Clinical trial NCT06821477: Impact of Knee Extension Brace on Quadriceps EMG During ASLR
Official title: Impact of Knee Extension Brace on Quadriceps Electromyography Activity During Active Straight Leg Rise
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: EMG
Exercise Response
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young healthy people 18-35 years old

Brief 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. 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:

1. Measurement of the MVC (maximum voluntary contraction) of the quadriceps of the thigh, in a sitting position with the lower leg flexed to 90 degrees.
2. Measurement of muscle activity during elevation of the straightened lower limb in a supine position without an orthosis.
3. 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 written consent to participate in the study, anthropometric measurements will be taken of height and weight 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 familiarised with the 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:

1. Measurement of the MVC (maximum voluntary contraction) of the quadriceps of the thigh, in a sitting position with the lower leg flexed to 90 degrees.
2. Measurement of muscle activity during elevation of the straightened lower limb in a supine position without an orthosis.
3. Measurement of muscle activity during straight leg raise in supine position with knee brace.

Ad.a. Measurement of quadriceps excitability of the dominant lower limb using surface EMG in a seated position with the trunk stabilised and the lower leg flexed to 90 degrees, stabilised in the distal part (without taking the foot) against a stationary object so as to execute maximal volitional isometric quadriceps muscle tension. Upper limbs crossed over the chest.

Ad.b. Measurement of right quadriceps excitability using surface EMG in supine position without orthosis. The subject raises the test limb by touching the anterior surface of the tibia to a pole set at 20 cm at the command 'raise leg', then lowers the limb at the command 'lower leg'. During the task there is a 1 second moment of holding the leg straight as the tibia touches the pole. This action is repeated three times.

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:

1. The test subject raises the test limb by touching the front surface of the tibia to a pole set at a height of 20 cm on the command 'raise leg', then lowers the limb on the command 'lower leg'. During the task there is a 1 second moment of holding the leg straight as the tibia touches the pole. This action is repeated three times.
2. The test subject is asked to apply maximum tension to the quadriceps (thigh muscle) (command 'press the knee against the ground, bring the toes together, straighten the foot and flex the quadriceps maximally"), then maintaining the tension he/she raises the limb touching the front surface of the tibia to the pole placed at the height of 20 cm on the command "raise the leg", then lowers the limb on the command "lower the leg". During the task there is a 1 second moment of holding the leg straight as the tibia touches the pole. This action is repeated three times.
3. Before the test, the test subject is verbally instructed to 'Try, despite the orthosis holding you upright, to bend the knee and raise the leg so that the quadriceps do not tense'. Then, on the command 'raise leg', the test subject raises the limb by touching the front surface of the tibia to a pole set at 20 cm, on the command 'lower leg' he lowers the limb. During the task there is a 1 second moment of keeping the leg straight as the tibia touches the pole. This activity is repeated three times.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: results in (mV) from EMG
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Jozef Pilsudski University of Physical Education
Study officials:
References: