Core Stabilization Exercises in Stroke

Sponsor

Biruni University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05549518

Collaborator

(none)

Enrollment

Location

Arms

2.4

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Core stabilization + Traditional Physical Therapy Other: Traditional Physical Therapy	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Interventional (Clinical Trial)Interventional (Clinical Trial)

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Core Stabilization Exercises on Respiratory Functions, Functional Capacity, Trunk Control and Balance in Individuals With Stroke

Anticipated Study Start Date :

Sep 20, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Core stabilization + Traditional Physical Therapy In addition to the traditional physical therapy training, core stabilization exercises will be applied in this group.	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.
Active Comparator: Traditional Physical Therapy This group will continue the traditional physical therapy program.	Other: 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

Arm

Intervention/Treatment

Experimental: Core stabilization + Traditional Physical Therapy

In addition to the traditional physical therapy training, core stabilization exercises will be applied in this group.

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.

Active Comparator: Traditional Physical Therapy

This group will continue the traditional physical therapy program.

Other: 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

Outcome Measures

Primary Outcome Measures

Tiffeneau ratio [Change from Baseline Tiffeneau ratio at 6 weeks]
Spirometric assessment will be performed to determine participants' Tiffeneau ratio (Forced Expiratory Volume 1. second (FEV₁)/ Forced Vital Capacity (FVC)).
2 Minutes Walking Test [Change from Baseline 2 Minutes Walking Test at 6 weeks]
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.

Secondary Outcome Measures

Peak expiratory flow [Change from Baseline Peak expiratory flow at 6 weeks]
Spirometric assessment will be performed to determine participants' peak expiratory flow
Chest mobility [Change from Baseline Chest mobility at 6 weeks]
It is measured from the axillary, epigastric, and subcostal regions during inhalation and exhalation to assess chest expansion and mobility.
Trunk Impairment Scale [Change from BaselineTrunk Impairment Scale at 6 weeks]
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.
Timed Up and Go Test [Change from Baseline Timed Up and Go Test at 6 weeks]
It is used to evaluate dynamic balance and mobility skills.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biruni University	Istanbul		Turkey	3400

Sponsors and Collaborators

Biruni University

Investigators

Study Chair: Buket AKINCI, Assoc. Prof., Biruni University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Buket AKINCI, Assoc. Prof., Biruni University

ClinicalTrials.gov Identifier:

NCT05549518

Other Study ID Numbers:

2015-KAEK-65-22-05

First Posted:

Sep 22, 2022

Last Update Posted:

Sep 22, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Buket AKINCI, Assoc. Prof., Biruni University

stroke

core stabilization

respiratory parameters

balance

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Sep 22, 2022