Effect of Insoles on the Postural Control of Adults

NCT06634537 | Completed

• 1 other identifier: 23/604-E
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postural; Defect; Adult; Orthopedic

Keywords

BALANCE; insoles; barefoot; olders adults

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre intervention, 3 months post intervention, 6 months post intervention

Study Arms (3)

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.

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.

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.

Device: Active Comparator: insoles hard, soft and barefoot

Interventions

Active Comparator: insoles hard, soft and barefoot DEVICE

Primary 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 \[Time Frame: pre intervention, 3 months post intervention, 6 months post intervention\]

Also known as: Effet in postural control of hard and soft density insoles

Active Comparator: Insoles hard and soft and barefoot; Active Comparator: Insoles soft and hard and barefoot; Active Comparator: barefoot and insoles hard and soft

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Universidad Miguel Hernández de Elche

Elche, Alicante, 03202, Spain

Location

Related Publications (3)

• 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.

  PMID: 15640985 BACKGROUND

• Hatton 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.

  PMID: 18565764 RESULT

• Kulig 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.

  PMID: 15632663 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator PhD

Model Details: Longitudinal

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 10, 2024
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 14, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)