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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
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation, diffusion tensor imaging

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

    First Posted
    April 10, 2019
    Last Updated
    May 26, 2019
    Sponsor
    Bezmialem Vakif University
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    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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