The Effects of Core Stability Training in Chronic Stroke Patients

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Core stability training

Conventional therapy

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Core stability group

Conventional therapy group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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).

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.

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.

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.

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.

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.

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.

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05114044

First Posted

October 20, 2021

Last Updated

October 29, 2021

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05114044

Brief Title

The Effects of Core Stability Training in Chronic Stroke Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

June 19, 2019 (Actual)

Primary Completion Date

October 1, 2021 (Actual)

Study Completion Date

October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Core stability group

Arm Type

Experimental

Arm Description

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.

Arm Title

Conventional therapy group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Core stability training

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Conventional therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline score of Berg Balance Scale at week 3

Description

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.

Time Frame