NCT06758791

Brief Summary

Stroke, which can occur due to many different causes and is one of the most common neurological conditions, is one of the main causes of disability worldwide. The most common disorders that occur after stroke are motor disorders. In addition, respiratory problems such as changes in breathing patterns and decreased ventilation function may accompany these patients. Respiratory problems are an important risk factor in the development of long-term mortality for both cardiovascular diseases and stroke. With all these changes, a serious decrease in patients' activity performance is observed. While the focus is on motor function losses in stroke rehabilitation, problems in pulmonary functions do not receive the necessary attention. In stroke rehabilitation, evaluating and treating patients from every perspective will further increase the effectiveness of the treatments applied.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

December 28, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

December 28, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

December 28, 2024

Last Update Submit

January 11, 2025

Conditions

Keywords

Chronic StrokeIschemicRespiratory MusclesPulmonary Funtion TestBalanceGait

Outcome Measures

Primary Outcomes (1)

  • Respiratory Function Tests

    These are tests used in combination with the clinic to evaluate and grade damage and abnormalities in respiratory system functions. Spirometric measurement reflects the time, volume and flow values measured during normal breathing, forced inspiration, forced expiration, deep and rapid breathing for a certain period of time. The test is evaluated by comparing the basal values obtained by creating gender, height, weight and age groups in healthy people in the community where the measurement is made. Lung functions physiologically consist of four volumes. Expiratory reserve volume (ERV), inspiratory reserve volume (IRV), residual volume (RV) and tidal volume (VT). The sum of the four volumes gives the total lung capacity (TLC).

    1 day (It will be performed one time.)

Secondary Outcomes (2)

  • 6-Minute Walk Test

    1 day (It will be performed one time.)

  • Berg Balance Scale

    1 day (It will be performed one time.)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ischemic Stroke Patients

You may qualify if:

  • Having had a stroke for the first time
  • Being 18 years of age or older
  • Having an ischemic type of stroke
  • Having had a stroke for at least 6 months
  • Having a Modified Rankin Score of ≥3
  • Being able to communicate
  • Agreeing to participate in the study

You may not qualify if:

  • Hemispatial neglect
  • Having a psychiatric disease
  • Having any respiratory problems before the stroke
  • Having any orthopedic, neurological, cardiopulmonary disease that would constitute a contraindication for the protocols to be applied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beykent Üniversity

Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • İbrahim Halil Ural, M.D.

    Beykent University

    PRINCIPAL INVESTIGATOR
  • Dudu Kübra Akyol, PT

    IAU Medical Park Florya Hospital

    STUDY CHAIR
  • Sümeyye Akçay, PT

    Saglik Bilimleri University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

December 28, 2024

First Posted

January 6, 2025

Study Start

December 28, 2024

Primary Completion

March 2, 2025

Study Completion

April 2, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01

Locations