Effect of Neuromuscular Stimulation and Mindfulness Breathing in Patients With Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: neuromuscular stimulation ,mindfulness breathing and traditional physiotherapy program; Other: traditional physiotherapy program

• Registration Number: NCT06302946
• Lead Sponsor: Cairo University

Brief Summary

It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation , mindfulness breathing and traditional physiotherapy while the control group will stick to traditional physiotherapy only.

Detailed Description

It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation , mindfulness breathing and traditional physiotherapy while the control group will stick to traditional physiotherapy only. The experimental group participants will receive functional electrical stimulation ((Ev-906,4CH Digital TENS/EMS, Taiwan)) that will last 8 consecutive weeks, three sessions per week (24 sessions in total) protocol with Mindful breathing is a mindfulness exercise that involves using breathing as an object of attention. 15-minute mindful breathing intervention will be adapted. It consists of the following three steps: (a) adopt a physical posture, (b) establish a mindfulness anchor, and (c) maintain mindfulness. To adopt a physical posture, participants will sit upright on a chair, which helps them to maintain positive mental health and well-being. Participants will be then taught how to establish a mindfulness practice by controlling the mind to be present in the moment. One of the easiest ways to do this is by paying attention to the process of breathing. In the last step, participants will be encouraged to maintain their focus in the present moment and regulate ruminations while continuing to be in a mindful state by paying attention to the breathing process

Study Timeline

• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-12
• Study Start: 2024-03-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-21
• Last Update Posted: 2024-07-23
• Primary Completion: 2025-05-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The subject selection will be according to the following criteria:
• All Patients of this study will be diagnosed as stroke and the diagnosis will be confirmed by computed tomography or MRI (El-Tamawy et al., 2021).
• Age of patients will be ranged from 50 to 65years (males and females).
• All patients will be hemodynamically stable.
• Patients with good cognition that enables them to understand the requirements of the study.
• Patients with following features: (Abiodun and Dolapo , 2021)
• FVC : 60-69% (moderate)
• FEV1 : 60-69% (moderate)
• FEV1/FVC : 50-59% (moderate)
• PEF : 50-80% (yellow zone)

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Exclusion Criteria

• • The potential participants will be excluded if they meet one of the following criteria:

  • Patients who cannot follow instructions as sensory aphasia, blindness, dementia, and deafness.
  • Patients with any orthopedic, neurological, or chest disorders that affect trunk muscles control or cause respiratory disorders as COPD.
  • Patients with cognitive and psychiatric disorders.
  • Patients with unstable cardiovascular conditions.
  • Patients with contraindications to neuro electrical stimulation as:
  • Cardiac pace maker.
  • Acute abdominal surgery.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	neuromuscular stimulation ,mindfulness breathing and traditional physiotherapy program	will receive neuromuscular stimulation , mindfulness breathing and traditional physiotherapy program
control group	traditional physiotherapy program	the control group will stick to the traditional physiotherapy program only.

Primary Outcome Measures

Name	Time	Method
level of physical function	8 weeks	short physical performance battery group of measures that combines the results of the gait speed, chair stand and balance tests

Secondary Outcome Measures

Name	Time	Method
level of stress	8 weeks	perceived stress questionnaire Individual scores on the perceived stress questionnaire can range from 0 to 40 with higher scores indicating higher perceived tress
ventilatory function	8 weeks	A hand-held lung function spirometry will be used to measure the expiratory spirometric parameters. The patient will be positioned in a comfortable sitting position and made familiar with the device first before the measurements will be recorded

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Cairo, Dokki, Egypt