- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07660926
Optimizing Hamstring Activation Through EMG-Feedback and the Hamshell Device (EMG-BF)
Обзор исследования
Статус
Вмешательство/лечение
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).
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jan Stutz, PhD
- Номер телефона: +41 61 465 64 88
- Электронная почта: research@rennbahnklinik.ch
Места учебы
-
-
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Muttenz, Швейцария, 4132
- Рекрутинг
- Rennbahnklinik
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Контакт:
- Jan Stutz, PhD
- Номер телефона: +41 61 465 64 88
- Электронная почта: research@rennbahnklinik.ch
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age between 18 and 40 years
- Recreationally active, defined as engaging in at least 150 minutes per week of moderate-intensity physical activity
Exclusion Criteria:
- Current or recent (≤6 months) musculoskeletal injury of the lower extremities
- Inability to follow study procedures or instructions
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: EMG-Biofeedback
Participants in this arm 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.
|
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.
|
|
Активный компаратор: Control
Particpants in the control group will perform the same training as the intervention group but without EMG feedback.
|
Particpants in the control group will perform the same training as the intervention group but without EMG feedback.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
iEMG biceps femoris during a modified Nordic Hamstring Exercise
Временное ограничение: Before and after the 5-week intervention period
|
Integrated EMG activity of the biceps femoris (BF) muscle during the modified version of the Nordic Hamstring Exercise.
|
Before and after the 5-week intervention period
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Hamstring and quadriceps strength
Временное ограничение: Before and after the 5-week intervention period
|
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
|
Before and after the 5-week intervention period
|
|
Hamstring flexibility
Временное ограничение: Before and after the 5-week intervention period
|
Hamstring flexibility assessed with the passive knee extension test
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Before and after the 5-week intervention period
|
|
EMG biceps femoris
Временное ограничение: Before and after the 5-week intervention period
|
EMG activity of the biceps femoris and gluteus maximus during the eccentric phase of the CMJ
|
Before and after the 5-week intervention period
|
|
Functional performance
Временное ограничение: Before and after the 5-week intervention period
|
Functional performance (CMJ vertical impulse)
|
Before and after the 5-week intervention period
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- EMG-BF
- 68158 (Идентификатор реестра: Swiss Human Research Portal)
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