Effects of Footwear Suitability on Functional Performance and Balance in Elderly

November 6, 2019 updated by: Tuba Maden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: assessment1
İt is assessment study. Assessment1 was evaluated for all test with and without footwear.
Other: Footwear Assessment Score
It was assessed using the Sharpened Romberg test and Single Leg Stance test for static balance. It was assessed Berg Balance Scale for dynamic balance, and Timed Up and Go test for functional performance. Balance and performance tests were done with and without footwear in all individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, average one hour
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.
through study completion, average one hour
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).
through study completion, average one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sharpened Romberg
Time Frame: through study completion, average one hour
Participants were asked to remain standing, on a straight line with one leg behind the other leg, leaving the arms sagging and without impairing the balance. Four measurements involving; right foot at behind with footwear, right foot at behind without footwear, left foot at behind with footwear, and left foot at behind without footwear were taken. Duration stop criteria were defined as the time it took a participant to dislocate the foot, reach the maximal duration of 30 sec, and contact the observer to avoid falling. h-Higher scores mean a better outcome.
through study completion, average one hour
Single Leg Stance Test
Time Frame: through study completion, average one hour
Duration of standing was measured in participants standing with dangling arms, with and without footwear. Maximal duration of test is 30 sec. Higher scores mean a better outcome.
through study completion, average one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuba Maden

Investigators

  • Study Director: KEZBAN BAYRAMLAR, Prof. Dr., Supervisor of Master Thesis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2016

Primary Completion (Actual)

August 20, 2016

Study Completion (Actual)

September 27, 2016

Study Registration Dates

First Submitted

November 1, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 8, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The demographic information of the individuals (age, gender, height, body weight, body mass index (BMI), educational status) were recorded. The wearing duration of footwear and accompanying disease was also recorded, and crossover methods were used for assessing balance and functional tests, with and without footwear. Footwear suitability was evaluated with the Footwear Assessment Score. Subjects were assessed using the Sharpened Romberg test and Single Leg Stance test for static balance, Berg Balance Scale for dynamic balance, and Timed Up and Go test for functional performance. Balance and performance tests were done with and without footwear in all individuals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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