- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07463924
The Gait Training in Different Directions in Elderly Individuals
The Effects of Gait Training in Different Directions on Balance, Fear of Falling, and Lower Extremity Performance in Elderly Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Denizli, Turkey (Türkiye)
- Pamukkale University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 65 years of age or older
- Volunteering to participate in the study
- Being able to speak and understand Turkish
Exclusion Criteria:
- Having any serious neurological, orthopedic, rheumatological, and cardiopulmonary diseases that could cause balance problems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Forward walking group
10 minutes of warm-up exercises, 15 minutes of strength and balance exercises, 18 minutes of forward walking, 5 minutes of cool-down exercises. The 18-minute forward walking exercise was performed in 3 sets of 6 minutes each, allowing for 3-minute rest breaks. The intervention was conducted 2 days a week for 8 weeks, totaling 16 sessions. |
In this intervention, in addition to the standard physiotherapy and rehabilitation program, an 18-minute forward walking exercise was performed.
Other Names:
In this intervention, in addition to the standard physiotherapy and rehabilitation program, an 18-minute backward walking exercise was performed.
Other Names:
In this intervention, in addition to the standard physiotherapy and rehabilitation program, an 18-minute sideways walking exercise was performed.
Other Names:
|
|
Experimental: Backward walking group
10 minutes of warm-up exercises, 15 minutes of strength and balance exercises, 18 minutes of backward walking, 5 minutes of cool-down exercises. The 18-minute backward walking exercise was performed in 3 sets of 6 minutes each, allowing for 3-minute rest breaks. The intervention was conducted 2 days a week for 8 weeks, totaling 16 sessions. |
In this intervention, in addition to the standard physiotherapy and rehabilitation program, an 18-minute forward walking exercise was performed.
Other Names:
In this intervention, in addition to the standard physiotherapy and rehabilitation program, an 18-minute backward walking exercise was performed.
Other Names:
In this intervention, in addition to the standard physiotherapy and rehabilitation program, an 18-minute sideways walking exercise was performed.
Other Names:
|
|
Experimental: Sideways walking group
10 minutes of warm-up exercises, 15 minutes of strength and balance exercises, 18 minutes of sideways walking, 5 minutes of cool-down exercises. The 18-minute sideways walking exercise was performed in 3 sets of 6 minutes each, allowing for 3-minute rest breaks. The intervention was conducted 2 days a week for 8 weeks, totaling 16 sessions. |
In this intervention, in addition to the standard physiotherapy and rehabilitation program, an 18-minute forward walking exercise was performed.
Other Names:
In this intervention, in addition to the standard physiotherapy and rehabilitation program, an 18-minute backward walking exercise was performed.
Other Names:
In this intervention, in addition to the standard physiotherapy and rehabilitation program, an 18-minute sideways walking exercise was performed.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Individuals' balance levels were assessed using the 4-Square Step Test.
Completion times were recorded in seconds.
|
From enrollment to the end of treatment at 8 weeks
|
|
Lower extremity performance
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Individuals' lower extremity performance was assessed using the Timed Up and Go Test.
|
From enrollment to the end of treatment at 8 weeks
|
|
Lower extremity performance
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Individuals' lower extremity performance was assessed using the Five Times Sit to Stand Test.
|
From enrollment to the end of treatment at 8 weeks
|
|
Fear of falling
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Individuals' levels of fear of falling were assessed using the Modified Fall Efficacy Scale.
The 14 items on the Modified Fall Efficacy Scale assess confidence when performing various daily tasks.
Items on the scale are scored from 0 (not confident) to 10 (completely confident) to evaluate participants' levels of self-efficacy regarding falls.
The total score is the average of the sum of all item scores.
Lower scores indicate a high level of fear of falling.
|
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Nilufer Cetisli-Korkmaz, Prof.Dr., Pamukkale University
Publications and helpful links
General Publications
- Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
- 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.
- Florence CS, Bergen G, Atherly A, Burns E, Stevens J, Drake C. Medical Costs of Fatal and Nonfatal Falls in Older Adults. J Am Geriatr Soc. 2018 Apr;66(4):693-698. doi: 10.1111/jgs.15304. Epub 2018 Mar 7.
- Hendricks HT, van Limbeek J, Geurts AC, Zwarts MJ. Motor recovery after stroke: a systematic review of the literature. Arch Phys Med Rehabil. 2002 Nov;83(11):1629-37. doi: 10.1053/apmr.2002.35473.
- Fritz NE, Worstell AM, Kloos AD, Siles AB, White SE, Kegelmeyer DA. Backward walking measures are sensitive to age-related changes in mobility and balance. Gait Posture. 2013 Apr;37(4):593-7. doi: 10.1016/j.gaitpost.2012.09.022. Epub 2012 Nov 2.
- Huang WY, Li MH, Lee CH, Tuan SH, Sun SF, Liou IH. Efficacy of lateral stair walking training in patients with chronic stroke: A pilot randomized controlled study. Gait Posture. 2021 Jul;88:10-15. doi: 10.1016/j.gaitpost.2021.04.026. Epub 2021 Apr 20.
- Toots A, Lundin-Olsson L, Nordstrom P, Gustafson Y, Rosendahl E. Exercise effects on backward walking speed in people with dementia: A randomized controlled trial. Gait Posture. 2021 Mar;85:65-70. doi: 10.1016/j.gaitpost.2020.12.028. Epub 2021 Jan 13.
- Baker NL, Cook MN, Arrighi HM, Bullock R. Hip fracture risk and subsequent mortality among Alzheimer's disease patients in the United Kingdom, 1988-2007. Age Ageing. 2011 Jan;40(1):49-54. doi: 10.1093/ageing/afq146. Epub 2010 Nov 18.
- Johansson H, Lundin-Olsson L, Littbrand H, Gustafson Y, Rosendahl E, Toots A. Cognitive function and walking velocity in people with dementia; a comparison of backward and forward walking. Gait Posture. 2017 Oct;58:481-486. doi: 10.1016/j.gaitpost.2017.09.009. Epub 2017 Sep 9.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-60116787-020-287513
- 1919B012301537 (Other Grant/Funding Number: Scientific and Technological Research Council of Türkiye (TUBITAK))
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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