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

Primary Purpose

Stroke Patients

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
respiratory rehabilitation
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Patients focused on measuring respiratory rehabilitation, balance, Postural Control, Respiratory Functions, Respiratory Muscle Strength

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kırıkkale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Neurodevelopmental treatment program group

diaphragmatic breathing

respiratory muscle training with the THRESHOLD IMT device

Arm Description

When applying NGT, which is described as a problem solving approach, the treatment program appropriate for their functional levels will be determined for each patient, taking into account the individual needs and wishes of the patient. Principles to be considered while applying the treatment program: Inhibition of normal / ineffective movements Facility of normal / effective movements Sensory-motor stimulation Correct placement of body segments Neurodevelopmental treatment physiotherapy session for 5-days in a week, over 6-week. Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.

The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and diaphragmatic breathing exercises. Diaphragmatic breathing; To give the patient a supine position, a pillow is placed under his knees and head. The patient is asked to place his right hand on the upper abdomen and his left hand on 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 time it has inhaled, and then the patient shrinks her lips like a whistle and exhales from using her breath for a long time. Exercises are performed two hours after meals, in short, 2-3 minutes in the beginning, in 10 of the patients, on average 30 minutes per day.

The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and respiratory muscle training with the THRESHOLD IMT device. T-IMT is an instrument that provides the same pressure in each breath for the strength and endurance of the inspiratory muscles, regardless of the patient's rapid or slow breathing. This device provides a constant pressure in inspiration with its flow-free one-way valve. It also has an adjustable device pressure. The tool consists of pressure section, mouthpiece and nose clip. During application, constant pressure is applied to the inspiration phase. 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 eight breathing cycles, 1-2 respiratory controls are requested

Outcomes

Primary Outcome Measures

Mini-Mental State Test
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.
Time Up and Go Test
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.
Berg Balance Scale
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.
Trunk Impairment Scale
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.
Functional Reach Test
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
Respiratory function test
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.
Inspiratory and expiratory muscle strength
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
Six minute walk test
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

Secondary Outcome Measures

Full Information

First Posted
July 13, 2020
Last Updated
March 7, 2023
Sponsor
Kırıkkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04473872
Brief Title
Effects of Respiratory Physiotherapy on Postural Control, Balance, Respiratory Functions and Respiratory Muscle Strength
Official Title
Effects of Respiratory Physiotherapy Applied to Neurodevelopmental Treatment on Postural Control, Balance, Respiratory Functions and Respiratory Muscle Strength in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
July 13, 2020 (Actual)
Study Completion Date
August 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patients
Keywords
respiratory rehabilitation, balance, Postural Control, Respiratory Functions, Respiratory Muscle Strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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. 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurodevelopmental treatment program group
Arm Type
Active Comparator
Arm Description
When applying NGT, which is described as a problem solving approach, the treatment program appropriate for their functional levels will be determined for each patient, taking into account the individual needs and wishes of the patient. Principles to be considered while applying the treatment program: Inhibition of normal / ineffective movements Facility of normal / effective movements Sensory-motor stimulation Correct placement of body segments Neurodevelopmental treatment physiotherapy session for 5-days in a week, over 6-week. Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
Arm Title
diaphragmatic breathing
Arm Type
Experimental
Arm Description
The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and diaphragmatic breathing exercises. Diaphragmatic breathing; To give the patient a supine position, a pillow is placed under his knees and head. The patient is asked to place his right hand on the upper abdomen and his left hand on 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 time it has inhaled, and then the patient shrinks her lips like a whistle and exhales from using her breath for a long time. Exercises are performed two hours after meals, in short, 2-3 minutes in the beginning, in 10 of the patients, on average 30 minutes per day.
Arm Title
respiratory muscle training with the THRESHOLD IMT device
Arm Type
Experimental
Arm Description
The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and respiratory muscle training with the THRESHOLD IMT device. T-IMT is an instrument that provides the same pressure in each breath for the strength and endurance of the inspiratory muscles, regardless of the patient's rapid or slow breathing. This device provides a constant pressure in inspiration with its flow-free one-way valve. It also has an adjustable device pressure. The tool consists of pressure section, mouthpiece and nose clip. During application, constant pressure is applied to the inspiration phase. 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 eight breathing cycles, 1-2 respiratory controls are requested
Intervention Type
Other
Intervention Name(s)
respiratory rehabilitation
Intervention Description
intervention includes respiratory muscle strengthening with diaphragmatic respiration and IMT device, in addition to neurodevelopmental rehabilitation.
Primary Outcome Measure Information:
Title
Mini-Mental State Test
Description
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.
Time Frame
15 minutes
Title
Time Up and Go Test
Description
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.
Time Frame
5 minutes
Title
Berg Balance Scale
Description
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.
Time Frame
15 minutes
Title
Trunk Impairment Scale
Description
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.
Time Frame
5 minutes
Title
Functional Reach Test
Description
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
Time Frame
5 minutes
Title
Respiratory function test
Description
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.
Time Frame
5 minutes
Title
Inspiratory and expiratory muscle strength
Description
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
Time Frame
5 minutes
Title
Six minute walk test
Description
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
Time Frame
10 minutes

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saniye Aydoğan Arslan
Organizational Affiliation
Kırıkkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kırıkkale University
City
Kırıkkale
ZIP/Postal Code
71300
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18463551
Citation
Ryerson S, Byl NN, Brown DA, Wong RA, Hidler JM. Altered trunk position sense and its relation to balance functions in people post-stroke. J Neurol Phys Ther. 2008 Mar;32(1):14-20. doi: 10.1097/NPT.0b013e3181660f0c.
Results Reference
background
PubMed Identifier
27216224
Citation
Gomes-Neto M, Saquetto MB, Silva CM, Carvalho VO, Ribeiro N, Conceicao CS. Effects of Respiratory Muscle Training on Respiratory Function, Respiratory Muscle Strength, and Exercise Tolerance in Patients Poststroke: A Systematic Review With Meta-Analysis. Arch Phys Med Rehabil. 2016 Nov;97(11):1994-2001. doi: 10.1016/j.apmr.2016.04.018. Epub 2016 May 20.
Results Reference
result
PubMed Identifier
32050421
Citation
Ramos SM, Silva DMD, Buchaim DV, Buchaim RL, Audi M. Evaluation of Respiratory Muscular Strength Compared to Predicted Values in Patients with Stroke. Int J Environ Res Public Health. 2020 Feb 9;17(3):1091. doi: 10.3390/ijerph17031091.
Results Reference
result
PubMed Identifier
32493056
Citation
Zhang X, Zheng Y, Dang Y, Wang L, Cheng Y, Zhang X, Mao M, Lu X. Can inspiratory muscle training benefit patients after stroke? A systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2020 Jul;34(7):866-876. doi: 10.1177/0269215520926227. Epub 2020 Jun 3.
Results Reference
result

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

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