COMPARISON OF BREATHING AND SUBOCCIPITAL RELEASE IN STROKE

NCT07725471 | Recruiting

• 1 other identifier: AYBU-FTR-ZA-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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 superiority compared to routine physiotherapy and rehabilitation alone.

Conditions

Stroke

Keywords

Stroke; Breathing Exercises; Rehabilitation; Autonomic Nervous System; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and after 6 weeks of intervention

Secondary Outcomes (5)

• Berg Balance Scale (BBS)

  Baseline and after 6 weeks of intervention

• Motor Activity Log-28 (MAL-28)

  Baseline and after 6 weeks of intervention

• Fugl-Meyer Assessment - Upper Extremity (FMA-UE):

  Baseline and after 6 weeks of intervention

• Montreal Cognitive Assessment (MoCA):

  Baseline and after 6 weeks of intervention

• Beck Depression Inventory (BDI):

  Baseline and after 6 weeks of intervention

Study Arms (3)

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.

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

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.

Other: Standard treatment

Interventions

Breathing Exercise OTHER

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.

Group 1 (Breathing Exercise Group):

Suboccipital Release OTHER

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

Group 2 (Suboccipital Release Group)

Standard treatment 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.

Group 1 (Breathing Exercise Group):; Group 2 (Suboccipital Release Group); Group 3 (Control Group)

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University Health Practice and Research Center

Afyonkarahisar, 03000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Zeynep Arikan

CONTACT

+905536655775; zeynepcikar61@gmail.com

Bihter Akinoğlu

CONTACT

+90 505 938 4136; bakinoglu@aybu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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,

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)