- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07557797
Reeducação da Marcha para Corredores com Dor Patelofemoral
Intervenção de Reeducação da Marcha para Corredoras com Dor Patelofemoral: Ensaio Clínico Randomizado
Patellofemoral pain (PFP) is a common overuse injury in runners. Increased patellofemoral joint stress (PFJS) is an important biomechanical factor associated with PFP. Gait retraining, especially cadence modification, may reduce PFJS and improve symptoms, but evidence from randomized controlled trials remains limited. This study investigated whether wearable device-assisted gait retraining was more effective than education alone in reducing pain, improving function, and altering running biomechanics in female runners with PFP.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
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Beijing, China
- Beijing Sport University
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Female, Age 18-45 years
- Unilateral/bilateral anterior knee pain > 4 weeks
- VAS pain ≥ 3/10 during running and ≥ 2 of the following: jumping, squatting, kneeling, stairs, prolonged sitting, or resisted knee extension
- Running ≥ 15 km per week
- Natural rearfoot striker
Exclusion Criteria:
- Acute trauma, history of patellar dislocation, meniscal/chondral lesions
- Prior knee surgery or injection in past 12 months
- Rheumatologic, neurologic, or degenerative disease
- Pregnancy
Plano de estudo
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 |
|---|---|
|
Experimental: Gait retraining group
Participants received a 6-week gait retraining program plus patient education. |
The intervention is a wearable device-assisted gait retraining program (home) designed specifically for female runners with patellofemoral pain. PFP education, load management strategies, symptom-based training modifications, and strengthening exercises |
|
Comparador Ativo: Control group
Participants received a 6-week patient education program |
PFP education, load management strategies, symptom-based training modifications, and strengthening exercises |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Visual Analogue Scale for Pain during running
Prazo: Baseline, Week 6, Week 18
|
The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated during running. |
Baseline, Week 6, Week 18
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Visual Analogue Scale for usual pain
Prazo: Baseline, Week 6, Week 18
|
The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated for usual pain. |
Baseline, Week 6, Week 18
|
|
Anterior Knee Pain Scale
Prazo: Baseline, Week 6, Week 18
|
The Anterior Knee Pain Scale (AKPS), also referred to as the Kujala Score, is a patient-reported outcome measure designed to evaluate symptoms and functional limitations associated with anterior knee pain and patellofemoral disorders. It consists of 13 items covering domains such as pain during various activities (e.g., walking, running, jumping, climbing stairs, squatting), functional limitations, abnormal gait, muscle atrophy, and difficulty with prolonged sitting. Each item is scored on an ordinal scale, and the total score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms. |
Baseline, Week 6, Week 18
|
|
Knee Flexion Angle
Prazo: Baseline, Week 6
|
Peak knee flexion angle will be assessed during running trials using a 3-dimensional motion capture system. Reflective markers will be placed according to a standard lower-limb biomechanical model. |
Baseline, Week 6
|
|
Ground Reaction Force
Prazo: Baseline, Week 6
|
Ground reaction force (GRF) will be measured during overground running using embedded force plates synchronized with motion capture. |
Baseline, Week 6
|
|
Visual Analogue Scale for the worst pain
Prazo: Baseline, Week 6, Week 18
|
The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated for the worst pain. |
Baseline, Week 6, Week 18
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Step rates
Prazo: Baseline, Week 6
|
Step rates refer to the number of steps taken per unit of time, usually expressed as steps per minute (steps/min). |
Baseline, Week 6
|
|
Weekly running distance
Prazo: Baseline, Week 6
|
Weekly running distance refers to the total distance covered by a participant through running over one week, usually expressed in kilometers (km) or meters (m). This outcome is used to assess running volume. |
Baseline, Week 6
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Haonan Wang, Beijing Sport University
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
- 277S
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
What IPD will be shared:De-identified individual participant data that underlie the results reported in the publication, including baseline characteristics, outcome measures (pain scores, functional scores, running mechanics), and adverse events.
When will IPD be available:
Beginning 6 months after publication of the main trial results, for up to 5 years.
With whom:
Researchers who provide a methodologically sound proposal to achieve aims consistent with the original study.
For what types of analyses:
For individual participant data meta-analyses and reproducibility purposes.
How to access data:
Proposals should be directed to the corresponding author (wanghaonan@bsu.edu.cn). Data access will be provided via secure data transfer after approval of a data-sharing agreement.
Prazo de Compartilhamento de IPD
Beginning 6 months after publication of the main trial results, for up to 5 years.
Critérios de acesso de compartilhamento IPD
With whom: Researchers who provide a methodologically sound proposal to achieve aims consistent with the original study.
For what types of analyses:
For individual participant data meta-analyses and reproducibility purposes.
How to access data:
Proposals should be directed to the corresponding author (wanghaonan@bsu.edu.cn). Data access will be provided via secure data transfer after approval of a data-sharing agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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