StrokeNCT06084273
Investigation Of Two Different İnterventions İn Hemiplegic Patients
A study testing Bobath Exercises and Breathing Exercises,Breathing Exercises, Bobath Exercises in people with Stroke and Physiotherapy and Rehabilitation, run by Derya Azim at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke, Physiotherapy and Rehabilitation
- What is being tested?
- Bobath Exercises and Breathing Exercises,Breathing Exercises, Bobath Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectıveness Of Relaxation And Respiratory Exercise On Sleep Quality, Depressıon And Spasticity In Hemiplegic Stroke Patients: Prelimınary Findings
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
- Being tested
- Bobath Exercises, Breathing Exercises,Breathing Exercises, Bobath Exercises
- Keywords
- Depression, Exercise, Relaxation, Pain
- Medical subject headings
- Stroke, Depression, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bobath ExercisesOther
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 ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Bobath Exercises | Experimental | Bobath Exercises Receives: Other: Bobath Exercises |
| Breathing Exercises,Breathing Exercises, Bobath Exercises | Experimental | Breathing Exercises,Breathing Exercises, Bobath Exercises Receives: Other: Bobath Exercises; Other: Breathing Exercises,Breathing Exercises, Bobath Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 min
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
Measured: 30 min
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.
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Nov 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derya Azim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Derya Azim, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084273
- Sponsor's protocol ID
- 06.04/58
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectıveness Of Relaxation And Respiratory Exercise On Sleep Quality, Depressıon And Spasticity In Hemiplegic Stroke Patients: Prelimınary Findings
- ClinicalTrials.gov ID
- NCT06084273
- Acronym / sponsor ID
- 06.04/58
- Conditions
- Stroke, Physiotherapy and Rehabilitation
- Keywords
- Depression, Exercise, Relaxation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Derya AzimUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bobath Exercises | Experimental | Other: Bobath ExercisesBobath Exercises |
| Breathing Exercises,Breathing Exercises, Bobath Exercises | Experimental | Other: Bobath Exercises, Other: Breathing Exercises,Breathing Exercises, Bobath ExercisesBreathing Exercises,Breathing Exercises, Bobath Exercises |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bobath ExercisesThe 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. | Other | Bobath Exercises, Breathing Exercises,Breathing Exercises, Bobath Exercises |
| Breathing Exercises,Breathing Exercises, Bobath ExercisesThe 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. | Other | Breathing Exercises,Breathing Exercises, Bobath Exercises |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bobath Exercises and Breathing Exercises,Breathing Exercises, Bobath Exercises in people with Stroke and Physiotherapy and Rehabilitation, run by Derya Azim at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality assessment (time frame: 30 min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.