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Clinical Trials/NCT05114044
NCT05114044
Completed
N/A

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

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital1 site in 1 country50 target enrollmentJune 19, 2019
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Enrollment
50
Locations
1
Primary Endpoint
Change from baseline score of 6 Minute Walk Test (6MWT) at week 3
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 19, 2019
End Date
October 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Sefa Gümrük Aslan

Consultant Physiatrist

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline score of 6 Minute Walk Test (6MWT) at week 3

Time Frame: Baseline and week 3 (after treatment)

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.

Change from baseline score of Trunk Impairment Scale (TIS) at week 3

Time Frame: Baseline and week 3 (after treatment)

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.

Change from baseline score of Timed Up and Go Test (TUG) at week 3

Time Frame: Baseline and week 3 (after treatment)

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.

Change from baseline score of Trunk Control Test at week 3

Time Frame: Baseline and week 3 (after treatment)

Trunk Control Test assess four simple aspect of trunk movement. Total score range: 0 to 100.

Change from baseline score of Functional Independence Measure (FIM) at week 3

Time Frame: Baseline and week 3 (after treatment)

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.

Change from baseline measurements Core muscle thickness at week 3

Time Frame: Baseline and week 3 (after treatment)

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).

Change from baseline score of Stroke Specific Quality of Life Scale (SS-QOL) at week 3

Time Frame: Baseline and week 3 (after treatment)

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.

Change from baseline score of Berg Balance Scale at week 3

Time Frame: Baseline and week 3 (after treatment)

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.

Change from baseline score of Motricity Index Scale for lower extremity at week 3

Time Frame: Baseline and week 3 (after treatment)

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).

Study Sites (1)

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