Skip to main content
OpenTrials
Completed

NCT Number: NCT07824336

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postural Balance Functional Mobility Gait

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banqiao Veterans Home, VAC

New Taipei City, 22058, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Custom-Made Total Contact Insoles

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.