Postural; DefectNCT06634537
Effect of Insoles on the Postural Control of Adults
A study testing Active Comparator: insoles hard, soft and barefoot in people with Postural; Defect and Adult, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
Background: there is a high risk of falls in older adults. One of the factors contributing to fall episodes is advancing age due to deterioration of the proprioceptive system. Certain clinical procedures improve balance and posture such as the use of insoles. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural; Defect, Adult, Orthopedic
- What is being tested?
- Active Comparator: insoles hard, soft and barefoot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 14 Oct 2024
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- The insoles involved are standard insoles which are not used to correct deformities; the differences between them concern the density of the materials (higher density is harder and lower density is softer). Participants could have any existing foot condition or deformity.
- Each pre-existing foot condition or deformity would be noted and listed for the sole purpose of evaluating the relationship between postural control and said deformity,
- have reached or are over 65 years of age,
- present with normal or corrected vision,
- capable of walking independently without the use of an assistive device, since the use of technical aids masks the potential effects of the insole.
Who cannot join
- present with a current injury, or injury 6 months prior to the test, in the lower limb,
- Suffer from a musculoskeletal disorder,
- present with uncorrected vision,
- are pregnant,
- experience neurological disorders, diabetes or lower limb amputation/prosthetics, plantar ulcers, or cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hard and Soft Density Insoles on the Postural Control of Adults Over 65 Years of Age
Background: there is a high risk of falls in older adults. One of the factors contributing to fall episodes is advancing age due to deterioration of the proprioceptive system. Certain clinical procedures improve balance and posture such as the use of insoles.
Objetive: to evaluate the impact of hard and soft insoles on static foot balance in healthy older adults compared to barefoot people.
Methods: a clinical trial was conducted with a sample size of 31 healthy with a mean age of 69.03±3.82 years. Postural control willevaluated in different conditions of barefoot balance with hard and soft insoles.
Read the detailed description
All subjects completed three testing sessions in a laboratory setting without external distraction. The same testing procedures were repeated during each session, with a time period of one week between sessions. All participants were asked for their information (age, sex, weight, height and date of birth), and they were then asked to take off their shoes in order to take the measurements. The Gyko® device was then placed in a harness on the back of the participant, who was subsequently asked to remain in an anthropometric position.
During the first testing session, postural impacts were assessed whilst subjects will barefoot. In the second testing session, subjects wore a soft gel insole: Cushioning gel slim (SIDAS, 18, rue Léon Béridot, Voiron, France: https://www.sidas.com/es/plantillas-para-el-uso-diario/156-cushioning-gel.html). During the third and final test, Winter+ insoles were used (SIDAS, 18, rue Léon Béridot, Voiron, France; https://www.sidas.com/es/plantillas-esqui-snowboard/221-winter-plus.html) .
Each session lasted around 30 seconds, data will collected while standing, with participants in in a bilateral stance. Each task was performed both with eyes open and eyes closed. To control for possible variations in visual field, subjects were asked to focus on a target placed 2 meters in front of them at eye level. If the person moved or lost balance, the data was discarded and the test was repeated until it was obtained correctly.
In each test, the data was managed as follows; the first 10 seconds of each test were discarded; the average of the remaining 20 seconds was taken for later analysis. Postural sway was assessed using a set of measures. The sway area (cm2) will calculated using the area of the ellipse generated by the software. Additionally, sway distance and sway velocity were assessed along the anterior-posterior and medial-lateral axes
- Conditions
- Postural; Defect, Adult, Orthopedic
- Being tested
- Active Comparator: insoles hard, soft and barefoot
- Keywords
- BALANCE, insoles, barefoot, olders adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: insoles hard, soft and barefootDevice
Also called Effet in postural control of hard and soft density insoles
Primary Outcome Measure:
- Stabilometry The measurements were conducted University. To assess participants' balance, the anthropometric position of the protocol proposed by the International Society for the Advancement of Cineatropometry (ISAK) was assigned: participants placed their mi Frankfort; the upper limbs remained relaxed throughout the body, with palms facing forward and thumbs separated from the rest of the toes, and were barefoot with feet externally rotated f 30 degrees and with a heel distance of 4cm.
The children were wearing sports costumes to contribute their free movement. For stabilometry data collection will use an inertial measurement instrument called Gyko® It is a state-of-the-art device that allows to measure an objective assessment of acceleration, angular velocity and with an acquisition frequency of 100Hz [Time Frame: pre intervention, 3 months post intervention, 6 months post intervention]
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Insoles soft and hard and barefoot | Experimental | Experimental: Active Comparator: Insoles soft The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Insoles hard and barefoot en 3 month and 6 month. Receives: Device: Active Comparator: insoles hard, soft and barefoot |
| Active Comparator: Insoles hard and soft and barefoot | Experimental | Experimental: Active Comparator: Insoles hard The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Insoles hard and barefoot en 3 month and 6 month. Receives: Device: Active Comparator: insoles hard, soft and barefoot |
| Active Comparator: barefoot and insoles hard and soft | Experimental | Experimental: Active Comparator: barefoot The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Insoles hard and barefoot en 3 month and 6 month. Receives: Device: Active Comparator: insoles hard, soft and barefoot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stabilometry
To evaluate balance, participants were instructed to maintain the protocol anthropometric position proposed by the International Society for the Advancement of Kinanthropometry (ISAK); participants positioned their head on the Frankfort plane, with their upper limbs in a relaxed position, palms facing forward, and thumbs separated from the rest of their fingers.
Participants were required to stand barefoot, with feet externally rotated at 30 degrees and a distance of 4 cm between both heels.
A Gyko inertial sensor system was used to collect the balance data (i.e. ellipse area (EA): length and surface area in cm2). The software automatically calculates the length and surface projection, the velocity projection and the frequency of oscillations. The Gyko system offers high reliability in measuring postural control compared to other measurement systems . Previous research has shown that this protocol had moderate to strong evidence of validity and reliability.
Measured: Pre intervention, 3 months post intervention, 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Mar 2024
- Primary completion1 Oct 2024
- Study completion14 Oct 2024
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 Postural; DefectStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicenta Martínez Córcoles, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634537
- Sponsor's protocol ID
- 23/604-E
- Status last verified
- Nov 2024
- First submitted
- 7 Oct 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hertel J, Sloss BR, Earl JE. Effect of foot orthotics on quadriceps and gluteus medius electromyographic activity during selected exercises. Arch Phys Med Rehabil. 2005 Jan;86(1):26-30. doi: 10.1016/j.apmr.2004.03.029.
PubMed 15640985Hatton AL, Dixon J, Martin D, Rome K. The effect of textured surfaces on postural stability and lower limb muscle activity. J Electromyogr Kinesiol. 2009 Oct;19(5):957-64. doi: 10.1016/j.jelekin.2008.04.012. Epub 2008 Jun 18.
PubMed 18565764Kulig K, Burnfield JM, Reischl S, Requejo SM, Blanco CE, Thordarson DB. Effect of foot orthoses on tibialis posterior activation in persons with pes planus. Med Sci Sports Exerc. 2005 Jan;37(1):24-9. doi: 10.1249/01.mss.0000150073.30017.46.
PubMed 15632663
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hard and Soft Density Insoles on the Postural Control of Adults Over 65 Years of Age
- ClinicalTrials.gov ID
- NCT06634537
- Acronym / sponsor ID
- 23/604-E
- Conditions
- Postural; Defect, Adult, Orthopedic
- Keywords
- BALANCE, insoles, barefoot, olders adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 10 Oct 2024 (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.
Background: there is a high risk of falls in older adults. One of the factors contributing to fall episodes is advancing age due to deterioration of the proprioceptive system. Certain clinical procedures improve balance and posture such as the use of insoles.
Objetive: to evaluate the impact of hard and soft insoles on static foot balance in healthy older adults compared to barefoot people.
Methods: a clinical trial was conducted with a sample size of 31 healthy with a mean age of 69.03±3.82 years. Postural control willevaluated in different conditions of barefoot balance with hard and soft insoles.
Detailed description
All subjects completed three testing sessions in a laboratory setting without external distraction. The same testing procedures were repeated during each session, with a time period of one week between sessions. All participants were asked for their information (age, sex, weight, height and date of birth), and they were then asked to take off their shoes in order to take the measurements. The Gyko® device was then placed in a harness on the back of the participant, who was subsequently asked to remain in an anthropometric position.
During the first testing session, postural impacts were assessed whilst subjects will barefoot. In the second testing session, subjects wore a soft gel insole: Cushioning gel slim (SIDAS, 18, rue Léon Béridot, Voiron, France: https://www.sidas.com/es/plantillas-para-el-uso-diario/156-cushioning-gel.html). During the third and final test, Winter+ insoles were used (SIDAS, 18, rue Léon Béridot, Voiron, France; https://www.sidas.com/es/plantillas-esqui-snowboard/221-winter-plus.html) .
Each session lasted around 30 seconds, data will collected while standing, with participants in in a bilateral stance. Each task was performed both with eyes open and eyes closed. To control for possible variations in visual field, subjects were asked to focus on a target placed 2 meters in front of them at eye level. If the person moved or lost balance, the data was discarded and the test was repeated until it was obtained correctly.
In each test, the data was managed as follows; the first 10 seconds of each test were discarded; the average of the remaining 20 seconds was taken for later analysis. Postural sway was assessed using a set of measures. The sway area (cm2) will calculated using the area of the ellipse generated by the software. Additionally, sway distance and sway velocity were assessed along the anterior-posterior and medial-lateral axes
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Longitudinal
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Insoles soft and hard and barefoot | Experimental | Device: Active Comparator: insoles hard, soft and barefootExperimental: Active Comparator: Insoles soft The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Insoles hard and barefoot en 3 month and 6 month. |
| Active Comparator: Insoles hard and soft and barefoot | Experimental | Device: Active Comparator: insoles hard, soft and barefootExperimental: Active Comparator: Insoles hard The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Insoles hard and barefoot en 3 month and 6 month. |
| Active Comparator: barefoot and insoles hard and soft | Experimental | Device: Active Comparator: insoles hard, soft and barefootExperimental: Active Comparator: barefoot The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Insoles hard and barefoot en 3 month and 6 month. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- The insoles involved are standard insoles which are not used to correct deformities; the differences between them concern the density of the materials (higher density is harder and lower density is softer). Participants could have any existing foot condition or deformity.
- Each pre-existing foot condition or deformity would be noted and listed for the sole purpose of evaluating the relationship between postural control and said deformity,
- have reached or are over 65 years of age,
- present with normal or corrected vision,
- capable of walking independently without the use of an assistive device, since the use of technical aids masks the potential effects of the insole.
Key exclusion criteria (5 listed)
- present with a current injury, or injury 6 months prior to the test, in the lower limb,
- Suffer from a musculoskeletal disorder,
- present with uncorrected vision,
- are pregnant,
- experience neurological disorders, diabetes or lower limb amputation/prosthetics, plantar ulcers, or cognitive impairment
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 |
|---|---|---|
| Active Comparator: insoles hard, soft and barefootAlso: Effet in postural control of hard and soft density insolesPrimary Outcome Measure: 1. Stabilometry The measurements were conducted University. To assess participants' balance, the anthropometric position of the protocol proposed by the International Society for the Advancement of Cineatropometry (ISAK) was assigned: participants placed their mi Frankfort; the upper limbs remained relaxed throughout the body, with palms facing forward and thumbs separated from the rest of the toes, and were barefoot with feet externally rotated f 30 degrees and with a heel distance of 4cm. The children were wearing sports costumes to contribute their free movement. For stabilometry data collection will use an inertial measurement instrument called Gyko® It is a state-of-the-art device that allows to measure an objective assessment of acceleration, angular velocity and with an acquisition frequency of 100Hz [Time Frame: pre intervention, 3 months post intervention, 6 months post intervention] | Device | Active Comparator: Insoles hard and soft and barefoot, Active Comparator: Insoles soft and hard and barefoot, Active Comparator: barefoot and insoles hard and soft |
Primary outcome
Stabilometry
Time frame: Pre intervention, 3 months post intervention, 6 months post intervention
To evaluate balance, participants were instructed to maintain the protocol anthropometric position proposed by the International Society for the Advancement of Kinanthropometry (ISAK); participants positioned their head on the Frankfort plane, with their upper limbs in a relaxed position, palms facing forward, and thumbs separated from the rest of their fingers. Participants were required to stand barefoot, with feet externally rotated at 30 degrees and a distance of 4 cm between both heels. A Gyko inertial sensor system was used to collect the balance data (i.e. ellipse area (EA): length and surface area in cm2). The software automatically calculates the length and surface projection, the velocity projection and the frequency of oscillations. The Gyko system offers high reliability in measuring postural control compared to other measurement systems . Previous research has shown that this protocol had moderate to strong evidence of validity and reliability.
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 2 Dec 2024.
- Background: PubMed 15640985Hertel J, Sloss BR, Earl JE. Effect of foot orthotics on quadriceps and gluteus medius electromyographic activity during selected exercises. Arch Phys Med Rehabil. 2005 Jan;86(1):26-30. doi: 10.1016/j.apmr.2004.03.029.
- Results publication: PubMed 18565764Hatton AL, Dixon J, Martin D, Rome K. The effect of textured surfaces on postural stability and lower limb muscle activity. J Electromyogr Kinesiol. 2009 Oct;19(5):957-64. doi: 10.1016/j.jelekin.2008.04.012. Epub 2008 Jun 18.
- Results publication: PubMed 15632663Kulig K, Burnfield JM, Reischl S, Requejo SM, Blanco CE, Thordarson DB. Effect of foot orthoses on tibialis posterior activation in persons with pes planus. Med Sci Sports Exerc. 2005 Jan;37(1):24-9. doi: 10.1249/01.mss.0000150073.30017.46.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: insoles hard, soft and barefoot in people with Postural; Defect and Adult, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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 5 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 2 Dec 2024. 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 Spain. 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. 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?
Stabilometry (time frame: Pre intervention, 3 months post intervention, 6 months post intervention). 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 NCT06634537, 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 2 Dec 2024.