PostpartumNCT05073224
Muscle Function After Childbirth
A study testing Active Straight Leg Raise Test, Active Straight Leg Raise Fatigue Task and Lower Extremity Strength Testing in people with Postpartum and Muscle Fatigue, run by Carroll University at 1 site in United States.
Trial summary
This study will evaluate lower extremity and trunk neuromuscular control in 78 nulligravid and postpartum women. Participants will attend two experimental sessions, approximately 1 week apart, to assess neuromuscular function. Physical activity levels will also be assessed. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum, Muscle Fatigue, Force Steadiness
- What is being tested?
- Active Straight Leg Raise Test, Active Straight Leg Raise Fatigue Task and Lower Extremity Strength Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2022to Jul 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Post-partum
- Primiparous (this is their first child)
Who cannot join
- multiple gestation
- prescription anti-inflammatory/pain medications that are taken daily
- significant orthopedic conditions that would contraindicate performance of the fatigue task (such as fractures, severe scoliosis, etc)
- cardiovascular \& pulmonary disease
- neuromuscular health conditions (such as diabetes, neuropathy, multiple sclerosis, stroke, seizures, etc)
- history of previous abdominal surgery (with the exception of Cesarean delivery)
Show all 9Show fewer
- Nulligravid Women (Controls)
- Women from the surrounding community will also be recruited to serve as controls
- Nulligravid women will meet the same inclusion/exclusion criteria as the postpartum women, with the exception of never having been pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Biomechanics of the Lumbopelvic Stabilizing Muscles in Nulligravid and Postpartum Women
This study will evaluate lower extremity and trunk neuromuscular control in 78 nulligravid and postpartum women. Participants will attend two experimental sessions, approximately 1 week apart, to assess neuromuscular function. Physical activity levels will also be assessed.
Read the detailed description
Stability of the lumbar spine and pelvis is essential to nearly all activities of daily living, and is achieved primarily by muscular stabilization. Recent studies have shown that postpartum women are more fatigable than nulligravid women during fatiguing tasks with the lumbopelvic stabilizing muscles (23%) and the trunk flexor muscles (52%) at six months postpartum. Postpartum women also demonstrate impaired control of force with the trunk flexor muscles; however, it is unknown if force control during a fatiguing task of the lumbopelvic stabilizing muscles is impaired in postpartum women.
This study has 3 purposes: (1) To quantify limb steadiness during fatiguing exercise of the lumbopelvic stabilizing muscles among nulligravid women and postpartum women; (2) to quantify muscle activity in the trunk, test limb and contralateral limb to provide insight into motor control; and (3) to identify possible factors (inter-recti distance (IRD), physical activity, pain, biopsychosocial factors) that contribute to neuromuscular function (fatigability and force control).
This is a novel, translational study that, for the first time, will quantify lower extremity force control in postpartum women. As this has not been studied before, to the best of the investigators' knowledge, this proposal will be a pilot study to establish means to utilize in power analyses for future studies of larger magnitude. Furthermore, neuromuscular function is not typically assessed clinically in postpartum women, and no tests exist to easily assess fatigability of the lumbopelvic stabilizing muscles in clinic settings. This study will also provide further data to highlight the ASLR Fatigue Task as a possible clinical examination tool and outcome measure to assess fatigability of the lumbopelvic stabilizing muscles.
- Conditions
- Postpartum, Muscle Fatigue, Force Steadiness, Nulligravid, Muscle Weakness
- Being tested
- Active Straight Leg Raise Test, Active Straight Leg Raise Fatigue Task, Lower Extremity Strength Testing, Ultrasound imaging of abdominal wall
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Straight Leg Raise TestDiagnostic test
Also called ASLR Test
The ASLR test is a well-established clinical test that assesses stability of the lumbar spine/pelvis, posterior pelvic pain severity, and ability to activate the abdominal muscles. It is performed in supine. Participants are instructed to raise one leg, with the knee straight, to a heel height of 20 cm. The leg is held at the top for 5 seconds, then slowly lowered to the ground. The participant is asked to report perceived difficulty to raise the leg on a 0 to 5 scale (0=not at all difficult; 5=unable to lift leg) and pain on a 0 to 10 scale (0=no pain; 10=worst possible pain). If difficulty or pain are rated at a 1 or higher, the test is repeated with the researcher providing external compression of the pelvis. If perceived difficulty or reported pain are lower with compression, the test is considered positive for lumbopelvic instability. The test is then repeated on the opposite limb.
