Effect of Total Contact Insoles Intervention on Balance Ability for the Elderly

September 11, 2026 updated by: Taipei Veterans General Hospital, Taiwan
This randomized controlled trial evaluated the effects of custom-made total contact insoles on postural control, functional mobility, walking performance, and plantar pressure characteristics in institutionalized older adults. Participants were randomly assigned to either an intervention group receiving custom-made total contact insoles or a control group continuing to use their usual insoles. The intervention period was 8 weeks, with assessments conducted at baseline, after initial use of the assigned insole condition, at 4 weeks, and at 8 weeks. Outcomes included static postural control, functional mobility assessed using the instrumented Timed Up and Go test, walking performance during a 10-meter walk test, and plantar pressure characteristics measured during walking. The study aimed to characterize changes in postural control, functional mobility, gait-related function, and plantar loading associated with custom-made total contact insole use over the intervention period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study was designed as a two-group randomized controlled trial involving institutionalized older adults residing in a veterans' residential care facility. Eligible participants were aged 65 years or older, were able to walk independently in daily life, had no previous experience using individually fabricated custom-made total contact insoles, were willing to use the assigned insole condition during daily activities, and were able to understand and comply with the study procedures. Participants were randomly assigned to either an intervention group or a control group. Participants in the intervention group received individually customized total contact insoles fabricated according to each participant's foot morphology and arch characteristics. Participants in the control group continued using their usual personal insoles. The assigned insole condition was maintained throughout the 8-week intervention period. Assessments were conducted at baseline, after initial use of the assigned insole condition, at 4 weeks, and at 8 weeks. Static postural control was assessed using force-platform measurements. Functional mobility and trunk movement characteristics were evaluated using an instrumented Timed Up and Go test. Walking performance was assessed during a 10-meter walk test using a wearable gait analysis system. During the 10-meter walk test, plantar pressure was simultaneously recorded using an in-shoe plantar pressure measurement system. Plantar pressure analysis included peak plantar pressure, timing of peak plantar pressure within the gait cycle, pressure-time integral, and contact area. Measurements were evaluated across plantar regions including the heel, midfoot, individual metatarsal regions, toe regions, and the total foot. Plantar pressure analyses were performed using data from the participant's dominant foot.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 22058
        • Banqiao Veterans Home, VAC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Aged 65 years or older. No previous use of individually fabricated custom-made total contact insoles. Able to walk independently in daily life. Willing to wear the assigned insoles during daily activities and complete follow-up assessments.

Able to follow simple instructions, understand the purpose of the study, and comply with the study procedures.

Exclusion Criteria:

Neurological disorders affecting gait or balance, such as Parkinson's disease, stroke, poliomyelitis, or lower-limb nerve injury.

Diabetes mellitus with peripheral neuropathy. Vertebral compression fracture. Arthritis-related or soft-tissue pain that interfered with study testing. Clinically evident visual or hearing impairment affecting test safety or comprehension of instructions.

History of psychiatric illness or substance misuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Custom-Made Total Contact Insole Group
Participants assigned to this group received individually customized total contact insoles and wore them during the 8-week intervention period. After the baseline assessment, participants wore the insoles and walked at least 320 steps for familiarization before the immediate post-intervention assessment. Participants were instructed to wear the insoles for at least per day during the intervention period.
Device: Custom-Made Total Contact Insoles
Individually customized total contact insoles were fabricated by trained orthotic professionals according to each participant's foot morphology. The insoles were designed to support the medial longitudinal arch, lateral longitudinal arch, and transverse arch, and to increase contact between the plantar surface of the foot and the insole. After the baseline assessment, participants wore the custom-made total contact insoles and walked at least 320 steps for familiarization before the immediate post-intervention assessment. Participants were instructed to wear the insoles for at per day during the 8-week intervention period.
No Intervention: Control Group
Participants assigned to the control group continued using their usual insoles and did not receive the custom-made total contact insole intervention during the 8-week study period. Footwear from participants in both groups was handled using the same procedure to maintain participant masking.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Static Postural Control During Quiet Standing
Time Frame: Baseline, immediately after initial insole use, Week 4, and Week 8
Static postural control was assessed using dual Hawkin Dynamics force platforms during three 30-second eyes-open quiet-standing trials. Outcomes included mediolateral and anteroposterior sway length, total sway length, sway range, and average sway velocity, calculated separately for the left and right sides to characterize postural stability and directional control during quiet standing.
Baseline, immediately after initial insole use, Week 4, and Week 8
Timed Up and Go Total Time
Time Frame: Baseline, immediately after initial insole use, Week 4, and Week 8
Functional mobility and movement control were assessed using the Timed Up and Go test with a G-Walk wearable inertial sensor. Outcomes included total completion time and phase durations for Sit-to-Stand, Forward Gait, Mid Turning, Return Gait, End Turning, and Stand-to-Sit. Maximum and minimum trunk accelerations in the vertical, mediolateral, and anteroposterior directions, peak trunk flexion and extension angles and ranges of motion during Sit-to-Stand and Stand-to-Sit, and mean and peak trunk angular velocities during turning phases were also recorded.
Baseline, immediately after initial insole use, Week 4, and Week 8
Gait Performance During the 10-Meter Walk Test
Time Frame: Baseline, immediately after initial insole use, Week 4, and Week 8
Gait performance was assessed during a 10-meter walk test using the G-Walk wearable inertial sensor positioned over the fifth lumbar vertebra. Participants walked at their natural or self-selected speed, and two trials were performed. Outcomes included cadence, gait speed, bilateral symmetry index, left and right stride cycle time, stride length, stride length normalized to height, stance phase, swing phase, first double-support phase, single-support phase, propulsion index, walking quality index, and pelvic tilt, obliquity, and rotation symmetry indices.
Baseline, immediately after initial insole use, Week 4, and Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plantar Pressure During Walking
Time Frame: Baseline, after initial use of the assigned insole condition, 4 weeks, and 8 weeks
Peak plantar pressure (kPa) was measured for the dominant foot using the F-Scan in-shoe plantar pressure system during the 10-meter walk test. Measurements were obtained for the total foot and predefined plantar regions, including the heel, midfoot, metatarsal regions, and toe regions.
Baseline, after initial use of the assigned insole condition, 4 weeks, and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-06-007C
  • 114VACS-004 (Other Grant/Funding Number: Veterans Affairs Council, R.O.C.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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