Effect of Neuromuscular Stimulation and Mindfulness Breathing in Patients With Stroke

NCT ID: NCT06302946

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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experimental group

will receive neuromuscular stimulation and mindfulness breathing

Group Type EXPERIMENTAL

neuromuscular stimulation and mindfulness breathing

Intervention Type OTHER

Receive neuromuscular stimulation and mindfulness breathing; the experimental group participants will receive neuromuscular electrical stimulation with Mindful breathing.

control group

The control group will receive neuromuscular stimulation only.

Group Type ACTIVE_COMPARATOR

neuromuscular electrical stimulation

Intervention Type OTHER

participants in the control group perceived neuromuscular electrical stimulation

Interventions

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neuromuscular stimulation and mindfulness breathing

Receive neuromuscular stimulation and mindfulness breathing; the experimental group participants will receive neuromuscular electrical stimulation with Mindful breathing.

Intervention Type OTHER

neuromuscular electrical stimulation

participants in the control group perceived neuromuscular electrical stimulation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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marwa mahmoud elsayed mahmoud

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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marwa elsayed

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Physical Therapy

Cairo, Dokki, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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marwa elsayed, PhD

Role: CONTACT

0201156033818

Facility Contacts

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marwa M elsayed, phd

Role: primary

01156033818 ext. 02

marwa M elsayed, ph.d

Role: backup

01156033818 ext. 02

Other Identifiers

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P.T.REC/012/005024

Identifier Type: -

Identifier Source: org_study_id

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