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Completed

NCT Number: NCT04473872

Effects of Respiratory Physiotherapy on Postural Control, Balance, Respiratory Functions and Respiratory Muscle Strength

The aim of our study is to determine the effect of respiratory physiotherapy applied on stroke diagnosis, balance, respiratory functions and respiratory muscle strength in addition to neurodevelopmental treatment in patients with stroke.

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Key information

Conditions

Stroke Patients

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırıkkale University

Kirikkale, 71300, Turkey (Türkiye)

About this study

Our study will include individuals aged 40-75 years, diagnosed with ischemic or hemorrhagic stroke, who applied to the Kırıkkale University Faculty of Medicine physical therapy and rehabilitation clinic. After the patients are separated according to the specified exclusion and inclusion criteria, they will be divided into 3 groups using the "Online Random Allocation Software" program. Evaluations will be made before and after treatment.

In addition to normal neurodevelopmental therapy (NGT) 5 days a week, respiratory physiotherapy will be applied. The total duration of treatment will take 6 weeks.

  • Neurodevelopmental treatment program (BOBATH treatment approach) will be applied to the group.
  • The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and diaphragmatic breathing exercises.
  • The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and respiratory muscle training with the THRESHOLD IMT device.

Inspiratory Muscle Training Program with Threshold IMT device: Constant pressure is applied to the inspiration phase during application. The training group is started from 40% of MIP and inspiratory muscle training is given. In practice, patients are asked to sit in a loose position on the upper chest and shoulders. After the nose clip is attached, the patient is instructed to tighten his lips around the mouthpiece of the instrument, making inspiration and expiration. After eight breathing cycles, she is asked to do 1-2 respiratory controls.

Diaphragmatic breathing exercise: The patient is given a supine position, a pillow is placed under his knees and head. The patient is asked to place his right hand in the upper abdomen and his left hand in the upper part of his chest. The patient is told to take a slow and deep breath through the nose until four counts, and to hold the air in for the breathing time, and then to the patient, shrinking his lips like a whistle, and exhaling his breath for a long time. Exercises are performed two hours after meals, initially as short as 2-3 minutes, within 10 minutes of the patient's tolerance, with an average of 30 minutes per day.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being over 40 years old,
  • Stroke diagnosis,
  • The Mini-mental test score is above 23

Exclusion criteria

  • Other neurological or orthopedic problems that affect functionality and balance, other than stroke
  • High blood pressure, heart disease which may prevent rehabilitation
  • Patients with pulmonary disease (COPD)
  • Have undergone thoracic or cardiovascular surgery
  • Agnosia or a person with visual impairment,
  • Patients with epilepsy,
  • The medical condition is not stable,
  • Patients with reluctance towards treatment,
  • Patients with communication problem,
  • An area under 23 points from the Minimental Test,
  • Patients with peripheral nerve injury before stroke

Treatment and study plan

respiratory rehabilitation

Other

intervention includes respiratory muscle strengthening with diaphragmatic respiration and IMT device, in addition to neurodevelopmental rehabilitation.

Primary outcomes

  1. Mini-Mental State Test

    Time frame: 15 minutes

    It was used to determine the cognitive state before the training. The Mini-Mental State Test was first published by Folstein et al. It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points. The ideal threshold value of the Mini-Mental State Test was found to be 24.

  2. Time Up and Go Test

    Time frame: 5 minutes

    This test is applied to assess the risk of falling and mobility.This test starts with the individual leaving the chair without receiving arm support by giving the go command while sitting in a chair.The distance of 3 meters is asked to return and sit again in the chair.The elapsed time is recorded in seconds.

  3. Berg Balance Scale

    Time frame: 15 minutes

    It is a 14-item scale that evaluates the tasks used in daily life activities.Standing up without support, standing without support, sitting without support, standing up, transfers, standing with feet, standing with legs while standing, reaching out while standing, picking up from the ground, looking back, 360 degree rotation, firm side standing on the stool, one foot standstill and standstill functions are evaluated.Each item is planned between 0-4; 0 is unable to fulfill the task, 4 is to fulfill the task successfully. The total score of the test is between 0-56.0-20 points: wheelchair dependent, 21-40: assisted walking, 41-56: means independent ambulation.

  4. Trunk Impairment Scale

    Time frame: 5 minutes

    Evaluate the motor loss in trunk after stroke.It is a scale consisting of 17 items.3 items assess the static sitting balance, dynamic balance with 10 items, coordination with 4 items.The score is 0-23.The highest score is considered the best performance.

  5. Functional Reach Test

    Time frame: 5 minutes

    Subjects will asked to stand comfortably, to make a fist, and to raise their arm until it was parallel to the yardstick (position 1). The placement of the end of the third metacarpal along the yardstick will recorded. Subjects will then asked to reach as far forward as they could without losing their balance (position 2), and the position of the end of the third metacarpal along the yardstick will again recorded. No attempt will make to control the subject's method of reach, but if he will touch the wall or took a step during the maneuver, that trial will consider invalid and repeated

  6. Respiratory function test

    Time frame: 5 minutes

    Respiratory function test measurements were made according to the criteria of the spirometer (BTL-08 Spiro Pro system, Germany) ATS. The best of the three consecutive measurements were recorded. After respiratory function tests, Forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF) values were recorded in liters.

  7. Inspiratory and expiratory muscle strength

    Time frame: 5 minutes

    Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values were measured using the electronic mouth pressure measuring device (Pocket-Spiro MPM100 M, Bruxelles). As indicated by Black and Hyatt, MIP was measured in residual volume and MEP total lung capacity. Measurements were made 3 times and the best measurement was recorded

  8. Six minute walk test

    Time frame: 10 minutes

    The functional capacity of individuals was evaluated with 6MWT. The measurements were made in line with the recommendations of the American Thoracic Society. Individuals were asked to walk in the 30-meter corridor for six minutes at their walking speed, but as far as possible. During the test, individuals were allowed to stop and rest. The test was repeated twice daily. Highest 6 minutes walking distance recorded in meters

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study title

Effects of Respiratory Physiotherapy Applied to Neurodevelopmental Treatment on Postural Control, Balance, Respiratory Functions and Respiratory Muscle Strength in Stroke Patients

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2020
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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