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Importance of Early Rehabilitation in Stroke Patients (stroke)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965910
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yaşar Keskin, Bezmialem Vakif University

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.

Condition or disease Intervention/treatment Phase
Stroke Other: Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The clinician evaluating the patient and the radiologist evaluating the MRI were blinded to the groups.
Primary Purpose: Treatment
Official Title: Demonstration the Importance of the Early Rehabilitation in Stroke Patients Based on Diffüsion Tensor Imaging Data
Actual Study Start Date : November 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
group 1
Group 1:Early rehabilitation
Other: Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data

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.

Other Name: Poststroke rehabilitation and diffusion tensor imaging

group 2
Group 2:Late rehabilitation
Other: Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data

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.

Other Name: Poststroke rehabilitation and diffusion tensor imaging




Primary Outcome Measures :
  1. Change in Cranial diffusion tractography [ Time Frame: performed 1 day before and 1 month after treatment ]
    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

  2. Change in Fugl-Meyer Assessment Scale score(FMA) [ Time Frame: performed 1 day before the end of the second week of the treatment and 1 day after the completion of the treatment ]
    FMA is a stroke-specific, performance-based impairment index. (0 point : Flaccid paralysis 100points=Normal).



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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
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
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Responsible Party: Yaşar Keskin, Principal Investigator at Department of Physical Medicine and Rehabilitation at Bezmialem Vakif University, Medical Doctor, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03965910    
Other Study ID Numbers: 28/09/2016-12 /25
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yaşar Keskin, Bezmialem Vakif University:
stroke
rehabilitation
diffusion tensor imaging
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases