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Completed
NCT07824336
Effect of Total Contact Insoles Intervention on Balance Ability for the Elderly
Conditions: Postural Balance, Gait, Functional Mobility
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 49
Sponsor: Taipei Veterans General Hospital, Taiwan
Location: Banqiao Veterans Home, VAC New Taipei City
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.
Eligibility Criteria
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.
* History of lower-limb fracture or joint replacement affecting lower-limb length.
* Osteoporosis or vertebral compression fracture.
* Foot, ankle, or knee deformity, arthritis-related pain, or soft-tissue pain that interfered with study testing.
* Visual or hearing impairment affecting test safety or comprehension of instructions.
* History of psychiatric illness or substance misuse.
Source: ClinicalTrials.gov (NCT07824336). StuddyBuddy aggregates publicly available trial information.