Effect of Neuromuscular Stimulation and Mindfulness Breathing in Patients With Stroke

Stroke Clinical Trial

Official title:

Effect of Neuromuscular Stimulation and Mindfulness Breathing on Pulmonary, Physical Functions and Stress in Patients With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302946
• Other study ID #: P.T.REC/012/005024
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: marwa elsayed, PhD
• Phone: 0201156033818
• Email: marwa.elsaid[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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)

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• neuromuscular stimulation ,mindfulness breathing and traditional physiotherapy program
receive neuromuscular stimulation ,mindfulness breathing and traditional physiotherapy program. 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
• traditional physiotherapy program
participants in the control group perceived the traditional physiotherapy program

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of physical function	short physical performance battery group of measures that combines the results of the gait speed, chair stand and balance tests	8 weeks
Secondary	ventilatory function	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	8 weeks
Secondary	level of stress	perceived stress questionnaire Individual scores on the perceived stress questionnaire can range from 0 to 40 with higher scores indicating higher perceived tress	8 weeks