Importance of Early Rehabilitation in Stroke Patients (stroke)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation, diffusion tensor imaging
Eligibility Criteria
Inclusion Criteria:
- Patients suffering cerebrovascular accident (CVA)-associated stroke for the first time with a cortical or subcortical unilateral ischemia or hemorrhage
- The patients aged 35-75 years
- Patiients with ability to understand and follow the instructions
- Patients with the absence of serious cognitive deficits.
Exclusion Criteria:
- Patients who had spinal-cord lesion
- Patients who had history of traumatic brain injury,
- Patients who had accompanying neurological disease (multiple sclerosis, Parkinson's disease, dementia)
- Patients who had tumor
- Patients who had history of convulsions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
group 1
group 2
Arm Description
Group 1:Early rehabilitation
Group 2:Late rehabilitation
Outcomes
Primary Outcome Measures
Change in Cranial diffusion tractography
Diffusion tensor imaging (DTI) is based on determining tissue structure by measuring diffusion rate and direction of movement of water molecules in vivo. DTI is the only in vivo method of mapping white-matter pathways in the human brain. Tractography is the technique for mapping white-matter structure with DTI data
Change in Fugl-Meyer Assessment Scale score(FMA)
FMA is a stroke-specific, performance-based impairment index. (0 point : Flaccid paralysis 100points=Normal).
Secondary Outcome Measures
Full Information
NCT ID
NCT03965910
First Posted
April 10, 2019
Last Updated
May 26, 2019
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT03965910
Brief Title
Importance of Early Rehabilitation in Stroke Patients
Acronym
stroke
Official Title
Demonstration the Importance of the Early Rehabilitation in Stroke Patients Based on Diffüsion Tensor Imaging Data
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stroke is one of the leading health problems in the community and it is the most common life-threatening neurological disease impairing the quality of life. Early rehabilitation of stroke is very important. The purpose of our study was to evaluate, through clinical examination, whether there was any difference between patients who underwent early rehabilitation and those who underwent late rehabilitation in terms of improvements in motor and functional impairment after rehabilitation, and also to evaluate this difference objectively by analyzing white-matter pathways (corticospinal tracts) using DTI.
Detailed Description
Methods: Twenty-eight (28) adults (12 women, 16 men, average age 58 years) with first-time stroke who met the study criteria were divided into two groups depending on the duration of their stroke at the time of their presentation to our facility. Group 1 consisted of patients who underwent rehabilitation program within the first 1-4 weeks after stroke, whereas Group 2 consisted of patients who underwent rehabilitation program within 5-8 weeks after stroke. Both groups were evaluated using the BRS, FMA scale, FAC and BI scales. For cranial imaging, DTI was obtained 1 day before and 1 day after treatment. FA and ADC values of corticospinal tracts were performed using DTI.
Intervention: Patients were enrolled in a rehabilitation program, which was designed for a total of 4 weeks, with daily sessions lasting a total of 1 h on 5 days of a week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, rehabilitation, diffusion tensor imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The clinician evaluating the patient and the radiologist evaluating the MRI were blinded to the groups.
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Other
Arm Description
Group 1:Early rehabilitation
Arm Title
group 2
Arm Type
Other
Arm Description
Group 2:Late rehabilitation
Intervention Type
Other
Intervention Name(s)
Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data
Other Intervention Name(s)
Poststroke rehabilitation and diffusion tensor imaging
Intervention Description
Twenty-eight stroke patients aged 36-72 years admitted to the our Physical Medicine and Rehabilitation Outpatient Clinics were included in this prospective study. After the approval of the ethics committee, written informed consent was obtained from the patients after they were informed about the content and purpose of the study, the schedule of rehabilitation to be administered, and the features of cranial magnetic resonance imaging (MRI) to be performed. Patients with confirmed diagnosis of stroke by computed tomography and/or MRI techniques were randomized into two groups according to the onset of post-stroke rehabilitation. The patients were randomized according to the duration of their admission to our clinic for rehabilitation. Group 1 consisted of patients admitted to our clinic within 1-4 weeks after stroke; Group 2 consisted of patients admitted within 5-8 weeks after stroke.
Late initiation of rehabilitation in Group 2 patients is not a condition related to our clinic.
Primary Outcome Measure Information:
Title
Change in Cranial diffusion tractography
Description
Diffusion tensor imaging (DTI) is based on determining tissue structure by measuring diffusion rate and direction of movement of water molecules in vivo. DTI is the only in vivo method of mapping white-matter pathways in the human brain. Tractography is the technique for mapping white-matter structure with DTI data
Time Frame
performed 1 day before and 1 month after treatment
Title
Change in Fugl-Meyer Assessment Scale score(FMA)
Description
FMA is a stroke-specific, performance-based impairment index. (0 point : Flaccid paralysis 100points=Normal).
Time Frame
performed 1 day before the end of the second week of the treatment and 1 day after the completion of the treatment
10. Eligibility
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suffering cerebrovascular accident (CVA)-associated stroke for the first time with a cortical or subcortical unilateral ischemia or hemorrhage
The patients aged 35-75 years
Patiients with ability to understand and follow the instructions
Patients with the absence of serious cognitive deficits.
Exclusion Criteria:
Patients who had spinal-cord lesion
Patients who had history of traumatic brain injury,
Patients who had accompanying neurological disease (multiple sclerosis, Parkinson's disease, dementia)
Patients who had tumor
Patients who had history of convulsions
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
I do not to want to share IPD of my study. But if a researcher reaches me about the subject and wants me to share bended, I share IPD.
Learn more about this trial
Importance of Early Rehabilitation in Stroke Patients
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