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Идёт набор NCT07660926

Optimizing Hamstring Activation Through EMG-Feedback and the Hamshell Device

Без фазы С лечением Hamstring Muscles Hamstring Muscle Strength

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: EMG-Biofeedback-Training, Control.
Кому может быть актуально
Состояния в реестре: Hamstring Muscles, Hamstring Muscle Strength. Базовые параметры: 18 лет — 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

In this study, we investigate whether training of the posterior thigh muscles with visual feedback on muscle activity is more effective than the same training without feedback. To this end, healthy, physically active adults complete a training programme on a training device twice a week for five weeks. Muscle strength, muscle activity, and flexibility are measured before and after the training. Participants are randomly assigned to one of two groups: one group trains with feedback on muscle activity, the other without. Participation involves minimal risks, similar to those of a typical strength training session (e.g. muscle soreness). The aim of the study is to improve training methods for the prevention of muscle injuries.

Подробное описание

Hamstring injuries represent a significant burden in both recreational and competitive sports. Conventional hamstring training programmes primarily target muscle strength and hypertrophy. Despite generally positive outcomes, individual responses to strength-focused interventions vary considerably, suggesting that improvements in strength alone may not fully account for reductions in injury risk. Neuromuscular control and movement quality - factors likely relevant to hamstring injury risk - are not explicitly addressed in most traditional training protocols.

The Nordic hamstring exercise (NHE) is frequently used in clinical and sports practice, but presents biomechanical limitations, particularly with regard to loading at extended knee angles. The Hamshell device has been developed to address these limitations by enabling hamstring-specific loading across a broader range of knee angles.

Electromyographic (EMG) biofeedback is a technique in which real-time information about muscle electrical activity is provided to the user during exercise. This approach has been shown to enhance voluntary muscle activation and neuromuscular control in various rehabilitation and training contexts. Combining EMG biofeedback with Hamshell-based training may therefore optimise neuromuscular adaptations beyond what can be achieved with resistance training alone.

Study Design

This is a single-centre, prospective, randomised controlled intervention study with a parallel-group design, conducted at the Praxisklinik Rennbahn AG in Muttenz, Switzerland.

Participants

50 recreationally active adults (aged 18-40 years), defined as engaging in at least 150 minutes per week of moderate-intensity physical activity. Individuals with a current or recent (≤ 6 months) musculoskeletal injury of the lower extremities, or who are unable to follow study procedures, are excluded. Participants are randomly assigned in a 1:1 ratio to the intervention or control group (n = 25 per group).

Intervention

Both groups complete 10 training sessions over 5 weeks (twice per week), each lasting approximately 30 minutes, at the study centre. Sessions consist of hamstring and gluteus maximus exercises performed at extended knee angles using the Hamshell device. The first and middle sessions are supervised to ensure correct exercise technique and appropriate progression; EMG is recorded during these supervised sessions.

The intervention group receives real-time visual EMG biofeedback during all training sessions, aimed at optimising biceps femoris and gluteus maximus activation. The control group performs the identical training programme without any biofeedback.

Assessments

Participants undergo baseline (T0) and post-intervention (T1) assessments, each comprising:

* Hamstring flexibility testing * Countermovement jumps (CMJ) with simultaneous EMG recording of the biceps femoris and gluteus maximus * Three maximal voluntary contractions (MVCs) of the same muscles on the Hamshell device * Isokinetic strength testing of knee flexors and extensors in concentric and eccentric modes at 30°/s and 150°/s, and isometrically (0°/s), with concurrent EMG recording

Training adherence and session ratings of perceived exertion (RPE) are recorded for all sessions.

Primary Endpoint

Integrated EMG (iEMG) activity of the biceps femoris during the modified Nordic hamstring exercise, assessed at post-intervention (T1).

Secondary Endpoints

* Hamstring and quadriceps strength (isokinetic dynamometry, concentric and eccentric modes at 0°/s, 30°/s, and 150°/s) with concurrent EMG recording of the biceps femoris and gluteus maximus * Hamstring flexibility * EMG activity of the biceps femoris and gluteus maximus during the eccentric phase of the CMJ * Functional performance (CMJ vertical impulse) * Training adherence and session RPE

Statistical Analysis

Primary and secondary endpoints will be analysed using analysis of covariance (ANCOVA), with post-intervention values as the dependent variable, group allocation as the fixed factor, and corresponding baseline values as covariates.

Sample Size

A sample size of 25 participants per group (50 total) provides ≥ 80% power to detect a standardised mean difference of d = 0.81 (based on between-group iEMG differences reported by Croce et al.), at a two-sided significance level of α = 0.05.

Study Duration

The estimated duration of the main investigational period is approximately 12 months (First-Participant-In: June 2026; Last-Participant-Out: May 2027).

Вмешательства

  • Поведенческое EMG-Biofeedback-Training
    Participants complete 10 training sessions with EMG feedback over a 5-week period. The training is designed to optimize biceps femoris and gluteus maximus activation at extended knee angles using the Hamshell device. All training sessions last approximately 30 minutes and are conducted at the Rennbahnklinik. The first and middle training sessions are supervised to ensure correct exercise execution and appropriate progression. During these supervised session, EMG will be recorded.
  • Поведенческое Control
    Particpants in the control group will perform the same training as the intervention group but without EMG feedback.

Первичные конечные точки

  • iEMG biceps femoris during a modified Nordic Hamstring Exercise [Срок оценки: Before and after the 5-week intervention period]
Вторичные конечные точки (4)
  • Hamstring and quadriceps strength [Срок оценки: Before and after the 5-week intervention period]
  • Hamstring flexibility [Срок оценки: Before and after the 5-week intervention period]
  • EMG biceps femoris [Срок оценки: Before and after the 5-week intervention period]
  • Functional performance [Срок оценки: Before and after the 5-week intervention period]

Критерии участия

Критерии включения

  • Age between 18 and 40 years
  • Recreationally active, defined as engaging in at least 150 minutes per week of moderate-intensity physical activity

Критерии исключения

  • Current or recent (≤6 months) musculoskeletal injury of the lower extremities
  • Inability to follow study procedures or instructions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Швейцария · 1 центр
  • Rennbahnklinik — Muttenz

Идентификаторы

NCT: NCT07660926 · EMG-BF · 68158

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