Core Stabilization Exercises in Stroke

NCT05549518 | Completed

• 1 other identifier: 2015-KAEK-65-22-05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; core stabilization; respiratory parameters; balance

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Peak expiratory flow

  Change from Baseline Peak expiratory flow at 6 weeks

• Chest mobility

  Change from Baseline Chest mobility at 6 weeks

• Trunk Impairment Scale

  Change from BaselineTrunk Impairment Scale at 6 weeks

• Timed Up and Go Test

  Change from Baseline Timed Up and Go Test at 6 weeks

Study Arms (2)

Core stabilization + Traditional Physical Therapy

EXPERIMENTAL

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

Other: Core stabilization + Traditional Physical Therapy

Traditional Physical Therapy

ACTIVE COMPARATOR

This group will continue the traditional physical therapy program.

Other: Traditional Physical Therapy

Interventions

Core stabilization + Traditional Physical Therapy OTHER

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.

Core stabilization + Traditional Physical Therapy

Traditional Physical Therapy OTHER

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

Traditional Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• or less spasticity according to the Modified Ashworth Scale
• Stage 2 or higher according to the Functional Ambulation Classification

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, 3400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Buket AKINCI, Assoc. Prof.

  Biruni University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Interventional (Clinical Trial)

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 22, 2022
• Study Start: November 15, 2022
• Primary Completion: October 15, 2023
• Study Completion: October 30, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

TU (1)