Effect of Neuromuscular Stimulation and Mindfulness Exercise in Patients With Stroke

March 11, 2026 updated by: marwa mahmoud elsayed mahmoud, Cairo University

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

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 , while the control group will receive neuromuscular stimulation only.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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, 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 Mindfulness.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dokki
      • Cairo, Dokki, Egypt, 11432
        • Recruiting
        • Faculty of Physical Therapy
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
The control group will receive neuromuscular stimulation only.
Other: neuromuscular electrical stimulation
participants in the control group perceived neuromuscular electrical stimulation
Experimental: experimental group
will receive neuromuscular stimulation and mindfulness
Other: neuromuscular stimulation and mindfulness
Receive neuromuscular stimulation and mindfulness breathing; the experimental group participants will receive neuromuscular electrical stimulation with Mindfulness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ventilatory function
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of stress
Time Frame: 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
12 weeks
Functional independence measure
Time Frame: 12 weeks
The Functional independence measure consists of 18 measures organized into six dimensions and ranges from 18 to 126
12 weeks
level of physical function
Time Frame: 12 weeks
short physical performance battery group of measures that combines the results of the gait speed, chair stand and balance tests
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: marwa elsayed, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

sharing with other researches

IPD Sharing Time Frame

12 months

IPD Sharing Access Criteria

after acceptance of publishing journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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