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Completed

NCT Number: NCT06084273

Investigation Of Two Different İnterventions İn Hemiplegic Patients

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.

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Key information

Conditions

Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Motor Activity Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Physiotherapy and Rehabilitation Signs and Symptoms Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Aydın University

Istanbul, 34900, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bobath Exercises

Other

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.

Breathing Exercises,Breathing Exercises, Bobath Exercises

Other

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 outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Derya Azim

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 16, 2023
Registry last updated
Oct 16, 2023

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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