The Effects of Core Stability Training in Chronic Stroke Patients

NCT05114044 | Completed

• 1 other identifier: 23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (9)

• 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)

Study Arms (2)

Core stability group

EXPERIMENTAL

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

Conventional therapy group

ACTIVE COMPARATOR

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

Interventions

Core stability training OTHER

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.

Core stability group

Conventional therapy OTHER

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

Conventional therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physiatrist

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 9, 2021
• Study Start: June 19, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-10

Locations

TU (1)