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COMPLETED
NCT07824336
NA

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

Sponsor: Taipei Veterans General Hospital, Taiwan

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2025-07-15

Completion Date

2025-11-21

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

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.

Locations (1)

Banqiao Veterans Home, VAC

New Taipei City, Taiwan