Active Straight Leg Raise Fatigue TaskOther
Also called ASLR Fatigue Task
The protocol is similar to the ASLR test, except that the participant is instructed to maintain the elevated leg off the ground for as long as possible. A biofeedback air cuff will be placed under the participant's lumbopelvic region to assess movement of the spine/pelvis. The cuff will be inflated to 40 mm Hg, and the participant instructed to keep the needle as close to 40 mm Hg as possible throughout the test; no information will be provided on how to affect cuff pressure, but visual feedback of cuff pressure will be provided throughout the task. Ratings of perceived exertion (RPE) and pain will be obtained from participants every 30-60 seconds. Task failure will be defined as a heel height ≤10 cm or a change in cuff pressure ≥20 mm Hg. Both limbs will be tested, but in different sessions. The order of limb testing (dominant vs non-dominant) will be randomized and counter-balanced. Limb dominance will be self-reported.
Lower Extremity Strength TestingOther
A straight leg raise maximal voluntary contraction (MVC) of each lower extremity an MVC of the hip extensors of the grounded limb will be performed in supine before and within 2 minutes of completing the ASLR fatigue task. The straight leg raise MVC will be performed with a custom-made load cell instrumented strength testing device, which consists of a rigid platform on which the participant will lie. At the foot of the device is a tower that houses 2 load cells connected to a lightly padded push plate.
The hip extension MVC will be performed on a force plate. Before the ASLR fatigue task, a minimum of 3 MVC trials will be performed for each muscle group, with a minimum of 1 minute rest between trials; the highest peak force will be considered the MVC. Only 1 MVC trial per muscle group will be performed following the ASLR Fatigue Task.
Ultrasound imaging of abdominal wallDiagnostic test
Real time ultrasound will be used to assess inter-recti distance above and below the umbilicus. Participants will be assessed with B Mode images in supine at rest, in supine while lifting their head, and in supine while performing a straight leg raise. The Principle Investigator has training and experience in musculoskeletal ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Postpartum | Experimental | Participants who are six months postpartum will complete 2 experimental sessions, separated by 7-10 days. Participants will complete multiple questionnaires, maximal voluntary contractions of the lower extremity muscles, clinical tests of lumbopelvic neuromuscular control/posterior pelvic pain provocation, and fatiguing lower extremity/trunk muscle exercise. Ultrasound imaging will be performed to measure inter-recti distance. Wireless Electromyography (EMG) sensors will be used to record EMG and limb steadiness (via Inertial Measurement Units (IMU). Physical activity will be measured by questionnaire and accelerometer. Receives: Diagnostic Test: Active Straight Leg Raise Test; Other: Active Straight Leg Raise Fatigue Task; Other: Lower Extremity Strength Testing; Diagnostic Test: Ultrasound imaging of abdominal wall |
| Nulligravid | Active comparator | Participants who have never been pregnant will complete 2 experimental sessions, separated by 7-10 days. Participants will complete multiple questionnaires, maximal voluntary contractions of the lower extremity muscles, clinical tests of lumbopelvic neuromuscular control/posterior pelvic pain provocation, and fatiguing lower extremity/trunk muscle exercise. Ultrasound imaging will be performed to measure inter-recti distance. Wireless EMG sensors will be used to record EMG and limb steadiness (via IMUs). Physical activity will be measured by questionnaire and accelerometer. Receives: Diagnostic Test: Active Straight Leg Raise Test; Other: Active Straight Leg Raise Fatigue Task; Other: Lower Extremity Strength Testing; Diagnostic Test: Ultrasound imaging of abdominal wall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Posterior Pelvic Pain
The Active Straight Leg Raise (ASLR) test is a well-established clinical test that assesses stability of the lumbar spine/pelvis, posterior pelvic pain severity, and ability to activate the abdominal muscles. It is performed in supine. Participants are instructed to raise one leg, with the knee straight, to a heel height of 20 cm. The leg is held at the top for 5 seconds, then slowly lowered to the ground. The participant is asked to report pain on a 0 to 10 scale (0=no pain; 10=worst possible pain). The test is then repeated on the opposite limb.
Measured: up to 10 days
Incidence of Perceived Difficulty with ASLR Task
The Active Straight Leg Raise (ASLR) test is a well-established clinical test that assesses stability of the lumbar spine/pelvis, posterior pelvic pain severity, and ability to activate the abdominal muscles. It is performed in supine. Participants are instructed to raise one leg, with the knee straight, to a heel height of 20 cm. The leg is held at the top for 5 seconds, then slowly lowered to the ground. The participant is asked to report perceived difficulty to raise the leg on a 0 to 5 scale (0=not at all difficult; 5=unable to lift leg). The test is then repeated on the opposite limb.
Measured: up to 10 days
Incidence of Lumbopelvic Instability
The Active Straight Leg Raise (ASLR) test is a well-established clinical test that assesses stability of the lumbar spine/pelvis, posterior pelvic pain severity, and ability to activate the abdominal muscles. It is performed in supine. Participants are instructed to raise one leg, with the knee straight, to a heel height of 20 cm. The leg is held at the top for 5 seconds, then slowly lowered to the ground. The participant is asked to report perceived difficulty to raise the leg on a 0 to 5 scale (0=not at all difficult; 5=unable to lift leg) and pain on a 0 to 10 scale (0=no pain; 10=worst possible pain). If difficulty or pain are rated at a 1 or higher, the test is repeated with the researcher providing external compression of the pelvis. If perceived difficulty or reported pain are lower with compression, the test is considered positive for lumbopelvic instability. The test is then repeated on the opposite limb.
Measured: up to 10 days
Mean Time to ASLR Fatigue Task Failure
For the ASLR Fatigue Task, the participant is instructed to maintain the elevated leg off the ground for as long as possible. Task failure will be defined as a heel height greater than or equal to 10 centimeters off the ground.
Measured: up to 10 days
Maximum Lower Extremity Strength: Leg
A straight leg raise maximal voluntary contraction (MVC) of each lower extremity will be performed in the supine position before and within 2 minutes of completing the ASLR fatigue task with a custom made load cell instrumented strength testing device. This device consists of a rigid platform on which the study participant will lie supine. At the foot of the device is a tower that houses 2 load cells and is connected to a lightly padded push plate. This push plate can be raised and lowered such that the participant can push up into the plate (contacts the anterior surface of the participant's shin) or push down onto the push plate (contacts the posterior aspect of the participant's heel).
Before the ASLR fatigue task, a minimum of 3 MVC trials will be performed on each leg, with a minimum of 1 minute rest between trials, in order to ensure a true maximum has been obtained; the highest peak force will be considered the MVC. Only 1 MVC trial per leg will be performed following the
Measured: up to 10 days
Maximum Lower Extremity Strength: Hip Extension
A hip extension MVC will also be performed in supine (pushing down into the ground) on a force plate (1000 Hz) prior to performance of the ASLR fatigue task. Only the leg that will remain in contact with the force plate during the ASLR fatigue task (grounded limb) will perform the extension MVC, in order to normalize downward pressure into the force plate by the grounded limb during performance of the ASLR fatigue task. This will allow us to quantify activity of the grounded limb during the fatiguing task. A minimum of 3 hip extension MVCs will be performed, with 1 minute rest between trials. An MVC may also be assessed at the end of the fatiguing exercise bout.
Measured: up to 10 days
Limb Steadiness Measured by Limb Acceleration
An inertial measurement unit (Trigno, Delsys, Boston, MA) will be placed on the test limb to track movement of the limb during performance of the ASLR Fatigue Task. Fluctuations in limb acceleration will be measured and quantified as the standard deviation of acceleration. Limb steadiness will be collected online, stored, and analyzed offline with ConsensysPRO software. The investigators hypothesize that fluctuations in limb acceleration will be greater among postpartum women as compared to nulligravid women during the performance of the ASLR Fatigue Task.
Measured: up to 10 days
Abdominal Fascial Integrity Measured by Mean Inter-Recti Distance
Real time ultrasound will be used to assess inter-recti distance above and below the umbilicus. Participants will be assessed with B Mode images in supine at rest, in supine while lifting their head, and in supine while performing a straight leg raise.
Measured: up to 10 days
Secondary outcomes (18)
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Ratings of Perceived Exertion (RPE)
For the ASLR Fatigue Task, the participant is instructed to maintain the elevated leg off the ground for as long as possible. A biofeedback air cuff placed under the participant's lumbopelvic region assesses movement of the spine/pelvis during the test. The cuff will be inflated to 40 mm Hg, and the participant will be instructed to keep the needle as close to 40 mm Hg as possible throughout the test. Ratings of perceived exertion (RPE, from 0-10 with higher scores increased exertion) are measured every 30-60 seconds. Task failure will be defined as a heel height ≤10 cm or a change in cuff pressure ≥20 mm Hg. Both limbs will be tested in different sessions.
Measured: up to 10 days
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
For the ASLR Fatigue Task, the participant is instructed to maintain the elevated leg off the ground for as long as possible. A biofeedback air cuff placed under the participant's lumbopelvic region assesses movement of the spine/pelvis during the test. The cuff will be inflated to 40 mm Hg, and the participant will be instructed to keep the needle as close to 40 mm Hg as possible throughout the test. Pain Scores will be measured (0-10 with higher scores increased pan) every 30-60 seconds. Task failure will be defined as a heel height ≤10 cm or a change in cuff pressure ≥20 mm Hg. Both limbs will be tested in different sessions.
Measured: up to 10 days
Average Total Activity Counts (TAC) per day over 7 days
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring the TAC per day. TAC is the total number of filtered, full-wave rectified, integrated accelerations (all directions). These will then be averaged/day based on the total number of valid wear days for each participant.
Measured: up to 7 days
Physical Activity Measured by Average Steps per day over 7 days
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean steps per day.
This will be quantified as reported by the ActiGraph accelerometer and ActiLife analysis software, which uses the vertical axis data. The Algorithm used by ActiGraph is not publicly available, but ActiGraph accelerometers are frequently used in research quantifying physical activity.
Measured: up to 7 days
Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: tri-axial counts
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean duration per day of MVPA.
Intensity of physical activity assessed using tri-axial counts (per the accelerometer software) are as follows: Light physical activity is between 200 and 2690 counts/min, moderate intensity between 2690-6166 counts/min, and vigorous intensity is ≥ 6167 counts/min. MVPA is ≥2690.
Measured: up to 7 days
Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: vertical counts
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean duration per day of MVPA.
Intensity of physical activity assessed using vertical counts (per the accelerometer software) are as follows: Light physical activity is between 100 and 759 counts/min, moderate intensity is 760-5999 counts/min, and vigorous intensity is ≥ 6000 counts/min (MVPA is > 760 counts/min).
Measured: up to 7 days
Average Minutes per Day of Activity in at least 5-minute bouts
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean duration per day of all activity.
Average minutes per day of activity within each of the following categories: light = 25.8 mg - 100.5 mg; moderate = 100.6 mg - 428.7 mg; vigorous = > 428.8 mg
(mg is the vector magnitude of acceleration calculated in gravities using Euclidean Norm minus 1 metric)
Measured: up to 7 days
Average Minutes per Day of Activity in at least 10-minute bouts
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean duration per day of all activity.
Average minutes per day of activity within each of the following categories: light = 25.8 mg - 100.5 mg; moderate = 100.6 mg - 428.7 mg; vigorous = > 428.8 mg.
(mg is the vector magnitude of acceleration calculated in gravities using Euclidean Norm minus 1 metric)
Measured: up to 7 days
Percent Change in Global Surface EMG Recordings: Abdominal Muscles
EMG will be reported as the root mean square (RMS) value. The percent change in EMG from the start of the task to task failure will be examined.
Measured: up to 10 days
Percent Change in Global Surface EMG Recordings: Rectus femoris
EMG for the rectus femoris will be normalized to the maximum RMS EMG obtained during lower extremity strength testing. The percent change in EMG from the start of the task to task failure will be examined.
Measured: up to 10 days
Mean Global Pittsburgh Sleep Quality Index (PSQI) Score
The PSQI assesses seven sleep domains: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The seven components scores are then added to yield a global PSQI score in the range of zero to 21. Higher scores indicate worse sleep quality. A global score greater than five is diagnostic of poor sleep quality.
