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临床试验/NCT03584035
NCT03584035已完成不适用

Effects of Sensorimotor Integration Exercises on Balance and Fall Efficacy in Sub-acute Stroke

Mahidol University3 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
3
主要终点
Berg Balance Scale (BBS)

研究概览

简要总结

To study the effect of sensorimotor integration exercises on balance and fall efficacy in sub-acute stroke by performing 18 balance training exercises with three progressive steps.

详细描述

Balance impairment after stroke is significantly correlated with fall risk. To improve balance and reduce fall efficacy, the participants in the study group will be trained by six weeks three progressive steps of sensorimotor integration exercises. Each exercise step will take 30 minutes of a practice session, three sessions per week. Conventional physiotherapy (passive and active exercises and lower extremities strengthening exercises) will be given to the control group. The changes in balance performance and fall efficacy will be measured and compared within and 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)

盲法说明

The outcome assessor will do all assessments (pre and post intervention) without group allocation.

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First episode of sub-acute stroke (from 1 to 26 weeks) referred from physicians
  • Both sexes
  • Age above 20
  • Good cognition (Mini Mental State Examination Scale ≥24)
  • Moderate and moderately severe disability (Modified Rankin Scale- 3 and 4)
  • Impaired balance (BBS <41)

排除标准

  • Recurrent stroke
  • Associated with other neurological conditions (such as Parkinson's disease, Epilepsy, meningitis)
  • Deficits of somatic sensation involving the paretic limb (Fugl-Meyer Assessment - sesation< 1)
  • Lower extremity weight bearing pain (Fugl-Meyer Assessment- pain <1)
  • Low back pain (VAS ≥ 3)
  • Severe visual deficits which cannot be corrected by lens or glasses
  • Symptomatic vestibular disorders (Paroxysmal postural vertigo)
  • Associated serious cardiac disorder

研究组 & 干预措施

Sensory motor integration group

Experimental

Sensory-motor integration exercises with 3 progressive steps, 30 minutes per sessions, 3 sessions per week for 6 weeks.

干预措施: sensory motor integration exercises (Behavioral)

Conventional group

Active Comparator

Conventional exercises include simple passive and active exercises and lower extremities strengthening exercises for balance and ambulation. The exercise session will last 30 minutes for 3 sessions per week. The total intervention period is 6 weeks.

干预措施: conventional physiotherapy (Behavioral)

结局指标

主要结局

Berg Balance Scale (BBS)

时间窗: 6 weeks

14 items to measure static and dynamic balance

次要结局

  • Fall Efficacy Scale(6 weeks)
  • Functional Reach Test(6 weeks)

研究者

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

Thin Thin Moe

Ph D

Mahidol University

研究点 (3)

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