Clinical trial NCT06559930: Multiple Effects of Dual-Task Focused Training in Individuals with Chronic Stroke
Official title: Multiple Effects of Dual-Task Focused Training in Individuals with Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Dual Task
Physiotherapy
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: Patients will be divided into 2 groups of 20 people each. The random division of the cases into groups and their treatments will be done by the same researchers. The evaluation will be carried out by another researcher to determine which groups will be divided into before and after the treatment. After the initial evaluations are made, a traditional recording program of 30 sessions will be applied to Group 1, every day for 6 weeks. The 2nd group is traditionally equalized and a dual-task-focused training program is applied twice a week for a total of 12 sessions.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Berg Balance Test
timeFrame: 6 weeks
measure: 10 Meter Walking Test
timeFrame: 6 weeks
measure: Timed Up and Go Test Timed Up and Go Test Timed Up and Go Test
timeFrame: 6 weeks
measure: Beck Anxiety Scale
timeFrame: 6 weeks
measure: Verbal Fluency Test
timeFrame: 6 weeks
measure: Standardized Mini Mental Test
timeFrame: 6 weeks
measure: Stroke-Specific Quality of Life Scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beykent University
Study officials:
affiliation: Beykent University
name: Yasemin ŞAHBAZ
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bayot M, Dujardin K, Tard C, Defebvre L, Bonnet CT, Allart E, Delval A. The interaction between cognition and motor control: A theoretical framework for dual-task interference effects on posture, gait initiation, gait and turning. Neurophysiol Clin. 2018 Dec;48(6):361-375. doi: 10.1016/j.neucli.2018.10.003. Epub 2018 Oct 26.
citation: Plummer P, Iyigun G. Effects of Physical Exercise Interventions on Dual-Task Gait Speed Following Stroke: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Dec;99(12):2548-2560. doi: 10.1016/j.apmr.2018.04.009. Epub 2018 May 5.
citation: Meester D, Al-Yahya E, Dennis A, Collett J, Wade DT, Ovington M, Liu F, Meaney A, Cockburn J, Johansen-Berg H, Dawes H. A randomized controlled trial of a walking training with simultaneous cognitive demand (dual-task) in chronic stroke. Eur J Neurol. 2019 Mar;26(3):435-441. doi: 10.1111/ene.13833. Epub 2018 Nov 25.
citation: Lee YS, Bae SH, Lee SH, Kim KY. Neurofeedback training improves the dual-task performance ability in stroke patients. Tohoku J Exp Med. 2015 May;236(1):81-8. doi: 10.1620/tjem.236.81.
citation: Wong PL, Yang YR, Huang SF, Wang RY. Effects of Transcranial Direct Current Stimulation Followed by Treadmill Training on Dual-Task Walking and Cortical Activity in Chronic Stroke: A Double-Blinded Randomized Controlled Trial. J Rehabil Med. 2023 Mar 21;55:jrm00379. doi: 10.2340/jrm.v55.5258.
citation: Green J, Forster A, Young J. Reliability of gait speed measured by a timed walking test in patients one year after stroke. Clin Rehabil. 2002 May;16(3):306-14. doi: 10.1191/0269215502cr495oa.
citation: Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
citation: BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
citation: Hong SY, Moon Y, Choi JD. Effects of Cognitive Task Training on Dynamic Balance and Gait of Patients with Stroke: A Preliminary Randomized Controlled Study. Med Sci Monit Basic Res. 2020 Aug 10;26:e925264. doi: 10.12659/MSMBR.925264.