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临床试验/CTRI/2023/07/055866
CTRI/2023/07/055866已完成2 期

Effect of truncal exercise and patient preferred sitting tasks training on functional ability in sub-acute stroke

KMCH Institute of health sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月8日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Trunk balance and control

研究概览

简要总结

Stroke is the second leading cause of disability and death. Research suggests that incidence of stroke in India ranges between 105 and 152/1,00,000 people per year. Most patients with acute and sub – acute stroke have a poor sitting balance. Thus, the prevalence of sitting balance impairments among post – stroke with values ranging from 16.7% to as high as 83%.However, the trunk training exercise is given early after stroke is most important training that specifically targets trunk muscles and trunk functions at post – stroke. The  intervention most often focus on the time therapy (min/hours).Repeated practice of a challenging movement by patient preferred sitting task can produce physiological changes in motor neurons.              

PROCEDURE                    

60 In- patients of Kovai Medical Center and Hospital undergoing treatment for rehabilitation will be selected in the study. Patients will be recruited on their first referral of physiotherapy from day 3 considered as medically stable by their consulting physicians. This study will select in – patients referred to Department of Physical Medicine and Rehabilitation, Kovai Medical Center and Hospital. Patients who fulfill inclusion criteria and provide informed consent will be selected for the study. Patient vitals are to be screened and observed before, during and end of the treatment session. Group A – experimental group receives truncal exercise with patient preferred sitting task training.

Group B – control group receives the conventional therapy alone.

Pre – test  and post – test measures are using trunk impairment scale (TIS), function in sitting test (FIST) and Zarit Burden Interview (ZBI) , 5 times Sit to stand at  test.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • •Patients diagnosed with infarct or hemorrhage of right or left hemisphere which is investigated by CT/MRI scan 2)Patients with loss of sitting balance and trunk control with TIS Score of 3 with medically stable.
  • •Post stroke from day 3 4) Healthy caregivers with the age of 20 – 60 years old.

排除标准

  • •Subjects with non – stroke related sensory or motor impairments which affecting their motor performance.
  • •Any perceptual dysfunctions such as Unilateral neglect and disorders of spatial perception.
  • •Modified rankin scale score >4.

结局指标

主要结局

Trunk balance and control

时间窗: Baseline | 3 weeks | 8 weeks

次要结局

  • sitting balance(Caregiver Burden)

研究者

发起方
KMCH Institute of health sciences
申办方类型
Research institution and hospital

研究点 (1)

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