StrokeNCT07725471
COMPARISON OF BREATHING AND SUBOCCIPITAL RELEASE IN STROKE
A study testing Breathing Exercise, Suboccipital Release and Standard treatment in people with Stroke, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the positive effects of deep, slow breathing exercises and suboccipital relaxation, when added to a routine physiotherapy and rehabilitation program, on autonomic, motor, cognitive, and emotional status functions in individuals who have experienced a stroke, and to examine their… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Stroke
- What is being tested?
- Breathing Exercise, Suboccipital Release and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2026to 30 Sep 2027
- Phase
- Interventional
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 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time diagnosis of stroke
- Presence of unilateral hemiplegia due to ischemic or hemorrhagic stroke etiology
- Presence of hemiparesis
- At least 3 months post-stroke
- Having signed the informed consent form
- Aged between 18 and 84 years
Who cannot join
- Presence of active or chronic respiratory disease
- Low heart rate (<60 bpm)
- Known cardiac conduction disorder
- Symptomatic carotid or vertebrobasilar stenosis
- Severe carotid or vertebrobasilar stenosis
- Advanced liver, kidney, heart, or lung disease
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- Diagnosed depression
- Pregnancy
- Severe aphasia or cognitive impairment that may interfere with the informed consent process or study procedures
- Malignant tumors or infectious diseases
- Presence of a pacemaker or other implanted electrical device
- Spasticity of grade 4 or higher according to the Modified Ashworth Scale in the upper and lower extremities
- Brunnstrom Motor Staging below stage 3 in the upper and lower extremities
- Failure to meet the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University Health Practice and Research Center
Afyonkarahisar, 03000
Nuran EYVAZ, +905334262442, nuran.eyvaz@afsu.edu.tr
Zeynep Arikan, +905536655775, zeynepcikar61@gmail.com
About this study
Official title: COMPARISON OF THE EFFECTS OF DEEP AND SLOW BREATHING EXERCISES AND SUBOCCIPITAL RELEASE, ADDED TO ROUTINE PHYSIOTHERAPY AND REHABILITATION, ON AUTONOMIC, MOTOR, AND COGNITIVE FUNCTIONS AND EMOTIONAL STATUS IN STROKE PATIENTS
The aim of this study is to investigate the positive effects of deep, slow breathing exercises and suboccipital relaxation, when added to a routine physiotherapy and rehabilitation program, on autonomic, motor, cognitive, and emotional status functions in individuals who have experienced a stroke, and to examine their superiority compared to routine physiotherapy and rehabilitation alone.
Read the detailed description
Deep, slow breathing exercises have been reported in the literature to positively affect lung function, balance, and gait. Studies have also shown that slow and deep breathing can improve cognitive function. Current evidence indicates that these exercises significantly enhance baroreflex function, heart rate variability (HRV), and blood pressure regulation, as well as improve sleep quality and emotional conditions such as stress, anxiety, and depression.
Suboccipital relaxation has been identified as a beneficial therapeutic approach for improving balance and gait ability in individuals with chronic stroke. Additionally, cervical mobilization has been suggested as a supportive intervention in stroke rehabilitation. Suboccipital relaxation is noteworthy due to its potential to influence the parasympathetic nervous system, which plays a key role in regulating various bodily functions, including heart rate, digestion, and stress responses. Furthermore, the combined use of cervical joint mobilization and diaphragmatic breathing in individuals with chronic stroke has been reported to improve lung function and craniovertebral angle.
Although the literature reports positive effects of deep, slow breathing exercises and suboccipital relaxation individually, these methods have primarily been studied separately. To date, no study has evaluated their combined or comparative effects in stroke rehabilitation. In this respect, the present study is both clinically and methodologically novel. It aims to generate scientific evidence for multidimensional recovery processes after stroke, provide a theoretical and practical foundation for the development of comprehensive rehabilitation protocols, and ultimately contribute to reducing the global burden of stroke.
