EMGNCT06821477
Impact of Knee Extension Brace on Quadriceps EMG During ASLR
An observational study of EMG and Exercise Response, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial summary
The main objective of this study is to evaluate quadriceps thigh muscle activity during active straight leg raise (ASLR) with a knee brace. An additional aim of the study is to evaluate quadriceps activity during straight leg raise with a knee brace in a variable command and manner of task performance. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- EMG, Exercise Response
- What is being tested?
- Superficial EMG
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 3 Feb 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: young healthy people 18-35 years old
Who may be able to join
- age between 18-35 years
- no contraindications to exercise
- ability to perform the required commands without pain or discomfort
- full range of motion of the knee joint.
Who cannot join
- those with a history of knee and/or hip surgery
- damage to ligamentous structures of the knee joint in the past treated conservatively or meniscus treated conservatively.
- muscle and tendon injury of the knee joint area in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Knee Extension Brace on Quadriceps Electromyography Activity During Active Straight Leg Rise
The main objective of this study is to evaluate quadriceps thigh muscle activity during active straight leg raise (ASLR) with a knee brace.
An additional aim of the study is to evaluate quadriceps activity during straight leg raise with a knee brace in a variable command and manner of task performance. The study will be conducted on a group of healthy individuals aged 18 - 35 years. Height and weight were measured using a scale and centimetre tape. Then, according to the study protocol, specific measurements will be taken of the rectus femoris, medial vastus and lateral vastus muscles using surface EMG of a non-invasive nature.
Read more
Study participants will undergo the following measurements:
- Measurement of the MVIC (maximum voluntary isometric contraction) of the quadriceps of the thigh, in a sitting position with the lower leg flexed to 90 degrees and in knee extended (0 degrees).
- Measurement of muscle activity during elevation of the straightened lower limb in a supine position without an orthosis.
- Measurement of muscle activity during straight leg raise in supine position with knee brace (default and different commends).
Read the detailed description
The study will be conducted on a group of healthy individuals aged 18 - 35 years. After an interview confirming that the subject does not have exclusion criteria and inclusion criteria apply. Written consent to participate in the study and next anthropometric measurements will be taken using a scale and tape measure. The subjects will be informed in detail about the procedure and the form of the measurements, the way in which they are to be taken, and will be familiarized with the measuring instruments and their principles of operation. Then, in accordance with the study protocol, specific measurements will be taken of the rectus femoris, medial vastus and lateral vastus muscles using surface EMG of a non-invasive nature.
Study participants will undergo the following measurements:
- Measurement of the MVIC (maximum voluntary isometric contraction) of the quadriceps femoris, in a sitting position with the lower leg flexed to 90 degrees, next MVIC of the quadriceps femoris in supine with knee fully extended (0 degrees).
- Measurement of muscle activity during elevation of the straightened lower limb (ASLR) in supine without knee brace.
- Measurement of muscle activity during ASLR in supine position with knee brace. Ad.a. Measurement of quadriceps maximum electric signal of the dominant lower limb using surface EMG in a seated position with the trunk stabilized with hands behind the pelvis and the lower leg flexed to 90 degrees, stabilized in the distal part (without taking the foot) against a stationary object (belt) to execute maximal volitional isometric quadriceps muscle contraction. Next MVIC in supine position, with knee fully extended, pushing back of the knee into hand of an examiner without lifting heel.
Ad.b. Measurement of quadriceps excitability using surface EMG in supine position without orthosis. The subject raises the tested limb (dominant) by touching the anterior surface of the tibia to a pole set at 30 cm at first sound of metronome set at 60 BMP, then hold the leg for the next beat, and next lowers the limb at the next metronome sound. This action is repeated three times in a row without any brake.
Ad.c. Measurement of quadriceps excitability of the dominant lower limb using surface EMG in supine position with knee extension brace on. Measurement performed in three variants:
- The subject raises the test limb (dominant) by touching the anterior surface of the tibia to a pole set at 30 cm at first sound of metronome set at 60 BMP, then hold the leg for the next beat, and next lowers the limb at the next metronome sound. This action is repeated three times in a row without any brake.
- The test subject is asked to apply maximum tension to the quadriceps then maintaining the tension he/she raises the limb touching the front surface of the tibia to the pole placed at the height of 30 cm at first sound of metronome set at 60 BMP, then hold the leg for the next beat, and next lowers the limb at the next metronome sound. This action is repeated three times.
- Before the test, the test subject is verbally instructed to 'Try, despite the orthosis holding your knee straight, to bend the knee and raise the leg so that the quadriceps do not tense'. Then, lift the limb touching the front surface of the tibia to the pole placed at the height of 30 cm at first sound of metronome set at 60 BMP, then hold the leg for the next beat, and next lowers the limb at the next metronome sound. This activity is repeated three times.
Between MVICs and test trial it was 30s brake. MVICs were hold for 3 seconds. The time for the full test is approximately 15-20 minutes per participant. Statistical analysis will be performed using Statistica and/or JASP software. The study will be carried out with a minimum of 20 adults aged 18 - 35 years. The exact number of participants in the study, will be determined after performing an a-priori sample size estimation after collecting data from the first 10 people examined. Eligibility of subjects will include a subject and physical examination by a physiotherapist.
Inclusion criteria: age between 18-35 years, no contraindications to physical exercise, ability to perform the required commands without pain or discomfort, full range of motion of the knee joint.
Exclusion criteria: those with a history of knee and/or hip surgery, damage to ligamentous structures of the knee joint in the past treated conservatively or meniscus treated conservatively, muscle and tendon injury of the knee joint area in the past 3 months.
- Conditions
- EMG, Exercise Response
- Being tested
- Superficial EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial EMGOther
Superfiscial EMG during ASLR without knee brace follow by EMG during ASLR with knee brace under certain commands
| Study group | Role | What they receive |
|---|---|---|
| 20 healthy young people | * age between 18-35 years
* no contraindications to exercise
* ability to perform the required commands without pain or discomfort
* full range of motion of the knee joint. Receives: Other: Superficial EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between RF from p1 (ASLR without orthosis) to RF from p2 (ASLR with orthosis, without any command)
It was decided to choose RF and generalize it to whole quadriceps femoris, thus decide what is the impact of the extension brace on EMG quadriceps signal
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Muscle (RF, VLO, VMO) comparison between trials and inside every trial
Percentage of mean value from MVIC in 90 (standard EMG normalization), will be compared between trial (ex. p1 RF vs p2 RF vs p3 RF vs p4 RF) and inside each trial (ex. p1 RF vs p1 VLO vs p1 VMO).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start3 Feb 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EMGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Kamiński, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821477
- Sponsor's protocol ID
- EMG_brace
- Status last verified
- Jul 2025
- First submitted
- 3 Feb 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD), including raw EMG data from electrodes and processed data normalized as %MVIC for statistical analysis, will be available upon reasonable request after primary results publication. Data will be anonymized to protect participant confidentiality and shared following ethical guidelines. Requests may be submitted to the corresponding author for up to 5 years post-publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Knee Extension Brace on Quadriceps Electromyography Activity During Active Straight Leg Rise
- ClinicalTrials.gov ID
- NCT06821477
- Acronym / sponsor ID
- EMG_brace
- Conditions
- EMG, Exercise Response
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate quadriceps thigh muscle activity during active straight leg raise (ASLR) with a knee brace.
An additional aim of the study is to evaluate quadriceps activity during straight leg raise with a knee brace in a variable command and manner of task performance. The study will be conducted on a group of healthy individuals aged 18 - 35 years. Height and weight were measured using a scale and centimetre tape. Then, according to the study protocol, specific measurements will be taken of the rectus femoris, medial vastus and lateral vastus muscles using surface EMG of a non-invasive nature.
Study participants will undergo the following measurements:
- Measurement of the MVIC (maximum voluntary isometric contraction) of the quadriceps of the thigh, in a sitting position with the lower leg flexed to 90 degrees and in knee extended (0 degrees).
- Measurement of muscle activity during elevation of the straightened lower limb in a supine position without an orthosis.
- Measurement of muscle activity during straight leg raise in supine position with knee brace (default and different commends).
Detailed description
The study will be conducted on a group of healthy individuals aged 18 - 35 years. After an interview confirming that the subject does not have exclusion criteria and inclusion criteria apply. Written consent to participate in the study and next anthropometric measurements will be taken using a scale and tape measure. The subjects will be informed in detail about the procedure and the form of the measurements, the way in which they are to be taken, and will be familiarized with the measuring instruments and their principles of operation. Then, in accordance with the study protocol, specific measurements will be taken of the rectus femoris, medial vastus and lateral vastus muscles using surface EMG of a non-invasive nature.
Study participants will undergo the following measurements:
- Measurement of the MVIC (maximum voluntary isometric contraction) of the quadriceps femoris, in a sitting position with the lower leg flexed to 90 degrees, next MVIC of the quadriceps femoris in supine with knee fully extended (0 degrees).
- Measurement of muscle activity during elevation of the straightened lower limb (ASLR) in supine without knee brace.
- Measurement of muscle activity during ASLR in supine position with knee brace. Ad.a. Measurement of quadriceps maximum electric signal of the dominant lower limb using surface EMG in a seated position with the trunk stabilized with hands behind the pelvis and the lower leg flexed to 90 degrees, stabilized in the distal part (without taking the foot) against a stationary object (belt) to execute maximal volitional isometric quadriceps muscle contraction. Next MVIC in supine position, with knee fully extended, pushing back of the knee into hand of an examiner without lifting heel.
Ad.b. Measurement of quadriceps excitability using surface EMG in supine position without orthosis. The subject raises the tested limb (dominant) by touching the anterior surface of the tibia to a pole set at 30 cm at first sound of metronome set at 60 BMP, then hold the leg for the next beat, and next lowers the limb at the next metronome sound. This action is repeated three times in a row without any brake.
Ad.c. Measurement of quadriceps excitability of the dominant lower limb using surface EMG in supine position with knee extension brace on. Measurement performed in three variants:
- The subject raises the test limb (dominant) by touching the anterior surface of the tibia to a pole set at 30 cm at first sound of metronome set at 60 BMP, then hold the leg for the next beat, and next lowers the limb at the next metronome sound. This action is repeated three times in a row without any brake.
- The test subject is asked to apply maximum tension to the quadriceps then maintaining the tension he/she raises the limb touching the front surface of the tibia to the pole placed at the height of 30 cm at first sound of metronome set at 60 BMP, then hold the leg for the next beat, and next lowers the limb at the next metronome sound. This action is repeated three times.
- Before the test, the test subject is verbally instructed to 'Try, despite the orthosis holding your knee straight, to bend the knee and raise the leg so that the quadriceps do not tense'. Then, lift the limb touching the front surface of the tibia to the pole placed at the height of 30 cm at first sound of metronome set at 60 BMP, then hold the leg for the next beat, and next lowers the limb at the next metronome sound. This activity is repeated three times.
Between MVICs and test trial it was 30s brake. MVICs were hold for 3 seconds. The time for the full test is approximately 15-20 minutes per participant. Statistical analysis will be performed using Statistica and/or JASP software. The study will be carried out with a minimum of 20 adults aged 18 - 35 years. The exact number of participants in the study, will be determined after performing an a-priori sample size estimation after collecting data from the first 10 people examined. Eligibility of subjects will include a subject and physical examination by a physiotherapist.
Inclusion criteria: age between 18-35 years, no contraindications to physical exercise, ability to perform the required commands without pain or discomfort, full range of motion of the knee joint.
Exclusion criteria: those with a history of knee and/or hip surgery, damage to ligamentous structures of the knee joint in the past treated conservatively or meniscus treated conservatively, muscle and tendon injury of the knee joint area in the past 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 healthy young people | – | Other: Superficial EMG* age between 18-35 years * no contraindications to exercise * ability to perform the required commands without pain or discomfort * full range of motion of the knee joint. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- young healthy people 18-35 years old
Key inclusion criteria (4 listed)
- age between 18-35 years
- no contraindications to exercise
- ability to perform the required commands without pain or discomfort
- full range of motion of the knee joint.
Key exclusion criteria (3 listed)
- those with a history of knee and/or hip surgery
- damage to ligamentous structures of the knee joint in the past treated conservatively or meniscus treated conservatively.
- muscle and tendon injury of the knee joint area in the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superficial EMGSuperfiscial EMG during ASLR without knee brace follow by EMG during ASLR with knee brace under certain commands | Other | 20 healthy young people |
Primary outcome
Comparison between RF from p1 (ASLR without orthosis) to RF from p2 (ASLR with orthosis, without any command)
Time frame: through study completion, an average of 1 year
It was decided to choose RF and generalize it to whole quadriceps femoris, thus decide what is the impact of the extension brace on EMG quadriceps signal
1 secondary outcome
Muscle (RF, VLO, VMO) comparison between trials and inside every trial
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD), including raw EMG data from electrodes and processed data normalized as %MVIC for statistical analysis, will be available upon reasonable request after primary results publication. Data will be anonymized to protect participant confidentiality and shared following ethical guidelines. Requests may be submitted to the corresponding author for up to 5 years post-publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EMG and Exercise Response, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between RF from p1 (ASLR without orthosis) to RF from p2 (ASLR with orthosis, without any command) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.