Measured: up to 10 days
Mean Pelvic Floor Distress Inventory Short Form (PFDI-20) Score
The PFDI-20 is composed of 20 items total on three scales (Pelvic Organ Prolapse, Colorectal-Anal Distress, Urinary Distress), each scored on a 5 point likert scale. Mean scores from each scale are calculated and multiplied by 25, then added together for a total possible range of scores from 0-300. Higher scores indicate increased pelvic floor distress.
Measured: up to 10 days
Mean Oswestry Disability Index Score
This disability index measures how much lower back or leg pain affects the ability to manage everyday life. There are 10 sections, each section is scored from 0-5 for a total possible range of scores 0-50. The resultant score is divided by the total possible score and multiplied by 100 to get a percentage of disability.
Measured: up to 10 days
Mean Pain Catastrophizing Scale (PCS) Score
The PCS is a measure of thoughts and feelings when one is in pain. It is a 13 item questionnaire scored on a 5 point likert scale. The total possible range of scores is 0-52 where higher scores indicate a higher degree of overwhelm with respect to pain.
Measured: up to 10 days
Mean Edinburgh Postnatal Depression Scale (EPDS) Score
The EPDS is a 10-item survey that screens for symptoms of depression that have been present in the previous 7 days. Each question is scored on a 4-point scale ranging from 0 to 3 points for a total possible range of scores between 0-30, where higher scores indicate increased depression. Only postpartum participants will complete this survey.
Measured: up to 10 days
Mean Post Traumatic Stress Disorder (PTSD) Score
The PTSD Checklist for DSM-5 with Life Events Checklist for DSM-5 and Criterion A scale will be used to assess participant level of PTSD. The measure has a total range of scores between 0-80 with higher scores indicating greater PTSD symptoms.
Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
Measured: up to 10 days
Mean Tampa Scale for Kinesiophobia (TSK) Score
The TSK scale measures fear of movement. The total possible range of scores is 17-68, where higher score means higher degree of kinesiophobia.
Measured: up to 10 days
Mean Pelvic Girdle Questionnaire (PGQ) Score
The PGQ is a measure of how much pelvic girdle pain affects daily activities. It is a 25-item questionnaire scored on a 4 point likert scale for a total possible range of scores from 0-75 where higher scores indicate increased burden on daily activities.
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start20 Sep 2022
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Why it stopped: Personnel changes pending
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carroll University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Deering, Carroll University
- Investigators
- Rita Deering, PT, DPT, PhD, Principal investigator, Carroll University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073224
- Sponsor's protocol ID
- 2019-0275
- Other IDs
- A536130, Protocol Version 6/9/2020
- Status last verified
- Mar 2026
- First submitted
- 28 Sep 2021
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Biomechanics of the Lumbopelvic Stabilizing Muscles in Nulligravid and Postpartum Women
- ClinicalTrials.gov ID
- NCT05073224
- Acronym / sponsor ID
- 2019-0275
- Conditions
- Postpartum, Muscle Fatigue, Force Steadiness, Nulligravid, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Personnel changes pending
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Carroll UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 11 Oct 2021 (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.
This study will evaluate lower extremity and trunk neuromuscular control in 78 nulligravid and postpartum women. Participants will attend two experimental sessions, approximately 1 week apart, to assess neuromuscular function. Physical activity levels will also be assessed.
Detailed description
Stability of the lumbar spine and pelvis is essential to nearly all activities of daily living, and is achieved primarily by muscular stabilization. Recent studies have shown that postpartum women are more fatigable than nulligravid women during fatiguing tasks with the lumbopelvic stabilizing muscles (23%) and the trunk flexor muscles (52%) at six months postpartum. Postpartum women also demonstrate impaired control of force with the trunk flexor muscles; however, it is unknown if force control during a fatiguing task of the lumbopelvic stabilizing muscles is impaired in postpartum women.
This study has 3 purposes: (1) To quantify limb steadiness during fatiguing exercise of the lumbopelvic stabilizing muscles among nulligravid women and postpartum women; (2) to quantify muscle activity in the trunk, test limb and contralateral limb to provide insight into motor control; and (3) to identify possible factors (inter-recti distance (IRD), physical activity, pain, biopsychosocial factors) that contribute to neuromuscular function (fatigability and force control).
This is a novel, translational study that, for the first time, will quantify lower extremity force control in postpartum women. As this has not been studied before, to the best of the investigators' knowledge, this proposal will be a pilot study to establish means to utilize in power analyses for future studies of larger magnitude. Furthermore, neuromuscular function is not typically assessed clinically in postpartum women, and no tests exist to easily assess fatigability of the lumbopelvic stabilizing muscles in clinic settings. This study will also provide further data to highlight the ASLR Fatigue Task as a possible clinical examination tool and outcome measure to assess fatigability of the lumbopelvic stabilizing muscles.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postpartum | Experimental | Diagnostic Test: Active Straight Leg Raise Test, Other: Active Straight Leg Raise Fatigue Task, Other: Lower Extremity Strength Testing, Diagnostic Test: Ultrasound imaging of abdominal wallParticipants who are six months postpartum will complete 2 experimental sessions, separated by 7-10 days. Participants will complete multiple questionnaires, maximal voluntary contractions of the lower extremity muscles, clinical tests of lumbopelvic neuromuscular control/posterior pelvic pain provocation, and fatiguing lower extremity/trunk muscle exercise. Ultrasound imaging will be performed to measure inter-recti distance. Wireless Electromyography (EMG) sensors will be used to record EMG and limb steadiness (via Inertial Measurement Units (IMU). Physical activity will be measured by questionnaire and accelerometer. |
| Nulligravid | Active comparator | Diagnostic Test: Active Straight Leg Raise Test, Other: Active Straight Leg Raise Fatigue Task, Other: Lower Extremity Strength Testing, Diagnostic Test: Ultrasound imaging of abdominal wallParticipants who have never been pregnant will complete 2 experimental sessions, separated by 7-10 days. Participants will complete multiple questionnaires, maximal voluntary contractions of the lower extremity muscles, clinical tests of lumbopelvic neuromuscular control/posterior pelvic pain provocation, and fatiguing lower extremity/trunk muscle exercise. Ultrasound imaging will be performed to measure inter-recti distance. Wireless EMG sensors will be used to record EMG and limb steadiness (via IMUs). Physical activity will be measured by questionnaire and accelerometer. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Post-partum
- Primiparous (this is their first child)
Key exclusion criteria (9 listed)
- multiple gestation
- prescription anti-inflammatory/pain medications that are taken daily
- significant orthopedic conditions that would contraindicate performance of the fatigue task (such as fractures, severe scoliosis, etc)
- cardiovascular \& pulmonary disease
- neuromuscular health conditions (such as diabetes, neuropathy, multiple sclerosis, stroke, seizures, etc)
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 |
|---|---|---|
| Active Straight Leg Raise TestAlso: ASLR TestThe ASLR test is a well-established clinical test that assesses stability of the lumbar spine/pelvis, posterior pelvic pain severity, and ability to activate the abdominal muscles. It is performed in supine. Participants are instructed to raise one leg, with the knee straight, to a heel height of 20 cm. The leg is held at the top for 5 seconds, then slowly lowered to the ground. The participant is asked to report perceived difficulty to raise the leg on a 0 to 5 scale (0=not at all difficult; 5=unable to lift leg) and pain on a 0 to 10 scale (0=no pain; 10=worst possible pain). If difficulty or pain are rated at a 1 or higher, the test is repeated with the researcher providing external compression of the pelvis. If perceived difficulty or reported pain are lower with compression, the test is considered positive for lumbopelvic instability. The test is then repeated on the opposite limb. | Diagnostic test | Nulligravid, Postpartum |
