StrokeNCT06782750
EFFECT of PHYSIOTHERAPY in STROKE
An observational study of Stroke, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
The study was aimed to determine the volumetric change in the corpus callosum after the rehabilitation program in patients with stroke. A total of 42 patients (22 males, 20 females), 21 right hemiplegic and 21 left hemiplegic patients with unilateral hemiplegia were enrolled in the rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Physiotherapy
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2024to 20 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diagnosed with stroke, had unilateral hemiplegia, practiced a rehabilitation program at the Physical Medicine and Rehabilitation Clinic of XXX University, and had no other neurological disease, were selected for the right and left groups.
Who may be able to join
- Patients diagnosed with stroke
- Patients had unilateral hemiplegia
- Patients practiced a rehabilitation program at the Physical Medicine and Rehabilitation
Who cannot join
- Patients had other neurological disease
- Patients had mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The EFFECT of PHYSIOTHERAPY on CORPUS CALLOSUM VOLUME in STROKE PATIENTS
The study was aimed to determine the volumetric change in the corpus callosum after the rehabilitation program in patients with stroke. A total of 42 patients (22 males, 20 females), 21 right hemiplegic and 21 left hemiplegic patients with unilateral hemiplegia were enrolled in the rehabilitation program. Traditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks. The corpus callosum volumes were measured and evaluated on Magnetic Resonance Imaging (MRI) images before and after the treatment.
Read the detailed description
Physical therapy after stroke contributes to the physical and social recovery of the paralyzed person. Corpus callosum is the commissural fibers consisting of white matter connecting the cortical areas between hemispheres. Its main function is to provide information exchange and coordination by establishing interhemispheric connections between areas in the right and left hemispheres. Inactivity and decreased physical activity may cause a decrease in the volume of the corpus callosum in patients with stroke. It was aimed to determine the volumetric change in the corpus callosum after the rehabilitation program in patients with stroke. A total of 42 patients (22 males, 20 females), 21 right hemiplegic and 21 left hemiplegic patients with unilateral hemiplegia were enrolled in the rehabilitation program. Traditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks. The corpus callosum volumes were measured and evaluated on Magnetic Resonance Imaging (MRI) images before and after the treatment.
- Conditions
- Stroke
- Being tested
- Physiotherapy
- Keywords
- Corpus Callosum, Hemiplegia, Physiotherapy, Stroke
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Traditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hemiplegic patients | Patients had unilateral hemiplegia, practiced a rehabilitation program at the Physical Medicine and Rehabilitation Clinic of Firat University, and had no other neurological disease, were selected for the right and left groups. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corpus Callosum Volume
The measurements of the patients were evaluated on sagittal T2-weighted images. The slice thickness is 1.1 mm. Starting from the slice where the borders of the corpus callosum were clearly seen on the sagittal images, the circumference of the corpus callosum was marked on all sagittal slices where the borders of the corpus callosum were seen in consecutive slices.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start10 May 2024
- Primary completion20 Aug 2024
- Study completion20 Sep 2024
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Bağlan Yentür, Firat University
- Investigators
- Songul Baglan Yentur, Principal investigator, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782750
- Sponsor's protocol ID
- 250963
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EFFECT of PHYSIOTHERAPY on CORPUS CALLOSUM VOLUME in STROKE PATIENTS
- ClinicalTrials.gov ID
- NCT06782750
- Acronym / sponsor ID
- 250963
- Conditions
- Stroke
- Keywords
- Corpus Callosum, Hemiplegia, Physiotherapy, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 20 Jan 2025 (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.
The study was aimed to determine the volumetric change in the corpus callosum after the rehabilitation program in patients with stroke. A total of 42 patients (22 males, 20 females), 21 right hemiplegic and 21 left hemiplegic patients with unilateral hemiplegia were enrolled in the rehabilitation program. Traditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks. The corpus callosum volumes were measured and evaluated on Magnetic Resonance Imaging (MRI) images before and after the treatment.
Detailed description
Physical therapy after stroke contributes to the physical and social recovery of the paralyzed person. Corpus callosum is the commissural fibers consisting of white matter connecting the cortical areas between hemispheres. Its main function is to provide information exchange and coordination by establishing interhemispheric connections between areas in the right and left hemispheres. Inactivity and decreased physical activity may cause a decrease in the volume of the corpus callosum in patients with stroke. It was aimed to determine the volumetric change in the corpus callosum after the rehabilitation program in patients with stroke. A total of 42 patients (22 males, 20 females), 21 right hemiplegic and 21 left hemiplegic patients with unilateral hemiplegia were enrolled in the rehabilitation program. Traditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks. The corpus callosum volumes were measured and evaluated on Magnetic Resonance Imaging (MRI) images before and after the treatment.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemiplegic patients | – | Other: PhysiotherapyPatients had unilateral hemiplegia, practiced a rehabilitation program at the Physical Medicine and Rehabilitation Clinic of Firat University, and had no other neurological disease, were selected for the right and left groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with stroke, had unilateral hemiplegia, practiced a rehabilitation program at the Physical Medicine and Rehabilitation Clinic of XXX University, and had no other neurological disease, were selected for the right and left groups.
Key inclusion criteria (3 listed)
- Patients diagnosed with stroke
- Patients had unilateral hemiplegia
- Patients practiced a rehabilitation program at the Physical Medicine and Rehabilitation
Key exclusion criteria (2 listed)
- Patients had other neurological disease
- Patients had mental disorders
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 |
|---|---|---|
| PhysiotherapyTraditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks. | Other | Hemiplegic patients |
Primary outcome
Corpus Callosum Volume
Time frame: up to 2 weeks
The measurements of the patients were evaluated on sagittal T2-weighted images. The slice thickness is 1.1 mm. Starting from the slice where the borders of the corpus callosum were clearly seen on the sagittal images, the circumference of the corpus callosum was marked on all sagittal slices where the borders of the corpus callosum were seen in consecutive slices.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Songul Baglan Yentur principal investigator
Firat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Firat University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jan 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corpus Callosum Volume (time frame: up to 2 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 20 Jan 2025.