Effects of Footwear Suitability on Functional Performance and Balance in Elderly

NCT04151654 | Completed

• 1 other identifier: 2016-06
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aging Disorder; Aging Problems; Aging

Keywords

aged; shoe; postural balance; accidental falls

Outcome Measures

Primary Outcomes (3)

• Footwear Assessment Score

  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

  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

  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 Outcomes (2)

• Sharpened Romberg

  through study completion, average one hour

• Single Leg Stance Test

  through study completion, average one hour

Study Arms (1)

assessment1

OTHER

İt is assessment study. Assessment1 was evaluated for all test with and without footwear.

Other: Footwear Assessment Score

Interventions

Footwear Assessment Score OTHER

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.

assessment1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tuba Maden: lead

Related Publications (7)

• McPoil TG Jr. Footwear. Phys Ther. 1988 Dec;68(12):1857-65. doi: 10.1093/ptj/68.12.1857.

  PMID: 3057521 RESULT

• SIM-FOOK L, HODGSON AR. A comparison of foot forms among the non-shoe and shoe-wearing Chinese population. J Bone Joint Surg Am. 1958 Oct;40-A(5):1058-62. No abstract available.

  PMID: 13587573 RESULT

• Sahin F, Yilmaz F, Ozmaden A, Kotevolu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Berg Balance Scale. J Geriatr Phys Ther. 2008;31(1):32-7. doi: 10.1519/00139143-200831010-00006.

  PMID: 18489806 RESULT

• Hatton AL, Rome K, Dixon J, Martin DJ, McKeon PO. Footwear interventions: a review of their sensorimotor and mechanical effects on balance performance and gait in older adults. J Am Podiatr Med Assoc. 2013 Nov-Dec;103(6):516-33. doi: 10.7547/1030516.

  PMID: 24297988 RESULT

• Sherrington C, Menz HB. An evaluation of footwear worn at the time of fall-related hip fracture. Age Ageing. 2003 May;32(3):310-4. doi: 10.1093/ageing/32.3.310.

  PMID: 12720618 RESULT

• Menz HB, Lord SR. The contribution of foot problems to mobility impairment and falls in community-dwelling older people. J Am Geriatr Soc. 2001 Dec;49(12):1651-6.

  PMID: 11843999 RESULT

• Maden T, Bayramlar K, Maden C, Yakut Y. Investigating the effects of appropriate fitting footwear on functional performance level, balance and fear of falling in older adults: A comparative-observational study. Geriatr Nurs. 2021 Mar-Apr;42(2):331-335. doi: 10.1016/j.gerinurse.2021.01.001. Epub 2021 Feb 6.

  PMID: 33561615 DERIVED

Related Links

• Monash University Physiotherapy Department
• Musculoskeletal Research Centre

Study Officials

• KEZBAN BAYRAMLAR, Prof. Dr.

  Supervisor of Master Thesis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, clinical research

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: April 15, 2016
• Primary Completion: August 20, 2016
• Study Completion: September 27, 2016
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share