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临床试验/CTRI/2024/05/067301
CTRI/2024/05/067301已完成2 期

Effect of neuromuscular electrical stimulation on rectus abdominus and transverse abdominus on the respiratory parameters in stroke survivors- a randomized controlled trial

NITTE Institute of physiotherapy, NITTE (Deemed to be university)1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Spirometry, palpation meter (PALM) device, chest expansion, Barthel Index

研究概览

简要总结

WHO defines stroke as rapidly developed clinical signs of focal(or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than vascular origin. Stroke has various symptoms including muscular and cognitive domines, one of the most overlooked symptom is the respiratory complications. The aim of the study is to identify the effectiveness of neuromuscular electrical stimulator on the respiratory and abdominal muscles and its effects on the respiratory parameters. Selected participants will be randomly allocated into control group and experimental group. The control group will be receiving conventional physiotherapy established for stroke management and the experimental group will receive the conventional physiotherapy along with neuro-muscular electrical stimulation, electrical stimulation will be given for 5 days with the frequency of 50 Hz, pulse duration of 300 microseconds. the outcome measures which will be used are spirometry, chest expansion using inch tape, PALM meter and Barthel index, these outcomes will be assessed pre and post intervention. The data collected will be assessed and analysed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Consent of the patient to participate in the study is required.
  • Participants should be aged between 40 and 75 years, inclusive of both men and women, with a clinical diagnosis of stroke.
  • The patient must be hemodynamically stable on the day of examination and intervention.
  • The duration of stroke from onset should be up to 6 months.

排除标准

  • Patients with a history of seizures, individuals who have undergone thoracic or abdominal surgery in the past year, and those experiencing respiratory tract infections should be noted.
  • Additionally, consideration should be given to patients with chronic respiratory diseases affecting respiratory muscle function (such as bronchial asthma or COPD), individuals with grade 4 and 5 strength of abdominal muscles, and patients with pacemakers.

结局指标

主要结局

Spirometry, palpation meter (PALM) device, chest expansion, Barthel Index

时间窗: outcomes will be assessed at baseline and after 1 week of intervention

次要结局

未报告次要终点

研究者

发起方
NITTE Institute of physiotherapy, NITTE (Deemed to be university)
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Adriana Maria Dsouza

Nitte Institute of Physiotherapy, Nitte( Deemed to be University)

研究点 (1)

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