NCT04503499

Brief Summary

Neurological problems both lead to many respiratory problems primarily and events secondary to neurological diseases or symptoms can be the cause of respiratory failure. The addition of respiratory failure will adversely affect the course of the neurological picture, making treatment more difficult. The cardiopulmonary functions of hemiplegia patients decrease due to the decrease in the expansion of the thoracic part on the hemiplegic side and insufficient respiratory muscles. In addition, common symptoms in stroke patients, including limited use of ankylosis and muscle movements, cause oxygen deficiency and increased metabolic demands. After stroke, thoracic expansion is reduced upon paralysis of the diaphragm and respiratory muscles. Continuation of this condition can lead to muscle fibrosis. As a result, the level of thoracic expansion decreases during breathing. A decrease in thoracic spine mobility correlates with a decrease in forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1). The increase in the rigidity of the chest wall affects the ventilator pumping mechanism, reducing the level of rigidity (increasing the mobility of the chest wall) is recommended as a way to improve lung function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

July 28, 2020

Last Update Submit

November 2, 2023

Conditions

Keywords

pulmonary functionmanual therapyrespiratory function test

Outcome Measures

Primary Outcomes (11)

  • Chest circumference measurement

    Chest circumference measurement will be measured from the axillary (3rd costa), epigastric (xiphoid) and subcostal (mid xiphoid-umbilicus) areas, and measuring will be done by tape measure in inspiration and expiration.

    4 weeks

  • Forced expiratory volume

    Forced expiratory volume will be performed in a sitting position using a portable spirometer (Spirobank; Medical International Research, Rome, Italy) according to the American Thoracic Society rules. Participants will rest before the test to prevent fatigue. While the patient is sitting in a comfortable position on the chair, his nose will be closed with a clip and the mouthpiece will be placed and the measurement will be made. The patient will be asked to perform deep and long-term expiration after deep and severe inspiration after performing calm breathing three times. The measurement will be repeated three times.

    4 weeks

  • Forced vital capacity

    Forced vital capacity will be performed in a sitting position using a portable spirometer (Spirobank; Medical International Research, Rome, Italy) according to the American Thoracic Society rules. Participants will rest before the test to prevent fatigue. While the patient is sitting in a comfortable position on the chair, his nose will be closed with a clip and the mouthpiece will be placed and the measurement will be made. The patient will be asked to perform deep and long-term expiration after deep and severe inspiration after performing calm breathing three times. The measurement will be repeated three times.

    4 weeks

  • Forced expiratory volume / Forced vital capacity

    Forced expiratory volume / Forced vital capacity test will be performed in a sitting position using a portable spirometer (Spirobank; Medical International Research, Rome, Italy) according to the American Thoracic Society rules. Participants will rest before the test to prevent fatigue. While the patient is sitting in a comfortable position on the chair, his nose will be closed with a clip and the mouthpiece will be placed and the measurement will be made. The patient will be asked to perform deep and long-term expiration after deep and severe inspiration after performing calm breathing three times. The measurement will be repeated three times.

    4 weeks

  • Peak Expiratory Flow

    Peak Expiratory Flow test will be performed in a sitting position using a portable spirometer (Spirobank; Medical International Research, Rome, Italy) according to the American Thoracic Society rules. Participants will rest before the test to prevent fatigue. While the patient is sitting in a comfortable position on the chair, his nose will be closed with a clip and the mouthpiece will be placed and the measurement will be made. The patient will be asked to perform deep and long-term expiration after deep and severe inspiration after performing calm breathing three times. The measurement will be repeated three times.

    4 weeks

  • Maximal Expiratory Pressure

    Maximal expiratory pressure will be assessed using an electronic pressure transducer (MicroRPM; Micro Medical Ltd., Kent, UK). It will be measured according to maximal expiratory pressure Black and Hyatt. In Maximal Expiratory Pressure measurement from the patient; After doing maximal inspiration in a comfortable sitting position, his nose will be closed with a clip and he will be asked to make maximum expiration from the mouthpiece. The measurements will be repeated three times and the highest values will be recorded.

    4 weeks

  • Maximal Inspiratory Pressure

    Maximal inspiratory pressure will be assessed using an electronic pressure transducer (MicroRPM; Micro Medical Ltd., Kent, UK). It will be measured according to Maximal Inspiratory Pressure Black and Hyatt. From the patient in Maximal Inspiratory Pressure measurement; the patient is in a comfortable sitting position, after making maximum expiration, his nose will be closed with the help of a clip and he will be asked to make maximum inspiration from the mouthpiece.

    4 weeks

  • Respiratory Muscle Endurance

    Respiratory muscle endurance measurement will be performed with the Power Breath (HaB International Ltd. Southam, UK) portable device. Power Breath resistance will be adjusted by taking 60% of the maximal inspiratory pressure. The test time will be calculated and recorded in seconds. Power Breath resistance is adjusted in a comfortable sitting position, the clip will be recorded while the clip is attached to the nose and the mouthpiece of the device is inhaled.

    4 weeks

  • Oxygen Saturation

    Pulse oximetry device will measure oxygen saturation. Values before and after treatment will be measured and recorded.

    4 weeks

  • Heart Rate

    Pulse oximetry device will measure heart rate. Values before and after treatment will be measured and recorded.

    4 weeks

  • Respiratory Frequency

    Pulse oximetry device will measure respiratory frequency. Values before and after treatment will be measured and recorded.

    4 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

The group to which the manuel therapy will be applied.

Other: Manuel Therapy

Control Group

NO INTERVENTION

The control group where only the evaluations will be made.

Interventions

The manual therapy protocol will consist of 45-60 minutes and the following techniques; * suboccipital decompression * cervical mobilization (in the posterior-anterior direction) * sternocleidomastoid release * scalene release * trapezoidal release * scalene release * pectoralis tractus * sternoclavicular joint mobilization * sternum mobilization * parasternal circumference intercostal and paravertebral release * diaphragm release * rib reasing * scapulothoracic joint mobilization * thoracic vertebra mobilization Myofascial release techniques will be applied for 3-5 minutes each. Mobilization techniques were applied in each joint for 30 seconds and 5 times.

Study Group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 45-65 years old
  • Stage 4-6 according to Brunnstrom
  • According to Modified Ashworth, the upper extremity is at most two values
  • Sufficient to answer the level of consciousness survey
  • No smoking
  • No hearing or vision loss

You may not qualify if:

  • Not being able to read and write
  • Having cognitive impairment
  • Hearing difficulties and vision loss
  • Having any acute pain
  • Acute Bronchitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Okan University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, PhD, Associate Professor

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 7, 2020

Study Start

September 15, 2018

Primary Completion

July 15, 2019

Study Completion

August 15, 2019

Last Updated

November 3, 2023

Record last verified: 2023-11

Locations