EFFECT of PHYSIOTHERAPY in STROKE | NCT06782750

Studies
EFFECT of PHYSIOTHERAPY in STROKE

NCT06782750

Sponsor

Firat University

Status

Completed

Last Update Posted

Jan 20, 2025Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Stroke

Interventions

Physiotherapy

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2024Actual

Primary Completion Date

Aug 20, 2024Actual

Completion Date

Sep 20, 2024Actual

First Submitted Date

Dec 6, 2024

First Submission Date that Met QC Criteria

Jan 16, 2025

First Posted Date

Jan 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2025

Last Update Posted Date

Jan 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Songül Bağlan Yentür, Head of Physiotherapy and Rehabilitatrion, Firat UniversityPrincipal Investigator

Lead Sponsor

Firat UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: Physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physiotherapy	Other	Traditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks.	Hemiplegic patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	up to 2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with stroke
Patients had unilateral hemiplegia
Patients practiced a rehabilitation program at the Physical Medicine and Rehabilitation

Exclusion Criteria:

Patients had other neurological disease
Patients had mental disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Songul Baglan Yentur	Firat University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Firat University		Elâzığ	University	23119	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D006429	Hemiplegia

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided