- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07660926
Optimizing Hamstring Activation Through EMG-Feedback and the Hamshell Device (EMG-BF)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jan Stutz, PhD
- Phone Number: +41 61 465 64 88
- Email: research@rennbahnklinik.ch
Study Locations
-
-
-
Muttenz, Switzerland, 4132
- Recruiting
- Rennbahnklinik
-
Contact:
- Jan Stutz, PhD
- Phone Number: +41 61 465 64 88
- Email: research@rennbahnklinik.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
iEMG biceps femoris during a modified Nordic Hamstring Exercise
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hamstring and quadriceps strength
Time Frame: 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
Time Frame: Before and after the 5-week intervention period
|
Hamstring flexibility assessed with the passive knee extension test
|
Before and after the 5-week intervention period
|
|
EMG biceps femoris
Time Frame: 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
Time Frame: Before and after the 5-week intervention period
|
Functional performance (CMJ vertical impulse)
|
Before and after the 5-week intervention period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EMG-BF
- 68158 (Registry Identifier: Swiss Human Research Portal)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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