Effect of Total Contact Insoles Intervention on Balance Ability for the Elderly
11 de setembro de 2026 atualizado por: Taipei Veterans General Hospital, Taiwan
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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
49
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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New Taipei City, Taiwan, 22058
- Banqiao Veterans Home, VAC
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
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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.
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Sem intervenção: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Static Postural Control During Quiet Standing
Prazo: Baseline, immediately after initial insole use, Week 4, and Week 8
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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.
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Baseline, immediately after initial insole use, Week 4, and Week 8
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Timed Up and Go Total Time
Prazo: Baseline, immediately after initial insole use, Week 4, and Week 8
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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.
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Baseline, immediately after initial insole use, Week 4, and Week 8
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Gait Performance During the 10-Meter Walk Test
Prazo: Baseline, immediately after initial insole use, Week 4, and Week 8
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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.
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Baseline, immediately after initial insole use, Week 4, and Week 8
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Plantar Pressure During Walking
Prazo: Baseline, after initial use of the assigned insole condition, 4 weeks, and 8 weeks
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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.
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Baseline, after initial use of the assigned insole condition, 4 weeks, and 8 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de julho de 2025
Conclusão Primária (Real)
21 de novembro de 2025
Conclusão do estudo (Real)
21 de novembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
11 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de setembro de 2026
Primeira postagem (Real)
17 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2025-06-007C
- 114VACS-004 (Número de outro subsídio/financiamento: Veterans Affairs Council, R.O.C.)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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