Relationship Between Respiratory Muscle Strength, Balance, Trunk Control, Functional Capacity in Stroke Patients

Recruiting

• Conditions: Stroke Patients

• Registration Number: NCT06259877
• Lead Sponsor: Kırıkkale University

Brief Summary

The purpose of this study; To determine the relationship between respiratory muscle strength, balance, trunk control, functional capacity and motor functions in stroke patients and compare them with healthy individuals.

Detailed Description

Stroke is one of the most important causes of chronic disability in adults. Hemiplegia and hemiparesis are common neurological conditions following stroke. Neurological findings associated with hemiplegia negatively affect posture, muscle tone, motor control, voluntary motor activation and trunk muscle synergy. The effect of stroke on the respiratory system depends on the structures affected by the lesion. The continuation of normal ventilation also depends on the influence of the neuromuscular system. The interference in trunk muscle synergies brings about loss of respiratory muscle function. Symptoms associated with respiratory problems, especially dyspnea, reduce exercise performance. On the other hand, motor control function losses; It disrupts the coordination of the respiratory muscles and changes the thickness of the diaphragm muscle, causing asymmetry between the affected and unaffected sides. Developing asymmetry can lead to progressive loss of strength in the respiratory muscles.

In the evaluation of stroke patients, measurements of the pulmonary system are rarely included. It is thought that the fact that patients do not have symptoms and/or diseases related to the pulmonary system before the development of stroke may explain the insufficient attention to respiratory evaluations. However, in a few studies, respiratory system evaluations were also made in stroke patients; It has been reported that there are effects related to pulmonary functions such as partial or total diaphragm on the affected side and weakening of intercostal and abdominal muscles.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-27
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-06-20
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Stroke individuals over the age of 18

Exclusion Criteria

• Patients with another neurological problem (Parkinson, Multiple sclerosis, etc.) that will affect functionality and balance other than stroke
• Patients with orthopedic problems (short limbs, spine and lower extremity surgery) with pulmonary disease
• Patients with cooperation and communication problems

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trunk Impairment Scale	5 minutes	Developed to evaluate trunk balance (control) in patients with neurological deficits, GDS consists of 17 parameters. It evaluates static (3 parameters and 7 points in total) and dynamic (10 parameters, 10 points in total) sitting balance and trunk coordination (4 parameters, 6 points in total). The Trunk Impairment Scale is scored out of 2 and 3 points. The total score can be a minimum of 0 and a maximum of 23 points.
6 Minute Walk Test	10 minutes	It has been used to evaluate physical activity and functional capacity in many pulmonary rehabilitation programs for patients with chronic pulmonary disease and limited respiratory capacity. 6MWT is a simple, low-cost test that monitors blood pressure (BP), heart rate (HR), respiratory frequency (SF), pulse oxygen saturation (SpO2), Borg Scale score and distance walked. This test allows determination of physical fitness and VO2max and also evaluates the patient's capacity and exercise tolerance
Evaluation of Balance	5 minutes	Berg Balance Scale was designed to quantitatively evaluate balance and determine the risk of falling, and was preferred because it evaluates people's ability to maintain their balance while performing functional activities. BBS consists of 14 items for direct observation of maintaining body balance during performance. Each item is scored between 0-4 depending on the patient's ability to meet the specific time and distance requirements for the test. In the test, which is made more difficult by reducing the support base, a score of 4 indicates the ability to complete the task independently and a score of 0 indicates an inability to initiate the task. The test measures the level of dependence and/or independence and the person's ability to change positions during positions such as standing from sitting to standing, standing with feet together, standing in tandem position, balancing on one leg.
The Stroke Rehabilitation Assessment Of Movement Scale	5 minutes	STREAM is a scale used for clinical motor assessment in stroke patients. This scale consists of 3 parts, each consisting of 10 items: upper extremity voluntary movement, lower extremity voluntary movement and basic mobility. There are 30 sub-items in total. Scoring should be done separately for voluntary movements and basic mobility. Points are given according to the quality of the movement and the amount of execution.
Functional reach test	5 minutes	It is used to measure the stability limits of patients. For the test, the patient is asked to raise his unaffected arm forward 90° and make a fist with his hand, and to reach forward as much as he can by following the meter placed at shoulder level, without any loss of movement or balance in the feet, and the distance between the first and last measurement is measured by taking the 3rd Metacarpolaryngeal joint as a criterion. The test was repeated 3 times and the average value was recorded in cm.
Evaluation of respiratory functions	5 minutes	Measurements will be made in a sitting position using a spirometer (BTL-08 Spiro Pro system, Germany). Measurements are carried out in accordance with the recommendations of ATS (American Thoracic Society). The best of three consecutive measurements in each case is recorded. After respiratory function tests, FEV1, FVC, FEV1/FVC and PEF values are recorded. Pulmonary function test parameters are expressed as a percentage of expected values according to age, height, body weight and gender. Evaluations will be made by a physiotherapist experienced in Cardiopulmonary Rehabilitation.
Respiratory Muscle Strength Measurement	5 minutes	Respiratory muscle strength will be measured using a portable, electronic mouth pressure measuring device (MEC Pocket Spiro MPM100, Belgium). One of the most frequently used and non-invasive methods for evaluating respiratory muscles is the measurement of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). These are the intraoral pressures measured during maximal inspiration and expiration against a valve that closes the respiratory tract. MIP is the pressure (in effect negative pressure) created to open closed alveoli at the highest level of residual volume. The person being tested is made to take maximum inspiration, and at the end of this, the respiratory tract is closed with a valve and the person is asked to take maximum inspiration and continue this for 1-3 seconds.In MEP measurement, the person is asked to perform maximal inspiration against the closed airway for 1-3 seconds after maximal inspiration.

Trial Locations

Locations (1)

Kirikkale University; 🇹🇷 Kırıkkale, Turkey