Effects of Footwear Suitability on Functional Performance and Balance in Elderly

Sponsor
Tuba Maden (Other)
Overall Status
Completed
CT.gov ID
NCT04151654
Collaborator
(none)
154
1
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Footwear Assessment Score
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
154 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The demographic information of the individuals (age, gender, height, body weight, body mass index (BMI), educational status) were recorded. 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. 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.The demographic information of the individuals (age, gender, height, body weight, body mass index (BMI), educational status) were recorded. 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. 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.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Investigating the Effects of Footwear Suitability on Functional Performance Level and Balance in Elderly
Actual Study Start Date :
Apr 15, 2016
Actual Primary Completion Date :
Aug 20, 2016
Actual Study Completion Date :
Sep 27, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Footwear Assessment Score [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.

  2. Berg Balance Scale [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.

  3. Functional Performance Evaluation [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 Outcome Measures

  1. Sharpened Romberg [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.

  2. Single Leg Stance Test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tuba Maden

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Tuba Maden, Principal Investigator, clinical research, Hasan Kalyoncu University
ClinicalTrials.gov Identifier:
NCT04151654
Other Study ID Numbers:
  • 2016-06
First Posted:
Nov 5, 2019
Last Update Posted:
Nov 8, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tuba Maden, Principal Investigator, clinical research, Hasan Kalyoncu University

Study Results

No Results Posted as of Nov 8, 2019