Clinical trial NCT04473872: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Patients
Keywords: respiratory rehabilitation
balance
Postural Control
Respiratory Functions
Respiratory Muscle Strength
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.

1. Neurodevelopmental treatment program (BOBATH treatment approach) will be applied to the group.
2. The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and diaphragmatic breathing exercises.
3. The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and respiratory muscle training with the THRESHOLD IMT device.
Primary purpose: TREATMENT

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.

1. Neurodevelopmental treatment program (BOBATH treatment approach) will be applied to the group.
2. The group will have a neurodevelopmental treatment program (BOBATH treatment approach) and diaphragmatic breathing exercises.
3. 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.

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

Primary outcomes:
measure: Mini-Mental State Test
timeFrame: 15 minutes
measure: Time Up and Go Test
timeFrame: 5 minutes
measure: Berg Balance Scale
timeFrame: 15 minutes
measure: Trunk Impairment Scale
timeFrame: 5 minutes
measure: Functional Reach Test
timeFrame: 5 minutes
measure: Respiratory function test
timeFrame: 5 minutes
measure: Inspiratory and expiratory muscle strength
timeFrame: 5 minutes
measure: Six minute walk test
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University
Study officials:
affiliation: Kırıkkale University
name: Saniye Aydoğan Arslan
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.