- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07757932
Effects of a Wearable Postural Feedback Device on Scapular Muscle Endurance, Trunk Proprioception and Postural Awareness in Sedentary Office Workers
Effects of a Wearable Postural Feedback Device on Scapular Muscle Endurance, Trunk Proprioception and Postural Awareness in Sedentary Office Workers: Randomized Controlled Trial
This study aims to investigate the effects of a wearable postural feedback device on scapular muscle endurance, trunk proprioception, thoracic kyphosis angle, and postural awareness in sedentary office workers. A total of 70 sedentary office workers aged 25-45 years will be randomly allocated to either the wearable postural feedback device group or the control group using block randomization. Participants in the intervention group will use the wearable postural feedback device for 12 weeks (5 days per week, 60 minutes per day), while the control group will maintain their usual working routine without receiving any intervention. Outcome assessments will be performed at baseline, immediately after the 12-week intervention, and at the end of a 4-week follow-up period (Week 16).
The primary outcome measures are scapular muscle endurance, trunk proprioception, thoracic kyphosis angle, and postural awareness. The primary research question is whether the use of a wearable postural feedback device improves these outcomes in sedentary office workers compared with no intervention. It is hypothesized that participants using the wearable postural feedback device will demonstrate greater improvements in scapular muscle endurance, trunk proprioception, thoracic kyphosis angle, and postural awareness than those in the control group.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Sedentary behavior and prolonged office work have become increasingly common with the widespread use of computers and desk-based occupations. Prolonged sitting and sustained poor posture are associated with musculoskeletal disorders, particularly forward head posture, rounded shoulders, and increased thoracic kyphosis. These postural alterations may contribute to reduced scapular muscle endurance, impaired trunk proprioception, decreased postural awareness, and altered spinal alignment, ultimately affecting physical function and quality of life.
Wearable postural feedback devices have emerged as a promising strategy for promoting correct posture by providing real-time vibrotactile feedback whenever the user deviates from a predefined neutral posture. Previous studies have demonstrated that these devices may improve postural behavior and increase postural awareness. However, most published studies have been conducted in laboratory settings or have primarily focused on subjective outcomes and short-term postural changes. Evidence regarding their effects on objective neuromuscular outcomes, including scapular muscle endurance, trunk proprioception, and thoracic spinal alignment, in sedentary office workers remains limited.
This study is designed as a single-blind, randomized controlled trial to investigate the effects of a wearable postural feedback device on scapular muscle endurance, trunk proprioception, thoracic kyphosis angle, and postural awareness in sedentary office workers. 64 participants aged 25-45 years will be randomly assigned to either the intervention group or the control group using block randomization. Participants in the intervention group will use the wearable postural feedback device for 12 weeks (5 days per week, 60 minutes per day), while participants in the control group will continue their usual work routine without receiving any intervention.
Outcome measures will be assessed at baseline, immediately after the 12-week intervention, and following a 4-week follow-up period (Week 16). Scapular muscle endurance will be evaluated using the Scapular Muscle Endurance Test, trunk proprioception will be assessed using the Active Trunk Reposition Sense Test with the GYKO inertial sensor, thoracic kyphosis angle will be measured using the Commander® Echo Wireless Inclinometer device, and postural awareness will be assessed using the Postural Awareness Scale.
This study aims to provide high-quality evidence regarding the effectiveness of wearable postural feedback technology in improving neuromuscular function and spinal posture among sedentary office workers. The findings may contribute to the development of evidence-based workplace rehabilitation and ergonomic intervention strategies for the prevention and management of posture-related musculoskeletal disorders.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Ankara, Turquia (Türkiye)
- Faculty of Physiotherapy and Rehabilitation, University of Health Sciences Ankara
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Aged between 25 and 45 years. Sedentary lifestyle (<600 MET-min/week) determined using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Working in a desk-based occupation for at least 6 hours per day. Willing to use the wearable postural feedback device (intervention group). Able to provide written informed consent.
Exclusion Criteria:
History of scapular or spinal surgery or trauma. Presence of neurological or vestibular disorders. Spinal deformity. Dermatological conditions preventing the use of a wearable device. Chronic systemic diseases affecting posture or musculoskeletal function. Inability or unwillingness to provide written informed consent.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Wearable Postural Feedback Device Group
Device: Wearable Postural Feedback Device Participants will use a wearable postural feedback device for 12 weeks, 5 days per week, 60 minutes per day during working hours.
During the first week, device use will be gradually increased (20, 30, 40, 50, and 60 minutes/day) to improve adherence, followed by 60 minutes/day for the remaining 11 weeks.
The device provides real-time vibrotactile feedback when participants deviate from their calibrated neutral posture.
Outcome measures, including scapular muscle endurance, trunk proprioception, thoracic kyphosis angle, and postural awareness, will be assessed at baseline, immediately after the 12-week intervention, and at the end of the 4-week follow-up period (Week 16).
|
Participants assigned to the intervention group will use a wearable postural feedback device for 12 weeks, 5 days per week, 60 minutes per day during working hours.
During the first week, device use will be gradually increased (20, 30, 40, 50, and 60 minutes/day) to facilitate adaptation, followed by 60 minutes/day for the remaining 11 weeks.
The device is individually calibrated to each participant's neutral posture and provides real-time vibrotactile feedback whenever a deviation from the calibrated posture is detected, promoting immediate postural correction during daily work activities.
|
|
Sem intervenção: No Intervention: Control Group
Participants assigned to the control group will continue their usual work routine without receiving the wearable postural feedback device or any additional intervention.
Outcome measures, including scapular muscle endurance, trunk proprioception, thoracic kyphosis angle, and postural awareness, will be assessed at the same time points as the intervention group (baseline, Week 12, and Week 16).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Scapular Muscle Endurance
Prazo: Baseline, immediately after the 12-week intervention (Week 12), and at the end of the 4-week follow-up period (Week 16).
|
Scapular muscle endurance will be assessed using the Scapular Muscle Endurance (SME) Test.
Participants will stand with both shoulders and elbows positioned at 90° of flexion while maintaining the scapulae in a neutral position.
A handheld dynamometer will be used to apply a constant force of 1 kg (10 N).
Participants will maintain the test position as long as possible.
The test will be terminated if the force cannot be maintained, the upper extremity position changes, the supporting bar falls, or the participant reports pain.
Performance will be recorded in seconds, with longer durations indicating greater scapular muscle endurance.
|
Baseline, immediately after the 12-week intervention (Week 12), and at the end of the 4-week follow-up period (Week 16).
|
|
Trunk Proprioception
Prazo: Baseline, immediately after the 12-week intervention (Week 12), and at the end of the 4-week follow-up period (Week 16).
|
Trunk proprioception will be assessed using the Active Trunk Reposition Sense Test with the GYKO inertial sensor.
The sensor will be positioned at the thoracolumbar region according to the standardized protocol.
Participants, with their eyes closed, will actively reproduce a previously demonstrated trunk position.
The absolute repositioning error will be recorded in degrees (°).
Lower values indicate better trunk proprioception.
|
Baseline, immediately after the 12-week intervention (Week 12), and at the end of the 4-week follow-up period (Week 16).
|
|
Thoracic Kyphosis Angle
Prazo: Baseline, immediately after the 12-week intervention (Week 12), and at the end of the 4-week follow-up period (Week 16).
|
Thoracic kyphosis angle will be assessed using the Commander® Echo Wireless Inclinometer (JTECH Medical, USA).
Measurements will be performed according to a standardized thoracic spine assessment protocol.
Thoracic kyphosis angle will be recorded in degrees (°).
Lower values indicate a reduction in thoracic kyphosis and improved thoracic spinal alignment.
|
Baseline, immediately after the 12-week intervention (Week 12), and at the end of the 4-week follow-up period (Week 16).
|
|
Postural Awareness
Prazo: Baseline, immediately after the 12-week intervention (Week 12), and at the end of the 4-week follow-up period (Week 16).
|
Postural awareness will be assessed using the Postural Awareness Scale (PAS).
The PAS is an 11-item self-reported questionnaire with a total score ranging from 11 to 77.
Higher scores indicate greater postural awareness
|
Baseline, immediately after the 12-week intervention (Week 12), and at the end of the 4-week follow-up period (Week 16).
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-301
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .