StrokeNCT06302946
Effect of Neuromuscular Stimulation and Mindfulness Exercise in Patients With Stroke
A study testing neuromuscular stimulation and mindfulness and neuromuscular electrical stimulation in people with Stroke, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- neuromuscular stimulation and mindfulness and neuromuscular electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Cairo, Dokki, 11432
marwa M elsayed, phd, 01156033818 ext. 02, marwadd999@gmail.com
marwa M elsayed, ph.d, 01156033818 ext. 02, marwadd999@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- neuromuscular stimulation and mindfulness, neuromuscular electrical stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular stimulation and mindfulnessOther
Receive neuromuscular stimulation and mindfulness breathing; the experimental group participants will receive neuromuscular electrical stimulation with Mindfulness.
neuromuscular electrical stimulationOther
participants in the control group perceived neuromuscular electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | will receive neuromuscular stimulation and mindfulness Receives: Other: neuromuscular stimulation and mindfulness |
| control group | Active comparator | The control group will receive neuromuscular stimulation only. Receives: Other: neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
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
Measured: 12 weeks
Functional independence measure
The Functional independence measure consists of 18 measures organized into six dimensions and ranges from 18 to 126
Measured: 12 weeks
level of physical function
short physical performance battery group of measures that combines the results of the gait speed, chair stand and balance tests
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Mar 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa mahmoud elsayed mahmoud, Cairo University
- Investigators
- marwa elsayed, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302946
- Sponsor's protocol ID
- P.T.REC/012/005024
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing with other researches
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Stimulation and Mindfulness Exercise on Pulmonary, Physical Functions and Stress in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06302946
- Acronym / sponsor ID
- P.T.REC/012/005024
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: neuromuscular stimulation and mindfulnesswill receive neuromuscular stimulation and mindfulness |
| control group | Active comparator | Other: neuromuscular electrical stimulationThe control group will receive neuromuscular stimulation only. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- • The potential participants will be excluded if they meet one of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscular stimulation and mindfulnessReceive neuromuscular stimulation and mindfulness breathing; the experimental group participants will receive neuromuscular electrical stimulation with Mindfulness. | Other | experimental group |
| neuromuscular electrical stimulationparticipants in the control group perceived neuromuscular electrical stimulation | Other | control group |
Primary outcome
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.
3 secondary outcomes
level of stress
Time frame: 12 weeks
Functional independence measure
Time frame: 12 weeks
level of physical function
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes. sharing with other researches
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
marwa elsayed principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular stimulation and mindfulness and neuromuscular electrical stimulation in people with Stroke, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact marwa elsayed, PhD (0201156033818, marwa.elsaid@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilatory function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.