Importance of Early Rehabilitation in Stroke Patients

Not Applicable

Completed

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

• Registration Number: NCT03965910
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-11
• Primary Completion: 2016-12
• Study Completion: 2017-11
• Study First Submitted: 2019-04-10
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-26
• Last Update Submitted: 2019-05-26
• Study First Posted: 2019-05-29
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data	Group 1:Early rehabilitation
group 2	Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data	Group 2:Late rehabilitation

Primary Outcome Measures

Name	Time	Method
Change in Cranial diffusion tractography	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)	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).