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Clinical Trials/NCT06084273
NCT06084273
Completed
Not Applicable

Effectıveness Of Relaxation And Respiratory Exercise On Sleep Quality, Depressıon And Spasticity In Hemiplegic Stroke Patients: Prelimınary Findings

Derya Azim1 site in 1 country30 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Derya Azim
Enrollment
30
Locations
1
Primary Endpoint
Sleep quality assessment
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Background: Our study aims to determine the effect of relaxation and breathing exercises in addition to the treatment procedure on depression level, sleep quality, and spasticity in hemiplegic patients.

Methods: Thirty patients aged 40-70 years diagnosed with hemiplegia were included in the study. All patients received the same Bobath exercise three days a week for six weeks. Patients in Group 2 additionally received breathing and relaxation exercises. Sleep quality assessment by Pittsburgh Sleep Quality Index (PUKI), depression by Hospital Anxiety and Depression Scale (HADS), and spasticity by Modified Ashworth scale (MAS) were used. All assessments were made at baseline and six weeks after exercise treatments.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
December 30, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Derya Azim
Responsible Party
Sponsor Investigator
Principal Investigator

Derya Azim

Assistant Professor

Bandırma Onyedi Eylül University

Eligibility Criteria

Inclusion Criteria

  • The study included patients who met the following inclusion criteria:
  • having had a stroke at least six months ago,
  • possessing adequate cognitive functions,
  • having no pre-existing sleep problems before the disease,
  • absence of emotional disturbance prior to the disease,
  • voluntary participation in the study,
  • no cardiovascular problems,
  • having a score of 1, 1+, or two according to the modified Ashworth Scale

Exclusion Criteria

  • having a traumatic stroke caused by malignancy or other organic factors, alcohol or drug addiction,
  • having a score of 3 or 4 according to the modified Ashworth Scale

Outcomes

Primary Outcomes

Sleep quality assessment

Time Frame: 30 min

The subjective sleep questionnaire, the PUKI, is used to assess individuals' sleep quality, sleep duration, presence of sleep problems, and the severity of sleep problems over the past month.

Spasticity assessment

Time Frame: 15 min

Spasticity is a method used to determine the severity of spasticity. The assessment is based on the subjective rating of the resistance felt by the evaluator during the evaluation. It is divided into six degrees: 0 = Normal muscle tone, 1 = Slight increase in muscle tone with minimal resistance felt at the end of the range of motion, 1+ = Minimal resistance felt in less than half of the range of motion, 2 = more pronounced increase in muscle tone but affected parts can be moved without difficulty, 3 = Passive movement is complex and requires significant effort, with a noticeable increase in muscle tone, 4 = Affected parts are rigid in flexion and extension, with severe increase in tone.

Depression assessment

Time Frame: 30 min

The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale developed to determine the risk, level, and severity of anxiety and depression in individuals

Study Sites (1)

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