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Clinical Trials/NCT04151654
NCT04151654
Completed
Not Applicable

Investigating the Effects of Footwear Suitability on Functional Performance Level and Balance in Elderly

Tuba Maden0 sites154 target enrollmentApril 15, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging Disorder
Sponsor
Tuba Maden
Enrollment
154
Primary Endpoint
Footwear Assessment Score
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Proper footwear serves to protect the foot against external factors. Balance and functional performance are affected by the level of footwear suitability. This study was designed to investigate the effects of footwear suitability on functional performance levels and balance in the elderly.

Detailed Description

The function of proper a footwear is to protect the foot against external factors. Balance and functional performance are affected by the level of footwear suitability. Particularly in elderly who have generally balance disorders and falling, footwear suitability is very important. Thus this study was designed to investigate the effects of footwear suitability on functional performance level and balance in elderly. The Footwear Assessment Score was used to assess parameters such as the design materials for footwear (upper and base), bending point, width, height of the toe box, getting out of the foot when walking, heel height, footwear style, wearing of the heel, and the distance between the longest toe and the end of the footwear. Thus, footwear was evaluated in many parameters. In the literature, there are studies in which footwear was evaluated in only parameter such as height of heel.

Registry
clinicaltrials.gov
Start Date
April 15, 2016
End Date
September 27, 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Tuba Maden
Responsible Party
Sponsor Investigator
Principal Investigator

Tuba Maden

Principal Investigator, clinical research

Hasan Kalyoncu University

Eligibility Criteria

Inclusion Criteria

  • Subject has not musculoskeletal injury within the last year.
  • Subject has not needed gait assistance for ambulation.

Exclusion Criteria

  • History of psychiatric, neurological and cognitive diseases.
  • history of visual and hearing problems.
  • Has poor coordination.
  • History of chronic diseases and acute pain.
  • has diabetic foot.

Outcomes

Primary Outcomes

Footwear Assessment Score

Time Frame: through study completion, average one hour

It was used to assess parameters such as the design materials for footwear (upper and base), bending point, width, height of the toe box, getting out of the foot when walking, heel height, footwear style, wearing of the heel, and the distance between the longest toe and the end of the footwear. A score of 30 on the scale represents the highest suitability level and the score taken from the scale indicates the suitability level of the footwear.

Berg Balance Scale

Time Frame: through study completion, average one hour

Test was used to evaluate participants' ability to maintain their balance when performing functional activities. A BERG score of 0 and 4 points for each variable assessed represents safe and independent execution of assigned tasks (normal performance), and unsafe and dependent execution of assigned tasks (unable to perform a task), respectively. This amounts to a total score of 56 points.The Turkish version of the scale was used and a cumulative score of 0-20 indicates high risk, 21-40 moderate risk and 41-56 low risk. The test was repeated twice; with and without footwear.

Functional Performance Evaluation

Time Frame: through study completion, average one hour

Timed Up and Go test (TUG) was used for evaluation of the functional performance. This test is important in terms of the assessment of mobility and balance. The participants were asked to stand from a sitting position, walk 3 m, turn back and sit back to the chair again. The test shows that it is an independent and reliable, as it involves most activities in everyday life. Duration of test was recorded. the performance duration was defined as normal balance (up to 12 s), good balance (up to 10 s) impaired balance (11-20 s) impaired balance-low risk of falling (11-20 s), and high risk of falling (longer than 20 s).

Secondary Outcomes

  • Sharpened Romberg(through study completion, average one hour)
  • Single Leg Stance Test(through study completion, average one hour)

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