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

NCT07824336 | Completed

• 2 other identifiers: 2025-06-007C114VACS-004
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postural Balance; Gait; Functional Mobility

Keywords

custom-Made Total Contact Insoles; Older Adults; Postural Control; Timed Up and Go Test; Gait Analysis; Walking Speed; Plantar Pressure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Plantar Pressure During Walking

  Baseline, after initial use of the assigned insole condition, 4 weeks, and 8 weeks

Study Arms (2)

Custom-Made Total Contact Insole Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Custom-Made Total Contact Insole Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Banqiao Veterans Home, VAC

New Taipei City, 22058, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to group allocation. During insole replacement, footwear from participants in both groups was collected and handled using the same procedure. Participants were not informed whether their footwear had been fitted with the custom-made total contact insole or retained the control insole condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to either a custom-made total contact insole intervention group or a control group and were followed in parallel over an 8-week intervention period.

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: July 15, 2025
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)