The Effects of Core Stability Training in Chronic Stroke Patients

The Effects of Core Stability Training on Functional Ability and Muscle Thickness in Chronic Stroke Patients

The purpose of this study is to assess effects of core stability training on functional ability, balance, gait, motor functions, quality of lite and core muscle thickness of chronic stroke patients.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Core stability training; Other: Conventional therapy

Detailed Description

After being informed about the study all the patients giving written informed consent were assessed. At the beginning the eligible patients were randomized into two groups: core stability and conventional therapy group. The therapy programs were performed 5 times a week for 45 min over a period of 3 weeks. Patients were assessed twice: before and after treatment.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First onset
• Stroke duration from 6 months to 2 years
• With ability to cooperate
• Independent ambulation or ambulation with assistive device

Exclusion Criteria:

• Uncooperative
• Neglect syndrome
• Surgical history of abdominal and hip region
• Drugs that affect neuromuscular control
• Other neurological disorders
• Serious diseases, unstable medical condition
• BMI ≥ 35

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Core stability group; Patients were performed therapy 5 times a week for 45 min over a period of 3 weeks. The therapy session takes 45 min; 15 min of the session was core stability training, remaining 30 min were conventional therapy.	Other: Core stability training; The core stability training were performed 5 days a week for 15 min over a period of 3 weeks. The conventional therapy were performed 5 days a week for 30 min (remaining time of each session) over a period of 3 weeks. Duration of each session was 45 min.
Active Comparator: Conventional therapy group; Patients were performed therapy 5 times a week for 45 min over a period of 3 weeks. The therapy session takes 45 min of conventional therapy.	Other: Conventional therapy; The conventional therapy were performed 5 days a week for 45 min over a period of 3 weeks. Duration of each session was 45 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline score of Berg Balance Scale at week 3	Berg Balance Scale is reliable and valid tool to assess balance and functional mobility. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.	Baseline and week 3 (after treatment)
Change from baseline score of Motricity Index Scale for lower extremity at week 3	The Motricity Index was used to measure strength in upper and lower extremities after stroke. Assessing lower extremity strength is a 3 item list with each item consisting of a six point scale ranging from 0 to 33 (0, 9, 14, 19, 25, 33).	Baseline and week 3 (after treatment)
Change from baseline score of Trunk Control Test at week 3	Trunk Control Test assess four simple aspect of trunk movement. Total score range: 0 to 100.	Baseline and week 3 (after treatment)
Change from baseline score of 6 Minute Walk Test (6MWT) at week 3	6MWT is valid and reliable test to assess walking capacity of stroke patients. The distance that a patient can walk within six minutes is evaluated.	Baseline and week 3 (after treatment)
Change from baseline score of Functional Independence Measure (FIM) at week 3	FIM is valid and reliable scale to assess and grade the functional status of a person based on the level of assistance he or she requires. FIM is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.	Baseline and week 3 (after treatment)
Change from baseline score of Trunk Impairment Scale (TIS) at week 3	TIS is a tool to assess static and dynamic sitting balance and trunk coordination in a sitting position. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points.	Baseline and week 3 (after treatment)
Change from baseline score of Timed Up and Go Test (TUG) at week 3	TUG test is an assessment tool for measuring mobility in stroke patients. The TUG times a patient standing from a chair, walking 3 metres and returning to sit down.	Baseline and week 3 (after treatment)
Change from baseline score of Stroke Specific Quality of Life Scale (SS-QOL) at week 3	SS-QOL is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items. Items are rated on a 5-point Likert scale.	Baseline and week 3 (after treatment)
Change from baseline measurements Core muscle thickness at week 3	Thickness of five core muscles (rectus abdominis, external oblique, internal oblique, transversus abdominis, multifidus and gluteus medius) are measured by ultrasound. Paretic and nonparetic side of each patient are assessed twice (at baseline and after treatment).	Baseline and week 3 (after treatment)

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 23 (SIME)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No