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.

Study Overview

• Status: Completed
• Conditions: Gait; Postural Balance; Functional Mobility
• Intervention / Treatment: Device: Custom-Made Total Contact Insoles

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: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Static Postural Control During Quiet Standing	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	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	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

Outcome Measure	Measure Description	Time Frame
Plantar Pressure During Walking	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

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Actual): November 21, 2025
• Study Completion (Actual): November 21, 2025

Study Registration Dates

• First Submitted: September 11, 2026
• First Submitted That Met QC Criteria: September 11, 2026
• First Posted (Actual): September 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Older Adults; Gait Analysis; Plantar Pressure; Postural Control; Walking Speed; Timed Up and Go Test; custom-Made Total Contact Insoles
• Other Study ID 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