- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07922785
Stair Biomechanics and Vibration Study After ACLR
Lower Extremity Biomechanics During Gait and Stair Negotiation and Effects of Vibratory Stimuli Following ACL Reconstruction
This study examines how people who have had anterior cruciate ligament reconstruction (ACLR) move their legs during walking and stair negotiation, and whether a single session of vibration changes how they ascend and descend stairs.
Participants with ACLR (1 to 3 years after surgery) complete three laboratory visits. At the first visit, they complete walking, stair negotiation, muscle strength, hopping tests, and questionnaires, and stair negotiation is measured before and after a control condition without vibration. At the second and third visits, they receive whole-body vibration (standing on a vibrating platform) or local muscle vibration (a device placed over the thigh muscle) in a counterbalanced order, and stair negotiation is measured before and after each vibration session. Healthy participants matched by sex, age, and activity level complete one visit with the same tests as the first ACLR visit, for comparison.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Individuals with ACLR commonly show altered lower extremity biomechanics and quadriceps dysfunction that may contribute to the development of knee osteoarthritis. Stair negotiation places greater demands on the knee than level walking, yet findings on stair biomechanics after ACLR are inconsistent. Whole-body vibration (WBV) and local muscle vibration (LMV) acutely improve quadriceps function and gait biomechanics after ACLR, but their effects on stair biomechanics are unknown.
Aims: 1. to compare lower extremity biomechanics during gait, stair ascent, and stair descent between individuals 1 to 3 years after ACLR and matched healthy controls; 2. to determine inter-limb differences in biomechanics during gait and stair negotiation within individuals with ACLR; 3. to evaluate the acute effects of WBV and LMV on stair ascent and descent biomechanics in individuals with ACLR compared with a control condition.
Design: a case-control comparison nested within a single-blind, repeated-measures crossover design. ACLR participants complete three visits separated by at least 48 hours. Visit 1 is a baseline session with stair biomechanics assessed before and after a control condition (no vibration), plus gait biomechanics, isometric quadriceps and hamstring strength, single-leg and triple hop tests, and patient-reported outcomes. At visits 2 and 3, participants receive WBV and LMV in counterbalanced order, with stair biomechanics assessed immediately before and after the intervention. For all conditions, participants hold a squatted position (approximately 60 degrees of knee flexion) for 1 minute, repeated 6 times with 2 minutes of rest. WBV is delivered via a vibrating platform (30 Hz, 2 g). The control condition uses the same posture and timing without vibration. Healthy controls complete one visit identical to ACLR visit 1.
Biomechanics are collected with 3D motion capture synchronized with force plates under the second and third steps of an instrumented staircase. The data collector and outcome assessor are blinded to the vibration condition, which is administered by a separate research assistant.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Sansung Hwang, MS
- Número de telefone: 984-291-4830
- E-mail: sansungh@unc.edu
Estude backup de contato
- Nome: Troy Blackburn, PhD
- E-mail: troyb@unc.edu
Locais de estudo
-
-
North Carolina
-
Chapel Hill, North Carolina, Estados Unidos, 27599
- Motion Analysis Laboratory, University of North Carolina at Chapel Hill
-
Contato:
- Sansung Hwang, MS
- Número de telefone: 984-291-4830
- E-mail: sansungh@unc.edu
-
Contato:
- Troy Blackburn, PhD
- E-mail: troyb@unc.edu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria (all participants):
- Age 18 to 39 years
- Able to read, understand, and communicate in English sufficiently to provide informed consent and follow instructions
Inclusion Criteria (ACLR group):
- Primary, unilateral ACL reconstruction with patellar tendon autograft
- 1 to 3 years after ACL reconstruction
- Cleared by surgeon to return to unrestricted physical activity
- Returned to unrestricted walking, stair negotiation, and hopping activities
Exclusion Criteria (ACLR group):
- History of ACL injury to the opposite leg
- History of any knee surgery other than ACL reconstruction
- Diagnosis of osteoarthritis in any joint in either leg
- Major lower extremity injury (requiring surgery or more than 3 weeks of medical treatment) in the previous 6 months
- History of neurological disorder (e.g., stroke, cerebral palsy, multiple sclerosis)
- Currently pregnant
Inclusion Criteria (healthy controls):
- No history of ACL injury or knee surgery
- No history of major lower extremity injury (requiring surgery or more than 3 weeks of medical treatment)
- Matched to an ACLR participant by sex, age (within 3 years), and Tegner activity level (within 1 level)
Exclusion Criteria (healthy controls):
- Diagnosis of osteoarthritis in any joint in either leg
- Major lower extremity injury in the previous 6 months
- History of neurological disorder (e.g., stroke, cerebral palsy, multiple sclerosis)
- Currently pregnant
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: ACLR: WBV then LMV
Visit 1 control condition; Visit 2 whole-body vibration; Visit 3 local muscle vibration (at least 48 hours apart) |
Standing on a vibrating platform (Power Plate Pro 5) in a squatted position (approximately 60 degrees of knee flexion), 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.
Outros nomes:
A vibration device secured over the quadriceps muscle belly while standing in the same squatted position on the deactivated platform, 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.
Outros nomes:
Same squatted position and timing (1 minute x 6 exposures with 2 minutes of rest) without vibration. |
|
Experimental: ACLR: LMV then WBV
Visit 1 control condition; Visit 2 local muscle vibration; Visit 3 whole-body vibration (at least 48 hours apart) |
Standing on a vibrating platform (Power Plate Pro 5) in a squatted position (approximately 60 degrees of knee flexion), 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.
Outros nomes:
A vibration device secured over the quadriceps muscle belly while standing in the same squatted position on the deactivated platform, 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.
Outros nomes:
Same squatted position and timing (1 minute x 6 exposures with 2 minutes of rest) without vibration. |
|
Outro: Healthy controls
Single visit with the control condition; matched to ACLR participants by sex, age, (within 3 years), and Tegner activity level (within 1 level). |
Same squatted position and timing (1 minute x 6 exposures with 2 minutes of rest) without vibration. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Peak Hip Flexion Angle
Prazo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Maximum hip flexion angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Peak Knee Flexion Angle
Prazo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Maximum hip flexion angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Peak Ankle Flexion Angle
Prazo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Maximum ankle dorsiflexion angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Knee Valgus Angle
Prazo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Peak knee valgus (abduction) angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Knee Flexion Displacement
Prazo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Change in knee flexion angle from initial contact to peak knee flexion during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Sagittal Plane Knee Moment
Prazo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Peak internal knee extension moment during stance, normalized to body weight x height. Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Frontal Plane Knee Moment
Prazo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Peak internal knee abduction moment (equivalent to the external knee adduction moment) during stance, normalized to body weight x height. Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Peak Vertical Ground Reaction Force
Prazo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Peak vertical ground reaction force during stance, normalized to body weight (xBW). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Anterior Tibial Shear Force
Prazo: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Peak anterior tibial shear force during stance, normalized to body weight (xBW). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Isometric Quadriceps Peak Torque
Prazo: Visit 1 (baseline)
|
Maximal voluntary isometric knee extension torque measured on an isokinetic dynamometer (knee flexed 90 degrees, hip flexed 85 degrees); mean of 3 contractions per limb, normalized to body mass (Nm/kg). |
Visit 1 (baseline)
|
|
Isometric Hamstring Peak Torque
Prazo: Visit 1 (baseline)
|
Maximal voluntary isometric knee flexion torque measured on an isokinetic dynamometer (knee flexed 90 degrees, hip flexed 85 degrees); mean of 3 contractions per limb, normalized to body mass (Nm/kg). |
Visit 1 (baseline)
|
|
Quadriceps Rate of Torque Development
Prazo: Visit 1 (baseline)
|
Rate of torque development during maximal voluntary isometric knee extension contractions; mean of 3 contractions per limb, normalized to body mass (Nm/kg/s). |
Visit 1 (baseline)
|
|
Hamstring Rate of Torque Development
Prazo: Visit 1 (baseline)
|
Rate of torque development during maximal voluntary isometric knee flexion contractions; mean of 3 contractions per limb, normalized to body mass (Nm/kg/s). |
Visit 1 (baseline)
|
|
Single-Leg Hop for Distance
Prazo: Visit 1 (baseline)
|
Distance hopped on one leg, measured from the take-off line to the landing point of the heel; mean of 3 successful trials per limb (cm). |
Visit 1 (baseline)
|
|
Triple Hop for Distance
Prazo: Visit 1 (baseline)
|
Distance covered in three consecutive hops on one leg, measured from the take-off line to the landing point of the heel; mean of 3 successful trials per limb (cm). |
Visit 1 (baseline)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
International Knee Documentation Committee (IKDC) Subjective Knee Form
Prazo: Visit 1 (baseline)
|
Self-reported knee symptoms, function, and sports activity; score 0 to 100, higher scores indicate better knee function. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
Knee injury and Osteoarthritis Outcome Score (KOOS)
Prazo: Visit 1 (baseline)
|
Five subscales (Pain, Symptoms, Activities of Daily Living, Sport and Recreation, Knee-Related Quality of Life), each scored 0 to 100, higher scores indicate fewer problems. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
Tampa Scale of Kinesiophobia (TSK-11)
Prazo: Visit 1 (baseline)
|
Fear of movement and re-injury; score 11 to 44, higher scores indicate greater fear. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
Tegner Activity Scale
Prazo: Visit 1 (baseline)
|
Activity level; score 0 to 10, higher scores indicate higher activity levels. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
Marx Activity Rating Scale
Prazo: Visit 1 (baseline)
|
Frequency of running, cutting, decelerating, and pivoting; score 0 to 16, higher scores indicate more frequent activity. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
Anterior Cruciate Ligament Quality of Life (ACL-QOL) Questionnaire
Prazo: Visit 1 (baseline)
|
ACL-specific quality of life; score 0 to 100, higher scores indicate better quality of life. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
ACL Reasons Survey
Prazo: Visit 1 (baseline)
|
Self-reported return-to-activity status and reasons for limited physical activity after ACL injury. The survey has no total score. Responses will be reported descriptively as the number (%) of participants cleared to return to unrestricted activity, the number (%) in each activity category (as physically active as before injury; as active but participation is more challenging; less active than before injury), the number (%) selecting each of the 14 listed reasons, and the number (%) ranking each reason as most important. Reported for participants with ACLR. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sansung Hwang, MS, University of North Carolina, Chapel Hill
- Cadeira de estudo: Troy Blackburn, PhD, University of North Carolina, Chapel Hill
Publicações e links úteis
Publicações Gerais
- Pamukoff DN, Pietrosimone B, Ryan ED, Lee DR, Brown LE, Blackburn JT. Whole-Body Vibration Improves Early Rate of Torque Development in Individuals With Anterior Cruciate Ligament Reconstruction. J Strength Cond Res. 2017 Nov;31(11):2992-3000. doi: 10.1519/JSC.0000000000001740.
- Pamukoff DN, Pietrosimone B, Lewek MD, Ryan ED, Weinhold PS, Lee DR, Blackburn JT. Whole-Body and Local Muscle Vibration Immediately Improve Quadriceps Function in Individuals With Anterior Cruciate Ligament Reconstruction. Arch Phys Med Rehabil. 2016 Jul;97(7):1121-9. doi: 10.1016/j.apmr.2016.01.021. Epub 2016 Feb 8.
- Troy Blackburn J, Dewig DR, Johnston CD. Time course of the effects of vibration on quadriceps function in individuals with anterior cruciate ligament reconstruction. J Electromyogr Kinesiol. 2021 Feb;56:102508. doi: 10.1016/j.jelekin.2020.102508. Epub 2020 Nov 28.
- Blackburn T, Padua DA, Pietrosimone B, Schwartz TA, Spang JT, Goodwin JS, Dewig DR, Johnston CD. Vibration improves gait biomechanics linked to posttraumatic knee osteoarthritis following anterior cruciate ligament injury. J Orthop Res. 2021 May;39(5):1113-1122. doi: 10.1002/jor.24821. Epub 2020 Aug 12.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- 26-0478
- 26-SRC049 (Outro identificador: UNC-CH Scientific Review Committee)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data will not be shared outside the research team. Study results will be reported in aggregate in publications and presentations, and the informed consent does not include provisions for sharing individual-level data with other researchers or public repositories.
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 .