Neuromuscular Biomechanics of the Lumbopelvic Stabilizing Muscles in Nulligravid and Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Mean Time to ASLR Fatigue Task Failure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post-partum
- •Primiparous (this is their first child)
排除标准
- •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)
- •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
研究组 & 干预措施
Postpartum
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.
干预措施: Active Straight Leg Raise Test (Diagnostic Test)
Postpartum
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.
干预措施: Active Straight Leg Raise Fatigue Task (Other)
Postpartum
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.
干预措施: Lower Extremity Strength Testing (Other)
Postpartum
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.
干预措施: Ultrasound imaging of abdominal wall (Diagnostic Test)
Nulligravid
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.
干预措施: Active Straight Leg Raise Test (Diagnostic Test)
Nulligravid
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.
干预措施: Active Straight Leg Raise Fatigue Task (Other)
Nulligravid
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.
干预措施: Lower Extremity Strength Testing (Other)
Nulligravid
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.
干预措施: Ultrasound imaging of abdominal wall (Diagnostic Test)
结局指标
主要结局
Mean Time to ASLR Fatigue Task Failure
时间窗: 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.
Incidence of Posterior Pelvic Pain
时间窗: 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
时间窗: 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
时间窗: 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.
Maximum Lower Extremity Strength: Leg
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Physical Activity Measured by Average Steps per day over 7 days(up to 7 days)
- Mean Global Pittsburgh Sleep Quality Index (PSQI) Score(up to 10 days)
- Mean Pelvic Girdle Questionnaire (PGQ) Score(up to 10 days)
- Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Ratings of Perceived Exertion (RPE)(up to 10 days)
- Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score(up to 10 days)
- Average Total Activity Counts (TAC) per day over 7 days(up to 7 days)
- Average Minutes per Day of Activity in at least 5-minute bouts(up to 7 days)
- Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: tri-axial counts(up to 7 days)
- Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: vertical counts(up to 7 days)
- Percent Change in Global Surface EMG Recordings: Rectus femoris(up to 10 days)
- Average Minutes per Day of Activity in at least 10-minute bouts(up to 7 days)
- Percent Change in Global Surface EMG Recordings: Abdominal Muscles(up to 10 days)
- Mean Pelvic Floor Distress Inventory Short Form (PFDI-20) Score(up to 10 days)
- Mean Oswestry Disability Index Score(up to 10 days)
- Mean Pain Catastrophizing Scale (PCS) Score(up to 10 days)
- Mean Post Traumatic Stress Disorder (PTSD) Score(up to 10 days)
- Mean Edinburgh Postnatal Depression Scale (EPDS) Score(up to 10 days)
- Mean Tampa Scale for Kinesiophobia (TSK) Score(up to 10 days)
研究者
Rita Deering
Associate Professor
Carroll University