Effects of Footwear Suitability on Functional Performance and Balance in Elderly

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151654
• Other study ID #: 2016-06
• Status: Completed
• Phase: N/A
• Start date: April 15, 2016
• Est. completion date: September 27, 2016

Study information

• Verified date: November 2019
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: September 27, 2016
• Est. primary completion date: August 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Aging Disorder
• Aging Problems

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tuba Maden

References & Publications (6)

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. Review. — View Citation

McPoil TG Jr. Footwear. Phys Ther. 1988 Dec;68(12):1857-65. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Sharpened Romberg	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
Secondary	Single Leg Stance Test	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

External Links

•   Monash University Physiotherapy Department
•   Musculoskeletal Research Centre