Investigation Of Two Different İnterventions İn Hemiplegic Patients

Not Applicable

Completed

• Conditions: Stroke; Physiotherapy and Rehabilitation
• Interventions: Other: Bobath Exercises; Other: Breathing Exercises,Breathing Exercises, Bobath Exercises

• Registration Number: NCT06084273
• Lead Sponsor: Derya Azim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breathing Exercises,Breathing Exercises, Bobath Exercises	Bobath Exercises	Breathing Exercises,Breathing Exercises, Bobath Exercises
Bobath Exercises	Bobath Exercises	Bobath Exercises
Breathing Exercises,Breathing Exercises, Bobath Exercises	Breathing Exercises,Breathing Exercises, Bobath Exercises	Breathing Exercises,Breathing Exercises, Bobath Exercises

Primary Outcome Measures

Name	Time	Method
Sleep quality assessment	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	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	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

Trial Locations

Locations (1)

Istanbul Aydın University; 🇹🇷 Istanbul, Turkey