- Conditions
- Stroke
- Being tested
- Breathing Exercise, Suboccipital Release, Standard treatment
- Keywords
- Stroke, Breathing Exercises, Rehabilitation, Autonomic Nervous System, Heart Rate Variability
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExerciseOther
Individuals assigned to Group 1 will receive deep breathing exercises in addition to the hospital's routine physiotherapy and rehabilitation program, for a duration of 6 weeks, 3 days per week, with each session lasting 20 minutes. During the application of the breathing exercises, stroke patients will be positioned in a supine position, and the procedure will be conducted according to previously described protocols. The total 20-minute session will consist of breathing cycles with 4 seconds of inspiration and 6 seconds of expiration (6 breaths per minute). At the beginning, participants will be given verbal instructions and will be guided with visual cues during the exercise. Participants will be instructed to fully inflate their lungs during inspiration and completely empty their lungs during expiration. After the breathing exercise is taught, rest intervals will be provided as needed based on the patient's condition.
Suboccipital ReleaseOther
Individuals assigned to Group 2 will receive the hospital's routine physiotherapy and rehabilitation program. In addition, suboccipital release will be applied for 6 weeks, 3 days per week, with each session lasting 20 minutes. Before initiating the suboccipital release procedure, the patient will be positioned in a supine position, and the practitioner will be seated on a stool at the head of the bed. The bed will be adjusted so that the patient's head is at the level of the practitioner's abdomen, allowing the practitioner to perform the technique with approximately 90° of elbow flexion and proper ergonomics.
Once the patient is positioned comfortably and correctly, the practitioner will sit at the head of the bed and place both hands under the patient's head, in the occipital region. The practitioner will then palpate along the occipital ridge and gently move the hands inferiorly until muscle tissue is identified. Subsequently, the practitioner will flex the fingers upward toward t
Standard treatmentOther
Individuals assigned to Group 3 will receive only the hospital's routine physiotherapy and rehabilitation program. All participants will be included in this standard program, which consists of gait training, balance training, and upper extremity rehabilitation commonly applied to stroke patients. Under the supervision of a physiotherapist, patients will perform normal range of motion exercises in bed, upper extremity exercises in a sitting position, and functional activities such as walking, stair climbing, and ball throwing and catching while standing. This program will be standardized for all patients in terms of session frequency and duration, with each session lasting approximately 45-50 minutes according to the routine protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Breathing Exercise Group): | Experimental | Individuals assigned to Group 1 will receive deep breathing exercises in addition to the hospital's routine physiotherapy and rehabilitation program, for a duration of 6 weeks, 3 days per week, with each session lasting 20 minutes. During the application of the breathing exercises, stroke patients will be positioned in a supine position, and the procedure will be conducted according to previously described protocols. The total 20-minute session will consist of breathing cycles with 4 seconds of inspiration and 6 seconds of expiration (6 breaths per minute). At the beginning, participants will be given verbal instructions and will be guided with visual cues during the exercise. Participants will be instructed to fully inflate their lungs during inspiration and completely empty their lungs during expiration. After the breathing exercise is taught, rest intervals will be provided as needed based on the patient's condition. Receives: Other: Breathing Exercise; Other: Standard treatment |
| Group 2 (Suboccipital Release Group) | Experimental | Individuals assigned to Group 2 will receive the hospital's routine physiotherapy and rehabilitation program. In addition, suboccipital release will be applied for 6 weeks, 3 days per week, with each session lasting 20 minutes. Before initiating the suboccipital release procedure, the patient will be positioned in a supine position, and the practitioner will be seated on a stool at the head of the bed. The bed will be adjusted so that the patient's head is at the level of the practitioner's abdomen, allowing the practitioner to perform the technique with approximately 90° of elbow flexion and proper ergonomics.
Once the patient is positioned comfortably and correctly, the practitioner will sit at the head of the bed and place both hands under the patient's head, in the occipital region. The practitioner will then palpate along the occipital ridge and gently move the hands inferiorly until muscle tissue is identified. Subsequently, the practitioner will flex the fingers upward toward Receives: Other: Suboccipital Release; Other: Standard treatment |
| Group 3 (Control Group) | Other | Individuals assigned to Group 3 will receive only the hospital's routine physiotherapy and rehabilitation program. All participants will be included in this standard program, which consists of gait training, balance training, and upper extremity rehabilitation commonly applied to stroke patients. Under the supervision of a physiotherapist, patients will perform normal range of motion exercises in bed, upper extremity exercises in a sitting position, and functional activities such as walking, stair climbing, and ball throwing and catching while standing. This program will be standardized for all patients in terms of session frequency and duration, with each session lasting approximately 45-50 minutes according to the routine protocol. Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (HRV)
Heart Rate Variability (HRV) will be measured using the Polar H10 chest strap sensor. The device is placed below the chest and transmits data via Bluetooth to the Elite HRV mobile application.
