Glasgow Coma Scale (GCS) of less than 7
  • Uncooperative patients

结局指标

主要结局

Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months

时间窗: Baseline, 1,3 and 6 months

The SCT consisted of a page containing 52 large stars, 10 short words and 13 letters, randomly positioned, with 56 small stars interspersed. Subjects were instructed to cross out (with a black pen) all the small stars across the page. The tester demonstrated by crossing out the two central stars. The cut off score to establish presence of unilateral visual neglect were: 51 or fewer stars cancelled for SCT. Minimum score: 0 Maximum score: 54 Higher scores: better outcome

Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months

时间窗: Baseline, 1,3 and 6 months

The Line Bisection Test (LBT) consisted of three horizontal black lines, 20 cm long, one to the right, one central and one to the left side of a sheet of white paper (21cms X 30 cms). The patients were asked to find and mark the centre of each line in turn. Errors away from true midline were measured, with leftward errors being given a negative sign, rightward errors a positive sign. We took an absolute value for the change in error. The values for baseline to 1 month were calculated by subtracting baseline values from 1 month values. Then, the mean change was calculated for baseline to 1 month. Similar method was followed for the calculation of mean change in baseline to 3 months and 6 months. The patients responses were similar for the three lines that they marked hence we took the first line for the interpretation. None of the patients had extreme errors like missed marking at 3 and 6 months.

Change From Baseline in Picture Identification Task at 1,3, and 6 Months

时间窗: Baseline, 1,3 and 6 months

PIT consisted of 10 pictures on A4 size paper and patients were asked to identify pictures. More the number of pictures identified, lesser was the neglect.

次要结局

  • Functional Independence Measure(Baseline, 1, 3 and 6 months)
  • Modified Rankin Scale (mRS)(Baseline, 1,3 and 6 months)

研究者

发起方
Christian Medical College and Hospital, Ludhiana, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

jeyarajpandian

Professor

Christian Medical College and Hospital, Ludhiana, India

研究点 (2)

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