ElderlyNCT05319626
Immediate Effects of Two Different Lower Limb Sensory Stimulation Strategies on Balance and Mobility in Older Adults
A study testing compression socks, textured insoles and smooth socks in people with Elderly and Balance, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Falls are a major public health problem worldwide. As a result of changes in sensory system capacity with aging, postural control decreases and the risk of falling increases. Various lower-limb sensory stimulation strategies are applied to compensate for these changes in sensory system capacity. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- compression socks, textured insoles and smooth socks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2021to 20 Jun 2023
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community-dwelling older adults over the 65 years old with ability to stand independently without using any assistive devices
- No history of falls in the last 12 months
- Mini Mental State Examination (MMSE) score > 24 (normal)
- Berg Balance Test score > 40
Who cannot join
- Self-reported neurological, vestibular or neuromuscular diseases
- Current history of peripheral neuropathy
- Presence of severe visual impairment (such as cataracts or glaucoma)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Sciences
Çankaya, Ankara, 06490
About this study
Falls are a major public health problem worldwide. As a result of changes in sensory system capacity with aging, postural control decreases and the risk of falling increases. Various lower-limb sensory stimulation strategies are applied to compensate for these changes in sensory system capacity. It has been determined that these practices can have positive effects on postural control. Among these stimulation strategies, compression stockings and textured insoles are frequently preferred because of their cost-effectiveness and ease of application. For these purpose, this study aims to examine the immediate effects of wearing textured insoles and compression stockings on balance and mobility in older adults. Thus, we will sight to discern whether interventions of the textured insoles and compression materials improve sensory afferent feedback in the foot.
Read the detailed description
Within-subject experimental design with all participants tests under each of four randomly organized conditions: (i) Compression socks with textured insoles, (ii) Compression socks with smooth insoles, (iii) Smooth socks with textured insoles, (iv) Smooth socks with smooth insoles. With each condition, the participants are given a 5-minute warm-up period to get used to the insoles and stocking conditions, and then the testing process consisting of balance, mobility and foot sensation assessments is started. All data are collected randomly in a single testing session by the same researcher blind to the conditions.Before all data collection, each participant has a practice of test process to ensure familiarity with the devices and the procedures. A rest period of 10 minutes are given between applications.
- Being tested
- compression socks, textured insoles, smooth socks, smooth insoles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compression socksOther
The compression socks have a clinical pressure of 23-30 mm Hg. The socks are dressed to the participants based on the manufacturer's sizing guidelines.
textured insolesOther
The textured insoles have small, pyramidal peaks with centre-to-centre distances of approximately 2.5 mm (Evalite Pyramid EVA, 3 mm thickness, shore value A50, black). The insoles cut to a range of men's and women's standard EU shoe sizes. During the testing process, they are worn within a standardised shoe.
smooth socksOther
Also called control socks
The smooth socks are a commercial stocking that does not have a compression feature, but has a similar thickness and color to the compression stocking. They have standard size.
smooth insolesOther
Also called control insoles
The smooth insoles have a completely flat surface (Evalite Pyramid EVA, 3 mm thickness, shore value A50, black). The insoles cut to a range of men's and women's standard EU shoe sizes. During the testing process, they are worn within a standardised shoe.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Experimental | Compression socks with Textured insoles Receives: Other: compression socks; Other: textured insoles |
| Intervention group 2 | Experimental | Compression socks with Smooth insoles Receives: Other: compression socks; Other: smooth insoles |
| Intervention group 3 | Experimental | Smooth socks with Textured insoles Receives: Other: textured insoles; Other: smooth socks |
| Control group | Placebo comparator | Smooth socks with Smooth insoles Receives: Other: smooth socks; Other: smooth insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot sensation test
Foot plantar sense will be assessed with Semmes-Weinstein monofilament test. The foot sensation test will be performed (barefoot) immediately after each condition to determine the effect of the condition. 4 times in total.
Measured: in an average of one and half hour
Balance test
Balance will be assessed using the Biodex-BioSway™ Portable Balance System, in different visual situations and support surfaces during bilateral standing. It will be measured with each condition, 4 times in total.
Measured: in an average of one and half hour
Mobility test
Mobility will be assessed by selecting Time Up and Go and Walk parameters in the BTS G-Walk wearable motion analysis system. Time Up and Go test determines functional mobility, and fall risk. Walk test evaluates quantitative analysis for the performance of walking. It will be measured with each condition, 4 times in total.
Measured: in an average of one and half hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start18 Oct 2021
- Primary completion18 Apr 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Beyza Ölmez, Gazi University
- Investigators
- Sevim Beyza Ölmez, Principal investigator, Gazi UniversitySelda Başar, Study director, Gazi UniversityTuğçe Çoban, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319626
- Sponsor's protocol ID
- 2021-844
- Status last verified
- Jun 2023
- First submitted
- 28 Mar 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Woo MT, Davids K, Liukkonen J, Orth D, Chow JY, Jaakkola T. Effects of different lower-limb sensory stimulation strategies on postural regulation-A systematic review and meta-analysis. PLoS One. 2017 Mar 29;12(3):e0174522. doi: 10.1371/journal.pone.0174522. eCollection 2017.
PubMed 28355265Kenny RPW, Atkinson G, Eaves DL, Martin D, Burn N, Dixon J. The effects of textured materials on static balance in healthy young and older adults: A systematic review with meta-analysis. Gait Posture. 2019 Jun;71:79-86. doi: 10.1016/j.gaitpost.2019.04.017. Epub 2019 Apr 17.
PubMed 31022658Woo MT, Davids K, Chow JY, Jaakkola T. Acute effects of wearing compression knee-length socks on ankle joint position sense in community-dwelling older adults. PLoS One. 2021 Feb 8;16(2):e0245979. doi: 10.1371/journal.pone.0245979. eCollection 2021.
