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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03777111
Other study ID # 60116787-020/53283
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 11, 2018
Est. completion date January 13, 2021

Study information

Verified date January 2021
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Most of the daily life activities include dual task performance. Unlike conventional physiotherapy approaches, dual task training aims to improve both motor performance and cognitive performance at the same time. Geriatric rehabilitation approaches in Turkey; single task training (containing only motor performance) is applied to older adults for walking and balance disorders. Recent studies have shown gait parameters and balance abilities are influenced cognitive function and also dual task training is had to include in rehabilitation programs in order to improve walking and balance skills of the healthy elderly. In Turkey, a similar study is not found. The goal of this study is to evaluate in healthy elderly, effect of dual-task and single-task training on gait performance, and their effect on the balance abilities and functional mobility also to evaluate advantages one to another and to gain a different perspective to geriatric rehabilitation for the elderly in Turkey.


Description:

Protocol: In this study, the demographic information (age, gender, body mass index, education level, occupation, etc.) of all participants will be recorded first. In the first evaluation, the participants' gait parameters will be determined by using the 10-meter walking test and the wearable sensors. Balance is evaluated by Functional Reach Test, One Leg Stand Test and Tinetti Balance and Gait Assessment. Cognitive skills will be evaluated by using Mini Mental Test and Stroop Test. After the first evaluations of the participants, the participants will be given single or dual task training for 6 weeks, 2 times a week, not on consecutive days. If participants are absent for any training session, a compensation training session will be organized for them. After completing the single and / or dual task training, the final evaluations will be made. Randomization will be performed according to age, gender and body mass index of participants. After the randomization, participants' training group will be determined. Warm-up and cooling exercises will be carried out between 5-10 minutes before and after each training. Each training will consist of approximately 45-60 minutes including warm-up and cooling exercise periods. Each exercise starts with 5 repetitions and proceeds to 10 repetitions. To reduce the effects of fatigue and to draw attention, a break time that consists of approximately 1-2 minutes will be given. Statistical Analysis: The effect size obtained in the reference study was strong (d = 1.16). As a result of the power analysis using the effect size value in the reference study for the study, it was calculated that 80% power could be obtained at 95% confidence level when at least 20 people (10 people per group) were included the study. The data will be analyzed with Statistical Package for the Social Sciences (SPSS) package program. Continuous variables will be given as mean ± standard deviation and categorical variables as number and percentage. In the independent group comparisons, if the parametrical test assumptions are obtained, independent samples t-test will be used if the parametric test assumptions are not obtained Mann Whitney U test will be used. In the dependent group comparisons, when the parametric test assumptions are obtained, paired samples t-test; if not obtained Wilcoxon tests will be used.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 13, 2021
Est. primary completion date January 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 75 Years
Eligibility Inclusion Criteria: - At least to graduate from primary school or ability to read and write - Mini mental test score> 24 - Ability to achieve daily living activities independently - Ability to walk independently in the community (at least 10 meters without walking aids) Exclusion Criteria: - Presence of acute (fracture, surgery), chronic (Parkinson's diseases, diabetes or stroke) and cognitive (Alzheimer, dementia, etc.) diseases - Presence of hearing impairment that cannot be resolved by hearing devices and presence visual impairment that cannot be resolved by hearing aids.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Single Task Training: Single task training includes exercises that require only one task or stimulation. For this study the task consists of motor tasks (walking or balance) Dual Task Training: Dual task training includes exercises simultaneous performance of two tasks that can be performed independently, measured separately and with different goals. In the study motor tasks will combine with cognitive tasks.

Locations

Country Name City State
Turkey Pamukkale University Denizli Kinikli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Brustio PR, Rabaglietti E, Formica S, Liubicich ME. Dual-task training in older adults: The effect of additional motor tasks on mobility performance. Arch Gerontol Geriatr. 2018 Mar - Apr;75:119-124. doi: 10.1016/j.archger.2017.12.003. Epub 2017 Dec 10. — View Citation

Shin SS, An DH. The Effect of Motor Dual-task Balance Training on Balance and Gait of Elderly Women. J Phys Ther Sci. 2014 Mar;26(3):359-61. doi: 10.1589/jpts.26.359. Epub 2014 Mar 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 10 meter walk test This test will perform with wearable gait sensors and will evaluate gait parameters. six week
Primary Functional Reach Test Balance test six week
Primary One Leg stand Test Balance test six week
Primary Tinetti balance and gait assessment For evaluating balance and gait six week
Primary Stroop test cognitive test six week
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