The following HRV parameters will be recorded: RMSSD(Root Mean Square of Successive Differences), SDNN(Standard Deviation of Normal-to-Normal intervals), low-frequency (LF) power (ms²), and high-frequency (HF) power (ms²). RMSSD and HF reflect parasympathetic activity, while SDNN represents overall autonomic activity. LF reflects both sympathetic and parasympathetic activity but is mainly associated with sympathetic modulation. HF is influenced by respiration and increases during relaxation and deep breathing.
Measured: Baseline and after 6 weeks of intervention
Secondary outcomes (5)
Berg Balance Scale (BBS)
This test evaluates an individual's ability to maintain balance during functional activities. As the functional tasks progress, the base of support is reduced, increasing the level of difficulty. The assessed activities include sit-to-stand, standing unsupported, sitting unsupported, stand-to-sit, transfers, standing with eyes closed, standing with feet together, reaching forward while standing, picking up an object from the floor, turning to look behind, turning 360 degrees, placing one foot on a stool, tandem standing, and standing on one leg.
The test consists of 14 functional tasks, each scored on a scale from 0 (poor) to 4 (best performance). The maximum total score is 56, indicating optimal balance. Scores between 0-20 indicate a high risk of falling, 21-40 indicate a moderate risk, and 41-56 indicate a low risk.
Measured: Baseline and after 6 weeks of intervention
Motor Activity Log-28 (MAL-28)
The Motor Activity Log-28 (MAL-28) consists of two subscales that evaluate the use of the affected upper extremity during daily activities (e.g., opening a drawer, washing hands): the Amount of Use (AOU) scale and the Quality of Movement (QOM) scale. Participants are asked to rate themselves on a scale from 0 to 5 (0 = not used at all, 5 = used as frequently as before the stroke). The total score is calculated by dividing the sum of the item scores by the number of items. Higher scores indicate better frequency of use and quality of movement of the affected limb.
Measured: Baseline and after 6 weeks of intervention
Fugl-Meyer Assessment - Upper Extremity (FMA-UE):
The Fugl-Meyer Motor Assessment for the upper extremity is based on stages of motor recovery in stroke patients. It consists of 33 items evaluating the shoulder, elbow, forearm, wrist, and hand (grip function), as well as reflex activity, coordination, and speed. Each item is scored on a 3-point scale from 0 to 2: 0 = cannot perform, 1 = performs partially, and 2 = performs fully. The maximum possible score is 66.
Measured: Baseline and after 6 weeks of intervention
Montreal Cognitive Assessment (MoCA):
The MoCA is an easy-to-administer screening tool used to assess mild cognitive impairment, with an approximate administration time of 10 minutes. It includes subdomains evaluating attention, concentration, executive functions, memory, language, visual-structural skills, abstract thinking, calculation, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline and after 6 weeks of intervention
Beck Depression Inventory (BDI):
The Beck Depression Inventory is used to assess mood disorders. It consists of 21 items, each scored on a scale from 0 to 3. The maximum possible score is 63, with higher scores indicating more severe depressive symptoms.
Measured: Baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start6 Jul 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be conducted with stroke patients hospitalized in an inpatient clinic for a duration of 6 weeks. All participants will continue to receive routine medical treatment prescribed by a physician as well as the standard physiotherapy and rehabilitation program. Additional interventions will be applied at least 2 hours after the routine treatment. Participants will be allocated into three groups: Group 1: In addition to routine physiotherapy, participants will receive deep and slow breathing exercises for 20 minutes per session, 3 times per week, for 6 weeks (4 seconds of inspiration and 6 seconds of expiration, 6 breaths per minute). Group 2: In addition to routine physiotherapy, participants will receive suboccipital relaxation for 20 minutes per session, 3 times per week, for 6 weeks. Group 3: Participants will receive only the routine physiotherapy and rehabilitation program. The standard physiotherapy program will include range of motion exercises, balance training,
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bihter Aslanyurek, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725471
- Sponsor's protocol ID
- AYBU-FTR-ZA-01
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No