Investigation Of Two Different İnterventions İn Hemiplegic Patients

NCT ID: NCT06084273

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2021-12-30

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.

Conditions

Stroke; Physiotherapy and Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Bobath Exercises

Bobath Exercises

Group Type: EXPERIMENTAL

Bobath Exercises

Intervention Type: 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

Breathing Exercises,Breathing Exercises, Bobath Exercises

Group Type: EXPERIMENTAL

Bobath Exercises

Intervention Type: 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

Intervention Type: 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:

1. Breathe calmly and slowly through the nose.

2. Pucker the lips as if whistling or inflating a balloon.

3. 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.

Interventions

Bobath Exercises

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

Breathing Exercises,Breathing Exercises, Bobath Exercises

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:

1. Breathe calmly and slowly through the nose.

2. Pucker the lips as if whistling or inflating a balloon.

3. 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Derya Azim

OTHER

Sponsor Role: lead

Responsible Party

Derya Azim

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Istanbul Aydın University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

06.04/58

Identifier Type: -

Identifier Source: org_study_id