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

NCT ID: NCT04473872

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-08-03

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.

Conditions

Stroke Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neurodevelopmental treatment program group

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.

Group Type: ACTIVE_COMPARATOR

respiratory rehabilitation

Intervention Type: OTHER

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

diaphragmatic breathing

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.

Group Type: EXPERIMENTAL

respiratory rehabilitation

Intervention Type: OTHER

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

respiratory muscle training with the THRESHOLD IMT device

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

Group Type: EXPERIMENTAL

respiratory rehabilitation

Intervention Type: OTHER

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

Interventions

respiratory rehabilitation

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kırıkkale University

OTHER

Sponsor Role: lead

Responsible Party

Saniye Aydoğan Arslan

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saniye Aydoğan Arslan

Role: PRINCIPAL_INVESTIGATOR

Kırıkkale University

Locations

Kırıkkale University

Kırıkkale, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 18463551 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27216224 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32050421 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32493056 (View on PubMed)

Other Identifiers

RespiratoryPhysiotherapyStroke

Identifier Type: -

Identifier Source: org_study_id