- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03777111
Effect of Single and Dual Task Training on Gait, Balance and Functional Mobility
Effect of Single and Double Task Training on Gait, Balance and Functional Mobility in the Elderly: Randomized Controlled Study
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Kınıklı
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Denizli, Kınıklı, Turkey, 20160
- Pamukkale University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Single Task Training Group
Gait and balance exercises will be applied in single task training group.
|
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.
|
Experimental: Dual Task Training Group
The exercises given in the single task training group will be combined with the cognitive tasks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10 meter walk test
Time Frame: six week
|
This test will perform with wearable gait sensors and will evaluate gait parameters.
|
six week
|
Functional Reach Test
Time Frame: six week
|
Balance test
|
six week
|
One Leg stand Test
Time Frame: six week
|
Balance test
|
six week
|
Tinetti balance and gait assessment
Time Frame: six week
|
For evaluating balance and gait
|
six week
|
Stroop test
Time Frame: six week
|
cognitive test
|
six week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Suat EREL, PhD
Publications and helpful links
General Publications
- 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.
- 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.
- Tasvuran Horata E, Cetin SY, Erel S. Effects of individual progressive single- and dual-task training on gait and cognition among older healthy adults: a randomized-controlled comparison study. Eur Geriatr Med. 2021 Apr;12(2):363-370. doi: 10.1007/s41999-020-00429-5. Epub 2020 Nov 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 60116787-020/53283
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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