NCT06302946

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 , while the control group will receive neuromuscular stimulation only.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
20mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

February 14, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
2 years until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

February 14, 2024

Last Update Submit

March 11, 2026

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • ventilatory function

    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 Outcomes (3)

  • level of stress

    12 weeks

  • Functional independence measure

    12 weeks

  • level of physical function

    12 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

will receive neuromuscular stimulation and mindfulness

Other: neuromuscular stimulation and mindfulness

control group

ACTIVE COMPARATOR

The control group will receive neuromuscular stimulation only.

Other: neuromuscular electrical stimulation

Interventions

neuromuscular electrical stimulationOTHER

participants in the control group perceived neuromuscular electrical stimulation

control group
neuromuscular stimulation and mindfulnessOTHER

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

experimental group

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, Dokki, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • marwa elsayed

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

marwa elsayed, PhD

CONTACT

0201156033818marwa.elsaid@cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 14, 2024

First Posted

March 12, 2024

Study Start

March 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

sharing with other researches

Shared Documents
STUDY PROTOCOL
Time Frame
12 months
Access Criteria
after acceptance of publishing journal
More information

Locations

EG(1)