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Investigation Of Two Different İnterventions İn Hemiplegic Patients

Primary Purpose

Stroke, Physiotherapy and Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bobath Exercises
Breathing Exercises,Breathing Exercises, Bobath Exercises
Sponsored by
Derya Azim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Depression, Exercise, Relaxation, Pain

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Aydın University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bobath Exercises

Breathing Exercises,Breathing Exercises, Bobath Exercises

Arm Description

Bobath Exercises

Breathing Exercises,Breathing Exercises, Bobath Exercises

Outcomes

Primary Outcome Measures

Sleep quality assessment
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.
Depression assessment
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
Spasticity assessment
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.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2023
Last Updated
October 9, 2023
Sponsor
Derya Azim
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1. Study Identification

Unique Protocol Identification Number
NCT06084273
Brief Title
Investigation Of Two Different İnterventions İn Hemiplegic Patients
Official Title
Effectıveness Of Relaxation And Respiratory Exercise On Sleep Quality, Depressıon And Spasticity In Hemiplegic Stroke Patients: Prelimınary Findings
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Derya Azim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Physiotherapy and Rehabilitation
Keywords
Depression, Exercise, Relaxation, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bobath Exercises
Arm Type
Experimental
Arm Description
Bobath Exercises
Arm Title
Breathing Exercises,Breathing Exercises, Bobath Exercises
Arm Type
Experimental
Arm Description
Breathing Exercises,Breathing Exercises, Bobath Exercises
Intervention Type
Other
Intervention Name(s)
Bobath Exercises
Intervention Description
The Bobath approach aims to enhance postural and neuromotor control goal-directedly, leading to functional improvement. Our study selected the Bobath 30 exercises from the fundamental exercises to create a program specific to the goal and targeting functionality. The ten Bobath exercises performed by all participants in the study are as follows: Bridging Exercise, Latissimus Stretch Exercise, Autoinhibition Exercise, Dorsiflexion Training, Sitting Balance Training, Upper Extremity Weight Shifting Exercise, Lower Extremity Weight Shifting Exercise, Oblique Abdominal Strengthening Exercise, Knee Control Training, and Walking Training.
Intervention Type
Other
Intervention Name(s)
Breathing Exercises,Breathing Exercises, Bobath Exercises
Intervention Description
The puckered lip breathing exercise aims to prevent the closure of the small airways by creating pressure during expiration. During the exercise, the individual is asked to follow these steps: Breathe calmly and slowly through the nose. Pucker the lips as if whistling or inflating a balloon. Exhale the breath with puckered lips. Relaxation exercises Progressive Muscle Relaxation Technique: Progressive muscle relaxation is one of the easiest methods to learn and apply, developed by Jacobson. It involves voluntarily tensing and relaxing large muscle groups regularly and sequentially. The participant was encouraged to wear comfortable clothing, breathe deeply, and exhale. The technique can be performed in a sitting or lying position. Music can be played to contribute to the participant's relaxation.
Primary Outcome Measure Information:
Title
Sleep quality assessment
Description
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.
Time Frame
30 min
Title
Depression assessment
Description
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
Time Frame
30 min
Title
Spasticity assessment
Description
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.
Time Frame
15 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Istanbul Aydın University
City
Istanbul
ZIP/Postal Code
34900
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Investigation Of Two Different İnterventions İn Hemiplegic Patients

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