Multiple Effects of Dual-Task Focused Training in Individuals with Chronic Stroke

February 28, 2025 updated by: Yasemin Şahbaz, University of Beykent
The aim of this study is to comprehensively investigate dual-task-focused training on balance, functionality, anxiety, healthy function and quality of life in chronic individuals. Stroke is a clinical condition that occurs as a result of deaths in the brain blood and is an important public health problem, ranking third among the causes of death in the world and first among the diseases that cause disability. There are a limited number of studies in the literature investigating the effectiveness of dual task training in stroke rehabilitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Unlike other studies in the literature, this designed study evaluates balance, functionality, anxiety, cognitive functions and quality of life in addition to walking, making it unique. In the light of all this information, the hypothesis of the study is as follows: Application of dual-task-oriented training in addition to the regular physiotherapy program in individuals with chronic stroke affects balance, functionality, anxiety levels, cognitive functions and quality of life. It is planned to include 40 participants who meet the inclusion criteria in the study. After giving the necessary verbal and written information about the study, participants who receive informed consent will be randomized and divided into 2 groups of 20 people each. Group 1 will receive 30 sessions of traditional neurological rehabilitation program every day for 6 weeks. In Group 2, in addition to traditional neurological rehabilitation, a dual-task-oriented training program will be applied for a total of 12 sessions, twice a week. Participants will be evaluated twice, before and after treatment. Researchers will record personal information through a socio-demographic data form. Balance will be evaluated with the Berg Balance Test, functional status will be evaluated with the 10 Meter Walk Test and Timed Up and Go Test, anxiety level will be evaluated with the Beck Anxiety Scale, cognitive functions will be evaluated with the Verbal Fluency Test, and Standardized Mini Mental Test and quality of life will be evaluated with the Stroke Specific Quality of Life Scale.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Beykent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Volunteering to work
  • Being between the ages of 40-70
  • Being diagnosed with stroke
  • Those who are not bedridden or wheelchair bound

Exclusion Criteria:

  • People with sensory impairments (those with severe hearing and vision loss)
  • Those with incompletely unioned fractures
  • People with infection
  • Those who have vestibular problems and balance problems
  • Those who cannot cooperate due to psychiatric or cognitive problems
  • Serious heart failure etc. those with systemic disease
  • Bilateral involvement
  • Accompanying serious orthopedic problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional Neurological Rehabilitation
In-bed lower and upper extremity passive-active assisted-active ROM exercises Lower and upper extremity strengthening exercises with Theraband Electrotherapy will be applied to increase muscle strength in the tibialis anterior, quadriceps femoris, forearm extensors and elbow extensors.
Other: Traditional Neurological Rehabilitation
Rehabilitation programs that start early after stroke and continue at regular intervals throughout life support the individual in regaining his quality of life and performing his daily functions. These programs can help patients increase their functional independence, improve their quality of life, and ensure their social integration. Physiotherapy and rehabilitation after stroke increases joint movement, provides independence in activities of daily living, improves balance and coordination, manages pain, supports speech and swallowing skills, provides psychological support, and promotes social integration.
Experimental: Traditional Neurological Rehabilitation + Dual Task Focused Training

In our Traditional Neurological Rehabilitation + Dual Task Focused Training group; Dual-task exercises were added in addition to the conventional treatment program.

For dual task training:

During in-bed exercises, the person will be asked to perform simple addition operations and rhythmic counting by 4 from 1 to 100.

During balance and walking exercises, the person will be asked to count rhythmically by 2 from 1 to 40.
Other: Traditional Neurological Rehabilitation + Dual Task Focused Training
Physiotherapy and rehabilitation after stroke increases joint movement, provides independence in activities of daily living, improves balance and coordination, manages pain, supports speech and swallowing skills, provides psychological support, and promotes social integration. Dual-task exercises, an important aspect of post-stroke rehabilitation, target both motor and cognitive functions. Dual tasks are activities that require performing two different tasks at the same time. These types of exercises are used to increase patients' attention, improve coordination, and help them perform daily living activities more effectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Test
Time Frame: 6 weeks
The balance of the patients will be evaluated twice with the Berg Balance Test, before and after the treatment. Each item of the Berg Denf-ge Test, which consists of 4 items, is scored between 0-4. In this test, which measures a person's performance in different positions, higher scores indicate better balance. 56 points indicate no risk of falling, 41-56 points indicate a slight risk of falling, 21-40 points indicate a moderate risk of falling, and below 20 points indicate a high risk of falling. A Turkish validity and reliability study of the scale was conducted.
6 weeks
10 Meter Walking Test
Time Frame: 6 weeks
The 10 meter walk test is a test generally used for physical capacity values. This test measures how long it takes an individual to travel a certain distance and can often be used in situations such as old age, detached parts, or certain health conditions. The application of the test is carried out by performing the following steps: Preparation of the test area, calculation of the starting position and walking speed.
6 weeks
Timed Up and Go Test Timed Up and Go Test Timed Up and Go Test
Time Frame: 6 weeks
A chair and a stopwatch are required to perform the test, which evaluates fall risk and mobility in the elderly. The test is performed with the shoes the patient always uses and is told that he can use walking aids if he needs it. The 3-meter area in front of the chair is determined. The patient is asked to get up from the chair, walk this distance and sit down again. The elapsed time gives the result of the test. What to say to the patient: When I say start, do the following steps one by one; 1. Get up from the chair 2. Walk at your normal pace to the line ahead 3. Turn back 4. Walk at your normal pace towards the chair 5. Sit down. If an elderly individual completes this test in more than 12 seconds, there is a risk of falling.
6 weeks
Beck Anxiety Scale
Time Frame: 6 weeks
Beck anxiety scale is a 4-point Likert type scale consisting of 21 questions that aims to measure the anxiety severity of the individual. Each question is scored between 0-3. A total score between 8 and 15 points from the scale indicates a low level of anxiety, a score between 16 and 25 indicates a moderate level of anxiety, and a score between 26 and 63 points indicates a high level of anxiety.
6 weeks
Verbal Fluency Test
Time Frame: 6 weeks
It is a test frequently used in the evaluation of neurological disorders. In this test, people produce meaningful words from specified letters or specified categories (such as animal names, proper names, fruit) for a certain period of time. During our evaluation, people will be asked to count all the proper nouns that come to their mind for 1 minute. The test will be completed by scoring the number of words produced during this period, taking into account the number of words they count outside the category and the number of words they repeat.
6 weeks
Standardized Mini Mental Test
Time Frame: 6 weeks
Standardized Mini Mental Test, a 30-item method, is a scale used to evaluate immediate memory, attention, recent memory and language functions. Due to its practicality and short-term applicability, it is widely used for screening purposes in samples thought to have cognitive impairment. The test has 5 subheadings. According to the scoring and evaluation method, orientation is grouped as 10 points, memory as 3 points, attention and calculation as 5 points, memory as 3 points, and language as 9 points. In general evaluation, 24-30 points indicate the normal value range, 18-23 points indicate a mild impact, and 0-17 points indicate a serious impact. As the total score increases, it indicates improvement.
6 weeks
Stroke-Specific Quality of Life Scale
Time Frame: 6 weeks
The Stroke-Specific Quality of Life Scale (SSQOL) is used to assess quality of life. SSQOL consists of 12 subsections including energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision and work-productivity, and a total of 49 questions. It is rated with a Likert type scoring from 1 to 5. The total score the patient can get is 49-245; As the score increases, it indicates improvement.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Beykent

Investigators

  • Principal Investigator: Yasemin ŞAHBAZ, Beykent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2024

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

August 10, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBeykent-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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