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临床试验/CTRI/2024/12/077921
CTRI/2024/12/077921已完成不适用

Effect Of Triggered Functional Electrical Stimulation In Conjunction With Proprioceptive Neuromuscular Facilitation On Sitting Balance, Trunk Control And Functional Independence In Individuals With Stroke.

Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月21日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Sitting Balance (Sitting Balance Scale)

研究概览

简要总结

Stroke is a debilitating neurological condition characterized by sensory, motor, autonomic, and/or bowel dysfunction caused by a lesion to the brain that leads to abnormal sitting balance,  trunk control deficits and functional dependence. As most of the functional and other day to day activities performed are carried out in sitting position, sitting balance and trunk control is considered as a prerequisite for effective performance of day-to-day tasks and other activities.

Proprioceptive neuromuscular facilitation (PNF) and Functional electrical stimulation (FES) are two promising interventions that have shown to improve sitting balance, trunk control and functional independence in individuals with various neurological disorders, but their combined effectiveness has not been explored yet. Hence this research aims to find their effectiveness on sitting balance, trunk control and functional independence in individuals with stroke.

Patients will be screened based on inclusion and exclusion criteria. They will be enrolled into 2 groups with the help of random allocation software. One group will receive Triggered FES in conjunction with PNF along with conventional physiotherapy 5 times a week for 4 weeks. Whereas the second group will receive sham stimulation in conjunction with PNF along with conventional physiotherapy for the same duration.

The outcome measurements will be done by using the following scales: Sitting Balance Scale (SBS), Trunk Impairment Scale (TIS), Postural Assessment Scale for Stroke (PASS) and Functional Independence Measure (FIM) . Variations in outcome measurement scores: pre, post and 1 month follow up post completion will help us find out the effectiveness of triggered functional electrical stimulation in conjunction with proprioceptive neuromuscular facilitation on sitting balance, trunk control and functional independence and in individuals with stroke.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
50.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Hemiparesis with first stroke.
  • Duration ˃3 months.
  • Age: 50-70 years.
  • Those who can’t maintain unsupported sitting balance for five minutes.
  • Individuals with ≥ 4 stage of Brunnstorm motor recovery scale.
  • Mini‑Mental State Examination score ˃24.

排除标准

  • Subjects with severe aphasia or cognitive impairment.
  • Subjects who were suffering from known case of brain tumor, head injury, infective conditions of brain, or from other neurological diseases.
  • Subjects with unilateral neglect.
  • Subjects with vestibular organ diseases.
  • Those who have electrical stimulation contraindication.
  • History of diagnosed musculoskeletal disorders of the trunk.

结局指标

主要结局

Sitting Balance (Sitting Balance Scale)

时间窗: Week 0 (pre intervention, baseline), Week 4 (post intervention), 1 month follow up (1 month after completion of the intervention)

Trunk Control (Trunk Impairment Scale and Postural Assessment Scale for Stroke)

时间窗: Week 0 (pre intervention, baseline), Week 4 (post intervention), 1 month follow up (1 month after completion of the intervention)

次要结局

  • Functional Independence (Functional Independence Measure )(Week 0 (pre intervention, baseline), Week 4 (post intervention), 1 month follow up (1 month after completion of the intervention))

研究者

发起方
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Harshita Jain

Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences

研究点 (1)

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