Importance of Early Rehabilitation in Stroke Patients

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.

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Key information

Conditions

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

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Poststroke rehabilitation and diffusion tensor imaging

Primary outcomes

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
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).

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Acronym: stroke

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: May 29, 2019
Registry last updated: May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed