跳至主要内容
临床试验/CTRI/2018/05/013725
CTRI/2018/05/013725招募中2 期

Effectiveness of task oriented trunk training on trunk control and community reintegration in comparison with conventional therapy among acute stroke subjects: a randomized controlled trial

Kasturba Medical College1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2018年5月13日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
114
试验地点
1
主要终点
1)Trunk Impairment Scale

研究概览

简要总结

Subjects diagnosed with stroke referred to physiotherapy will be approached and informed consent will be collected from them. Upon the consent they will be screened for inclusion and exclusion criteria for eligibility. The eligible subjects will be randomized into two groups i.e. control group and experimental group through block randomization method. after randomization demographic data will be collected and baseline parameters will be assessed using both the primary and secondary outcome measures. Both the groups will get two weeks of hospital based intervention; post which they will get 4 weeks of home exercises.

Control group will receive conventional impairment based rehabilitation for upper limb, lower limb and trunk in hospital based rehabilitation and post discharge they will be asked to continue the same as home program.

Experimental Group will receive conventional impairment based rehabilitation for upper and lower limb; and task oriented training for trunk in hospital based rehabilitation and as same will be continued as home program for 4 weeks.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Clinically stable subjects with first episode of supra-tentorial stroke in the acute stage.
  • •20 years to 80 years of age.
  • •Mini-Mental Scale Examination score of ≥
  • •Ability to sit for 30 seconds.

排除标准

  • •Multiple episode of stroke.
  • •Neurological disorders other than stroke that could influence balance and ambulation.
  • •Subjects with a history of diagnosed musculoskeletal or cardiovascular disorders of the trunk and/or lower extremities who can’t tolerate treatment positions and intensity.
  • •Subject having perceptual issues like hemi-neglect, pusher’s syndrome, severe visual field defects and somato-sensory deficit.

结局指标

主要结局

1)Trunk Impairment Scale

时间窗: pre intervention, 2 weeks post inpatient rehabilitation, 4 weeks post home rehabilitation and 6 moths follow up assessment

2)Trunk muscle strength using hand Held Dynamometer

时间窗: pre intervention, 2 weeks post inpatient rehabilitation, 4 weeks post home rehabilitation and 6 moths follow up assessment

3) RNLI for Community Re-integration

时间窗: pre intervention, 2 weeks post inpatient rehabilitation, 4 weeks post home rehabilitation and 6 moths follow up assessment

次要结局

  • BESTest for balance, ABC for Balance self Efficacy, PALM for pelvic alignment(pre intervention, 2 weeks post inpatient rehabilitation, 4 weeks post home rehabilitation and 6 moths follow up assessment)

研究者

申办方类型
Private medical college

研究点 (1)

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