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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05549518
Other study ID # 2015-KAEK-65-22-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date October 30, 2023

Study information

Verified date January 2024
Source Biruni University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A stroke due to a cerebrovascular accident (CVA) is a neurological deficit characterized by the rapid settlement of signs and symptoms due to focal or global loss of cerebral function, without any apparent cause other than vascular causes. Stroke is one of the most common cardiovascular events in the world. In addition to complications such as spasticity, loss of strength, balance problems, speech and swallowing problems, pulmonary complications are also common in stroke. When the literature is examined, there are a limited number of studies evaluating respiratory functions and functional capacity as a result of core stabilization exercises applied to stroke patients. There is no study in the literature examining the results of core stabilization exercises on respiratory functions, functional capacity, trunk control, and balance in stroke patients. The aim of this study; to investigate the effects of core stabilization training applied in addition to traditional physical therapy on respiratory functions, functional capacity, trunk control, and balance in stroke individuals after cerebrovascular accidents.


Description:

Stroke is a disease that requires rehabilitation practices beyond traditional medical treatments as an approach to managing diseases and complications over time. Physiotherapy and rehabilitation approaches include techniques such as joint range of motion exercises, muscle strengthening, stretching, balance-coordination exercises, neurophysiological approaches (PNF-Bobath), electrical stimulation, orthotic approaches, and breathing exercises. In stroke, especially the lower and upper extremities are emphasized, but trunk dysfunctions are also common. In stroke individuals, weakened trunk muscles cause postural instability, resulting in trunk control disorder, balance problems, and a decrease in physical activity. Decreased trunk control is also associated with decreased pulmonary function and functional capacity. Core Stabilization Exercises (CSE) have recently become a popular form of therapeutic exercise and also play a key role in functional outcomes in stroke individuals. Gradually progressing from easy to difficult, CSE is seen as a critical component of restoring appropriate kinetic function. It is also an exercise approach that aims to prevent compensatory movements, contribute to the motor relearning of inhibited muscles, and strengthen the diaphragm and other respiratory muscles, which are a component of core stability. The aim of this study; to investigate the effects of core stabilization training applied in addition to traditional physical therapy on respiratory functions, functional capacity, trunk control, and balance in stroke individuals after cerebrovascular accidents.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 30, 2023
Est. primary completion date October 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Cerebrovascular attack due to ischemia or hemorrhage - Over 18 years old and under 65 years old - Diagnosed with a cerebrovascular attack at least 3 months ago - A Mini-Mental State Test score of 24 or higher - Brunnstrom stage 3 or higher in the upper and lower extremities - 2 or less spasticity according to the Modified Ashworth Scale - Stage 2 or higher according to the Functional Ambulation Classification Exclusion Criteria: - Having a history of additional neurological diseases or disorders other than cerebrovascular attack - Cerebrovascular attack history more than once - Having musculoskeletal disorders - There are other treatments that may alter the effects of the interventions to be applied. - Having severe aphasia, amnesia, and agnosia - Having hearing or visual impairment - Failure to complete the 2 Minute Walking Test - Having a permanent pacemaker installed - Having a history of active malignancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Core stabilization + Traditional Physical Therapy
In addition to the traditional physical therapy training, core stabilization exercises will be applied 3 days a week for 6 weeks, and 20 minutes in each session under the supervision of a physiotherapist. Core stabilization exercises; will gradually progress from easy exercises to difficult ones. Exercises will be performed in supine, hook position, sitting position, on stable and mobile surfaces. Exercises will progress from 1 set to 3 sets, from 7 to 10 reps, contractions from 3 seconds to 10 seconds. All exercises will be performed with breathing control. The exercises will be progressed by gradually increasing them every week.
Traditional Physical Therapy
Traditional physical therapy training will be given for 40 minutes each session, 3 times a week for 6 weeks under the supervision of a physiotherapist. As a traditional physical therapy program, a rehabilitation program that increases mobility and daily living activities will be applied to patients. Joint range of motion exercises Stretching exercises Strengthening exercises Bobath-based neurophysiological approaches Task-oriented training 15 minutes of neuromuscular electrical stimulation (NMES) application

Locations

Country Name City State
Turkey Biruni University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tiffeneau ratio Spirometric assessment will be performed to determine participants' Tiffeneau ratio (Forced Expiratory Volume 1. second (FEV1)/ Forced Vital Capacity (FVC)). Change from Baseline Tiffeneau ratio at 6 weeks
Primary 2 Minutes Walking Test The 2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test. Change from Baseline 2 Minutes Walking Test at 6 weeks
Secondary Peak expiratory flow Spirometric assessment will be performed to determine participants' peak expiratory flow Change from Baseline Peak expiratory flow at 6 weeks
Secondary Chest mobility It is measured from the axillary, epigastric, and subcostal regions during inhalation and exhalation to assess chest expansion and mobility. Change from Baseline Chest mobility at 6 weeks
Secondary Trunk Impairment Scale It is used to assess the motor impairment levels of the trunk. It consists of a total of 17 items under 3 sub-headings: static sitting balance, dynamic sitting balance and trunk coordination. Change from BaselineTrunk Impairment Scale at 6 weeks
Secondary Timed Up and Go Test It is used to evaluate dynamic balance and mobility skills. Change from Baseline Timed Up and Go Test at 6 weeks
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