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 were estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation and mindfulness breathing, while the control group will receive neuromuscular stimulation only.

Detailed Description

It is an interventional study in which 60 stroke patients will be estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation and mindfulness breathing, while the control group will receive neuromuscular stimulation only. The experimental group participants will receive neuromuscular electrical stimulation that will last 12 consecutive weeks, three sessions per week protocol with Mindful breathing is a mindfulness exercise that involves using breathing as an object of attention.

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: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• 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.

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.

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
ventilatory function	12 weeks	By a spirometer, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), the ratio of forced vital capacity to forced expiratory volume (FEV1/FVC), and peak expiratory flow will be measured.

Secondary Outcome Measures

Name	Time	Method
level of stress	12 weeks	perceived stress questionnaire Individual scores on the perceived stress questionnaire can range from 0 to 40 with higher scores indicating higher perceived tress
Functional independence measure	12 weeks	The Functional independence measure consists of 18 measures organized into six dimensions and ranges from 18 to 126
level of physical function	12 weeks	short physical performance battery group of measures that combines the results of the gait speed, chair stand and balance tests

Trial Locations

Locations (1)

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