| Active Straight Leg Raise Fatigue TaskAlso: ASLR Fatigue TaskThe protocol is similar to the ASLR test, except that the participant is instructed to maintain the elevated leg off the ground for as long as possible. A biofeedback air cuff will be placed under the participant's lumbopelvic region to assess movement of the spine/pelvis. The cuff will be inflated to 40 mm Hg, and the participant instructed to keep the needle as close to 40 mm Hg as possible throughout the test; no information will be provided on how to affect cuff pressure, but visual feedback of cuff pressure will be provided throughout the task. Ratings of perceived exertion (RPE) and pain will be obtained from participants every 30-60 seconds. Task failure will be defined as a heel height ≤10 cm or a change in cuff pressure ≥20 mm Hg. Both limbs will be tested, but in different sessions. The order of limb testing (dominant vs non-dominant) will be randomized and counter-balanced. Limb dominance will be self-reported. | Other | Nulligravid, Postpartum |
| Lower Extremity Strength TestingA straight leg raise maximal voluntary contraction (MVC) of each lower extremity an MVC of the hip extensors of the grounded limb will be performed in supine before and within 2 minutes of completing the ASLR fatigue task. The straight leg raise MVC will be performed with a custom-made load cell instrumented strength testing device, which consists of a rigid platform on which the participant will lie. At the foot of the device is a tower that houses 2 load cells connected to a lightly padded push plate. The hip extension MVC will be performed on a force plate. Before the ASLR fatigue task, a minimum of 3 MVC trials will be performed for each muscle group, with a minimum of 1 minute rest between trials; the highest peak force will be considered the MVC. Only 1 MVC trial per muscle group will be performed following the ASLR Fatigue Task. | Other | Nulligravid, Postpartum |
| Ultrasound imaging of abdominal wallReal time ultrasound will be used to assess inter-recti distance above and below the umbilicus. Participants will be assessed with B Mode images in supine at rest, in supine while lifting their head, and in supine while performing a straight leg raise. The Principle Investigator has training and experience in musculoskeletal ultrasound. | Diagnostic test | Nulligravid, Postpartum |
Primary outcome
Incidence of Posterior Pelvic Pain
Time frame: up to 10 days
The Active Straight Leg Raise (ASLR) test is a well-established clinical test that assesses stability of the lumbar spine/pelvis, posterior pelvic pain severity, and ability to activate the abdominal muscles. It is performed in supine. Participants are instructed to raise one leg, with the knee straight, to a heel height of 20 cm. The leg is held at the top for 5 seconds, then slowly lowered to the ground. The participant is asked to report pain on a 0 to 10 scale (0=no pain; 10=worst possible pain). The test is then repeated on the opposite limb.
Incidence of Perceived Difficulty with ASLR Task
Time frame: up to 10 days
The Active Straight Leg Raise (ASLR) test is a well-established clinical test that assesses stability of the lumbar spine/pelvis, posterior pelvic pain severity, and ability to activate the abdominal muscles. It is performed in supine. Participants are instructed to raise one leg, with the knee straight, to a heel height of 20 cm. The leg is held at the top for 5 seconds, then slowly lowered to the ground. The participant is asked to report perceived difficulty to raise the leg on a 0 to 5 scale (0=not at all difficult; 5=unable to lift leg). The test is then repeated on the opposite limb.
Incidence of Lumbopelvic Instability
Time frame: up to 10 days
The Active Straight Leg Raise (ASLR) test is a well-established clinical test that assesses stability of the lumbar spine/pelvis, posterior pelvic pain severity, and ability to activate the abdominal muscles. It is performed in supine. Participants are instructed to raise one leg, with the knee straight, to a heel height of 20 cm. The leg is held at the top for 5 seconds, then slowly lowered to the ground. The participant is asked to report perceived difficulty to raise the leg on a 0 to 5 scale (0=not at all difficult; 5=unable to lift leg) and pain on a 0 to 10 scale (0=no pain; 10=worst possible pain). If difficulty or pain are rated at a 1 or higher, the test is repeated with the researcher providing external compression of the pelvis. If perceived difficulty or reported pain are lower with compression, the test is considered positive for lumbopelvic instability. The test is then repeated on the opposite limb.
Mean Time to ASLR Fatigue Task Failure
Time frame: up to 10 days
For the ASLR Fatigue Task, the participant is instructed to maintain the elevated leg off the ground for as long as possible. Task failure will be defined as a heel height greater than or equal to 10 centimeters off the ground.
Maximum Lower Extremity Strength: Leg
Time frame: up to 10 days
A straight leg raise maximal voluntary contraction (MVC) of each lower extremity will be performed in the supine position before and within 2 minutes of completing the ASLR fatigue task with a custom made load cell instrumented strength testing device. This device consists of a rigid platform on which the study participant will lie supine. At the foot of the device is a tower that houses 2 load cells and is connected to a lightly padded push plate. This push plate can be raised and lowered such that the participant can push up into the plate (contacts the anterior surface of the participant's shin) or push down onto the push plate (contacts the posterior aspect of the participant's heel). Before the ASLR fatigue task, a minimum of 3 MVC trials will be performed on each leg, with a minimum of 1 minute rest between trials, in order to ensure a true maximum has been obtained; the highest peak force will be considered the MVC. Only 1 MVC trial per leg will be performed following the
Maximum Lower Extremity Strength: Hip Extension
Time frame: up to 10 days
A hip extension MVC will also be performed in supine (pushing down into the ground) on a force plate (1000 Hz) prior to performance of the ASLR fatigue task. Only the leg that will remain in contact with the force plate during the ASLR fatigue task (grounded limb) will perform the extension MVC, in order to normalize downward pressure into the force plate by the grounded limb during performance of the ASLR fatigue task. This will allow us to quantify activity of the grounded limb during the fatiguing task. A minimum of 3 hip extension MVCs will be performed, with 1 minute rest between trials. An MVC may also be assessed at the end of the fatiguing exercise bout.
Limb Steadiness Measured by Limb Acceleration
Time frame: up to 10 days
An inertial measurement unit (Trigno, Delsys, Boston, MA) will be placed on the test limb to track movement of the limb during performance of the ASLR Fatigue Task. Fluctuations in limb acceleration will be measured and quantified as the standard deviation of acceleration. Limb steadiness will be collected online, stored, and analyzed offline with ConsensysPRO software. The investigators hypothesize that fluctuations in limb acceleration will be greater among postpartum women as compared to nulligravid women during the performance of the ASLR Fatigue Task.
Abdominal Fascial Integrity Measured by Mean Inter-Recti Distance
Time frame: up to 10 days
Real time ultrasound will be used to assess inter-recti distance above and below the umbilicus. Participants will be assessed with B Mode images in supine at rest, in supine while lifting their head, and in supine while performing a straight leg raise.
18 secondary outcomes
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Ratings of Perceived Exertion (RPE)
Time frame: up to 10 days
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
Time frame: up to 10 days
Average Total Activity Counts (TAC) per day over 7 days
Time frame: up to 7 days
Physical Activity Measured by Average Steps per day over 7 days
Time frame: up to 7 days
Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: tri-axial counts
Time frame: up to 7 days
Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: vertical counts
Time frame: up to 7 days
Average Minutes per Day of Activity in at least 5-minute bouts
Time frame: up to 7 days
Average Minutes per Day of Activity in at least 10-minute bouts
Time frame: up to 7 days
Percent Change in Global Surface EMG Recordings: Abdominal Muscles
Time frame: up to 10 days
Percent Change in Global Surface EMG Recordings: Rectus femoris
Time frame: up to 10 days
Mean Global Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: up to 10 days
Mean Pelvic Floor Distress Inventory Short Form (PFDI-20) Score
Time frame: up to 10 days
Mean Oswestry Disability Index Score
Time frame: up to 10 days
Mean Pain Catastrophizing Scale (PCS) Score
Time frame: up to 10 days
Mean Edinburgh Postnatal Depression Scale (EPDS) Score
Time frame: up to 10 days
Mean Post Traumatic Stress Disorder (PTSD) Score
Time frame: up to 10 days
Mean Tampa Scale for Kinesiophobia (TSK) Score
Time frame: up to 10 days
Mean Pelvic Girdle Questionnaire (PGQ) Score
Time frame: up to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Rita Deering, PT, DPT, PhD principal investigator
Carroll University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Straight Leg Raise Test, Active Straight Leg Raise Fatigue Task and Lower Extremity Strength Testing in people with Postpartum and Muscle Fatigue, run by Carroll University at 1 site in United States.
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 2 inclusion and 9 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: paused, as of the sponsor's last update on 10 Mar 2026. 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 United States. 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?
Results are not available in the source record.
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?
Incidence of Posterior Pelvic Pain (time frame: up to 10 days). The study lists 8 primary outcomes in all. 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 10 Mar 2026.