Importance of Early Rehabilitation in Stroke Patients

NCT ID: NCT03965910

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-11-30

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.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group 1

Group 1:Early rehabilitation

Group Type: OTHER

Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data

Intervention Type: OTHER

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.

group 2

Group 2:Late rehabilitation

Group Type: OTHER

Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Poststroke rehabilitation and 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

• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Yaşar Keskin

Principal Investigator at Department of Physical Medicine and Rehabilitation at Bezmialem Vakif University, Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

28/09/2016-12 /25

Identifier Type: -

Identifier Source: org_study_id