Aging DisorderNCT04151654
Effects of Footwear Suitability on Functional Performance and Balance in Elderly
A study testing Footwear Assessment Score in people with Aging Disorder and Aging Problems, run by Tuba Maden.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging Disorder, Aging Problems, Aging
- What is being tested?
- Footwear Assessment Score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2016to 27 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subject has not musculoskeletal injury within the last year.
- Subject has not needed gait assistance for ambulation.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging Disorder, Aging Problems, Aging
- Being tested
- Footwear Assessment Score
- Keywords
- aged, shoe, postural balance, accidental falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Footwear Assessment ScoreOther
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.
| Study group | Role | What they receive |
|---|---|---|
| assessment1 | Other | İt is assessment study. Assessment1 was evaluated for all test with and without footwear. Receives: Other: Footwear Assessment Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: through study completion, average one hour
Secondary outcomes (2)
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.
Measured: through study completion, average one hour
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.
Measured: through study completion, average one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start15 Apr 2016
- Primary completion20 Aug 2016
- Study completion27 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Aging DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuba Maden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuba Maden, Hasan Kalyoncu University
- Investigators
- KEZBAN BAYRAMLAR, Prof. Dr., Study director, Supervisor of Master Thesis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151654
- Sponsor's protocol ID
- 2016-06
- Status last verified
- Nov 2019
- First submitted
- 1 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
McPoil TG Jr. Footwear. Phys Ther. 1988 Dec;68(12):1857-65. doi: 10.1093/ptj/68.12.1857.
PubMed 3057521SIM-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.
PubMed 13587573Sahin 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.
PubMed 18489806Hatton 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.
PubMed 24297988Sherrington 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.
PubMed 12720618Menz 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.
PubMed 11843999Maden 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.
PubMed 33561615
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Footwear Suitability on Functional Performance Level and Balance in Elderly
- ClinicalTrials.gov ID
- NCT04151654
- Acronym / sponsor ID
- 2016-06
- Conditions
- Aging Disorder, Aging Problems, Aging
- Keywords
- aged, shoe, postural balance, accidental falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Tuba MadenUniversity, hospital or other
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 20 Aug 2016 (actual)
- Study completion
- 27 Sep 2016 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| assessment1 | Other | Other: Footwear Assessment Scoreİt is assessment study. Assessment1 was evaluated for all test with and without footwear. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Subject has not musculoskeletal injury within the last year.
- Subject has not needed gait assistance for ambulation.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Footwear Assessment ScoreIt 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. | Other | assessment1 |
Primary outcome
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).
2 secondary outcomes
Sharpened Romberg
Time frame: through study completion, average one hour
Single Leg Stance Test
Time frame: through study completion, average one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Results publication: PubMed 3057521McPoil TG Jr. Footwear. Phys Ther. 1988 Dec;68(12):1857-65. doi: 10.1093/ptj/68.12.1857.
- Results publication: PubMed 13587573SIM-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.
- Results publication: PubMed 18489806Sahin 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.
- Results publication: PubMed 24297988Hatton 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.
- Results publication: PubMed 12720618Sherrington 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.
- Results publication: PubMed 11843999Menz 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.
- Derived from this study: PubMed 33561615Maden 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.
- Monash University Physiotherapy DepartmentLink provided by the sponsor.
- Musculoskeletal Research CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KEZBAN BAYRAMLAR, Prof. Dr. study director
Supervisor of Master Thesis
Questions about this trial
What is this clinical trial studying?
A study testing Footwear Assessment Score in people with Aging Disorder and Aging Problems, run by Tuba Maden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Footwear Assessment Score (time frame: through study completion, average one hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04151654, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.