PubMed 33556067
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Two Different Lower Limb Sensory Stimulation Strategies on Balance and Mobility in Older Adults
- ClinicalTrials.gov ID
- NCT05319626
- Acronym / sponsor ID
- 2021-844
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 8 Apr 2022 (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.
Falls are a major public health problem worldwide. As a result of changes in sensory system capacity with aging, postural control decreases and the risk of falling increases. Various lower-limb sensory stimulation strategies are applied to compensate for these changes in sensory system capacity. It has been determined that these practices can have positive effects on postural control. Among these stimulation strategies, compression stockings and textured insoles are frequently preferred because of their cost-effectiveness and ease of application. For these purpose, this study aims to examine the immediate effects of wearing textured insoles and compression stockings on balance and mobility in older adults. Thus, we will sight to discern whether interventions of the textured insoles and compression materials improve sensory afferent feedback in the foot.
Detailed description
Within-subject experimental design with all participants tests under each of four randomly organized conditions: (i) Compression socks with textured insoles, (ii) Compression socks with smooth insoles, (iii) Smooth socks with textured insoles, (iv) Smooth socks with smooth insoles. With each condition, the participants are given a 5-minute warm-up period to get used to the insoles and stocking conditions, and then the testing process consisting of balance, mobility and foot sensation assessments is started. All data are collected randomly in a single testing session by the same researcher blind to the conditions.Before all data collection, each participant has a practice of test process to ensure familiarity with the devices and the procedures. A rest period of 10 minutes are given between applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Experimental | Other: compression socks, Other: textured insolesCompression socks with Textured insoles |
| Intervention group 2 | Experimental | Other: compression socks, Other: smooth insolesCompression socks with Smooth insoles |
| Intervention group 3 | Experimental | Other: textured insoles, Other: smooth socksSmooth socks with Textured insoles |
| Control group | Placebo comparator | Other: smooth socks, Other: smooth insolesSmooth socks with Smooth insoles |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Community-dwelling older adults over the 65 years old with ability to stand independently without using any assistive devices
- No history of falls in the last 12 months
- Mini Mental State Examination (MMSE) score > 24 (normal)
- Berg Balance Test score > 40
Key exclusion criteria (3 listed)
- Self-reported neurological, vestibular or neuromuscular diseases
- Current history of peripheral neuropathy
- Presence of severe visual impairment (such as cataracts or glaucoma)
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 |
|---|---|---|
| compression socksThe compression socks have a clinical pressure of 23-30 mm Hg. The socks are dressed to the participants based on the manufacturer's sizing guidelines. | Other | Intervention group 1, Intervention group 2 |
| textured insolesThe textured insoles have small, pyramidal peaks with centre-to-centre distances of approximately 2.5 mm (Evalite Pyramid EVA, 3 mm thickness, shore value A50, black). The insoles cut to a range of men's and women's standard EU shoe sizes. During the testing process, they are worn within a standardised shoe. | Other | Intervention group 1, Intervention group 3 |
| smooth socksAlso: control socksThe smooth socks are a commercial stocking that does not have a compression feature, but has a similar thickness and color to the compression stocking. They have standard size. | Other | Control group, Intervention group 3 |
| smooth insolesAlso: control insolesThe smooth insoles have a completely flat surface (Evalite Pyramid EVA, 3 mm thickness, shore value A50, black). The insoles cut to a range of men's and women's standard EU shoe sizes. During the testing process, they are worn within a standardised shoe. | Other | Control group, Intervention group 2 |
Primary outcome
Foot sensation test
Time frame: in an average of one and half hour
Foot plantar sense will be assessed with Semmes-Weinstein monofilament test. The foot sensation test will be performed (barefoot) immediately after each condition to determine the effect of the condition. 4 times in total.
Balance test
Time frame: in an average of one and half hour
Balance will be assessed using the Biodex-BioSway™ Portable Balance System, in different visual situations and support surfaces during bilateral standing. It will be measured with each condition, 4 times in total.
Mobility test
Time frame: in an average of one and half hour
Mobility will be assessed by selecting Time Up and Go and Walk parameters in the BTS G-Walk wearable motion analysis system. Time Up and Go test determines functional mobility, and fall risk. Walk test evaluates quantitative analysis for the performance of walking. It will be measured with each condition, 4 times in total.
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 22 Jun 2023.
- Background: PubMed 28355265Woo MT, Davids K, Liukkonen J, Orth D, Chow JY, Jaakkola T. Effects of different lower-limb sensory stimulation strategies on postural regulation-A systematic review and meta-analysis. PLoS One. 2017 Mar 29;12(3):e0174522. doi: 10.1371/journal.pone.0174522. eCollection 2017.
- Background: PubMed 31022658Kenny RPW, Atkinson G, Eaves DL, Martin D, Burn N, Dixon J. The effects of textured materials on static balance in healthy young and older adults: A systematic review with meta-analysis. Gait Posture. 2019 Jun;71:79-86. doi: 10.1016/j.gaitpost.2019.04.017. Epub 2019 Apr 17.
- Background: PubMed 33556067Woo MT, Davids K, Chow JY, Jaakkola T. Acute effects of wearing compression knee-length socks on ankle joint position sense in community-dwelling older adults. PLoS One. 2021 Feb 8;16(2):e0245979. doi: 10.1371/journal.pone.0245979. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Sevim Beyza Ölmez principal investigator
Gazi University
Selda Başar study director
Gazi University
Tuğçe Çoban principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compression socks, textured insoles and smooth socks in people with Elderly and Balance, run by Gazi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Foot sensation test (time frame: in an average of one and half 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 NCT05319626, which also lists 3 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 22 Jun 2023.