NCT05601934

Brief Summary

Hemiplegia is a disease with many complications in its clinical course. One of these complications is respiratory dysfunction. It is aimed to determine the respiratory function problems of patients with hemiplegia and to eliminate the problems by using neurophysiological facilitation techniques. Restrictive and obstructive pulmonary dysfunction occurs in hemiplegic patients. Decreased movement in the thorax, decreased respiratory muscle strength, changes in muscle tone, and changes in the central nervous system cause restrictive respiratory disorders. A significant decrease is observed in FEV1(Forced Expiratory Volume in One Second), FEV1%, FVC(Forced Vital Capacity), FVC% values. Alveolar ventilation is maintained through the central nervous system. For alveolar ventilation, the brain must transmit the impulse of breathing to the muscles through the spinal cord and peripheral nervous system. Lesions occurring in any part of the central nervous system affect respiratory functions. Hemiplegia is a condition that affects the movement of the diaphragm. During quiet breathing, there is a significant decrease in the movement of the diaphragm. Chest expansion is reduced. In a study, it was reported that neuromuscular facilitation techniques increase short-term ventilation and are reliable techniques for people with neurological damage. When we look at the literature, there is no study showing the effects of neurophysiological facilitation techniques on respiration in hemiplegic patients. The aim of our study; To determine the effects and safety of neurophysiological facilitation techniques in terms of pulmonary function, respiratory muscle strength, functional capacity and quality of life in hemiplegic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 24, 2022

Last Update Submit

October 28, 2022

Conditions

Keywords

Stroke, Respiratory, Physiotherapy and Rehabilitation, Neurophysiological Facilitation Techniques, Exercise

Outcome Measures

Primary Outcomes (2)

  • Inspiratory and/or expiratory muscle strength

    Neurophysiological facilitation techniques increases inspiratory muscle strength and causes decrease in dyspnea especially in the acute period.

    6 months

  • Positive Effect of Neurophysiological Facilitation Techniques on Pulmonary Stroke Patients

    Neurophysiological facilitation techniques that have positive effects in patients practice by physiotherapists should be encouraged.

    6 months

Secondary Outcomes (1)

  • Complications

    6 months

Study Arms (2)

Neurophysiological Facilitation Techniques

EXPERIMENTAL
Other: Neurophysiological Facilitation Techniques

Respiratory exercises

EXPERIMENTAL
Other: Neurophysiological Facilitation Techniques

Interventions

Increased enlargement of the ribs during inspiration and increased movement in the epigastric region and tone of the abdominal muscles also decreased respiratory rate are some of the changes that occur after these stimuli. In addition to these, involuntary increase in cough, sputum production also decrease in pathological sounds felt on auscultation, decrease in aspiration requirement, rapid return in chest wall stabilization and improvement in respiratory pattern can be observed after application with this application, positive and long-term effective results can be seen in a short time.

Also known as: Respiratory exercises
Neurophysiological Facilitation TechniquesRespiratory exercises

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 40 years
  • Stroke Patients

You may not qualify if:

  • Active Smokers
  • Thoracal Scoliosis Patients
  • Chest Deformity Patients
  • Traumatic Injuries in the Chest
  • Pneumonia,COPD(Chronic obstructive pulmonary disease)
  • Mini-Mental State Under 15 Points

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Home

Istanbul, Üsküdar, 34674, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HemiplegiaStrokeMotor Activity

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

October 24, 2022

First Posted

November 1, 2022

Study Start

June 21, 2020

Primary Completion

June 21, 2021

Study Completion

June 21, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations