Exploratory Study of Neuromuscular Profiles After Anterior Cruciate Ligament Reconstruction in Clinical Conditions: Combined Analysis of Isokinetic Strength and Surface Electromyography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Distribution of Neuromuscular Profiles
研究概览
简要总结
The NEURO-ACL-ISOEMG study is an observational, cross-sectional, exploratory study conducted in patients between 4 and 12 months after anterior cruciate ligament (ACL) reconstruction.
The primary objective is to describe the joint distribution of isokinetic muscle strength and surface electromyographic (sEMG) activation parameters of the quadriceps and hamstrings in order to explore different neuromuscular profiles under clinical conditions.
The study combines data from the routine functional assessment, including isokinetic strength measurements and a single-leg hop test, with surface electromyography and patient-reported questionnaires assessing knee self-efficacy, kinesiophobia, symptoms, and knee function.
详细描述
Persistent muscle strength deficits are frequently observed after anterior cruciate ligament (ACL) reconstruction and may be related to both peripheral muscular factors and alterations in neuromuscular activation. However, few studies have simultaneously assessed isokinetic strength and electromyographic activation of both agonist and antagonist muscles under analytical and functional conditions.
NEURO-ACL-ISOEMG is a monocentric, observational, cross-sectional, exploratory study designed to characterize neuromuscular profiles in patients evaluated between 4 and 12 months after ACL reconstruction.
The primary objective is to describe the joint distribution of isokinetic muscle strength and surface electromyographic activation parameters of the quadriceps and hamstrings. Isokinetic assessment includes quadriceps and hamstring peak torque and the Limb Symmetry Index (LSI). Surface electromyography is used to assess activation of the vastus medialis, vastus lateralis, semitendinosus, and biceps femoris during standardized isometric contractions.
Secondary objectives include describing electromyographic patterns during a single-leg functional task, exploring the concordance between electromyographic parameters obtained under analytical and functional conditions, describing the distribution of patients according to different combinations of isokinetic strength and electromyographic activation, and exploring associations between neuromuscular profiles, functional performance, and psychological factors. The study also assesses the completeness and usability of data obtained from the functional assessment in routine clinical practice.
Participants undergo a single study visit during their routine functional assessment after ACL reconstruction. Routine assessment includes isokinetic strength measurements and a single-leg hop test. For the purposes of the study, surface electromyography and three patient-reported questionnaires are added: the Knee Self-Efficacy Scale (K-SES), the Tampa Scale for Kinesiophobia (TSK), and the International Knee Documentation Committee (IKDC) questionnaire.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 横断面
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Anterior cruciate ligament (ACL) reconstruction.
- Postoperative period between 4 and 12 months.
- Age 18 years or older.
- Affiliation with or beneficiary of a social security scheme.
- Ability to understand the study information and to express non-opposition to participation.
排除标准
- Persons under guardianship, curatorship, or another legal protection measure.
- Any condition preventing safe performance of isokinetic testing, including significant pain, significant joint effusion, substantial limitation of joint range of motion, clinical knee instability, or an ongoing postoperative complication.
- Opposition to participation in the study.
研究组 & 干预措施
Patients After ACL Reconstruction
Adults evaluated between 4 and 12 months after anterior cruciate ligament (ACL) reconstruction as part of their routine functional assessment. Participants undergo isokinetic strength assessment and a single-leg hop test as part of routine care, complemented for the study by surface electromyography and patient-reported questionnaires assessing knee self-efficacy, kinesiophobia, symptoms, and knee function.
干预措施: Neuromuscular and Patient-Reported Assessmen (Other)
结局指标
主要结局
Distribution of Neuromuscular Profiles
时间窗: During the single study visit, between 4 and 12 months after ACL reconstruction
Participants will be classified into neuromuscular profiles based on the combined pattern of isokinetic strength and surface electromyographic activation of the quadriceps and hamstrings. The primary outcome will be the proportion of participants belonging to each identified neuromuscular profile, expressed as a percentage of the study population.
次要结局
- Surface Electromyographic Activity During the Single Leg Hop for Distance(During the single study visit, between 4 and 12 months after ACL reconstruction)
- Distribution of Participants Across Neuromuscular Profile(During the single study visit, between 4 and 12 months after ACL reconstruction)
- Correlation Between Neuromuscular Parameters and Functional and Patient-Reported Outcomes(During the single study visit, between 4 and 12 months after ACL reconstruction)
- Completeness of Neuromuscular and Functional Assessment Data(During the single study visit, between 4 and 12 months after ACL reconstruction)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT07792863
- 其他研究编号
- NEURO-ACL-ISOEMG, 2026-A01124-47
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (2个月后)
- 研究完成日期
- (3个月后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否