Importance of Early Rehabilitation in Stroke Patients

NCT03965910 | Completed

• 1 other identifier: 28/09/2016-12 /25
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Keywords

stroke; rehabilitation; diffusion tensor imaging

Outcome Measures

Primary Outcomes (2)

• 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

  performed 1 day before and 1 month after treatment

• Change in Fugl-Meyer Assessment Scale score(FMA)

  FMA is a stroke-specific, performance-based impairment index. (0 point : Flaccid paralysis 100points=Normal).

  performed 1 day before the end of the second week of the treatment and 1 day after the completion of the treatment

Study Arms (2)

group 1

OTHER

Group 1:Early rehabilitation

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

group 2

OTHER

Group 2:Late rehabilitation

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

Interventions

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

Also known as: Poststroke rehabilitation and diffusion tensor imaging

group 1; group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Stroke

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The clinician evaluating the patient and the radiologist evaluating the MRI were blinded to the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator at Department of Physical Medicine and Rehabilitation at Bezmialem Vakif University, Medical Doctor

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: May 29, 2019
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: November 1, 2017
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share