Longitudinal Ultrasound Kinematic Evaluation of Digastric Muscles
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to evaluate the rate of interpretable ultrasound measurements (feasibility) of the anterior bellies of the digastric muscles obtained using a new ultrasound approach employing a longitudinal section
研究概览
简要总结
Ultrasound applied to the upper aerodigestive tract for the assessment of swallowing disorders has been the subject of numerous publications in recent years. Changes in the range of motion or muscular characteristics of the structures involved in swallowing are associated with the presence of swallowing disorders. However, current assessment remains limited to morphological parameters at rest, whereas the combined analysis of measurements at rest and during contraction is a recognised indicator of muscle activity and recruitment capacity in other areas (diaphragm, pelvic floor).
For the anterior bellies of the digastric muscles, which are central to hyo-laryngeal kinematics during swallowing, the conventional transverse ultrasound approach yields a non-interpretability rate of approximately 30% at rest and exceeding 50% during dynamic assessment, along with insufficient reproducibility. These limitations prevent reliable access to functional muscle parameters such as thickness variation during contraction and pennation angle.
This single-centre, cross-over study aims to evaluate whether a proposed new ultrasound approach (NAEP), based on a longitudinal (sagittal) probe positioning, achieves a significantly higher rate of interpretable measurements compared to the conventional approach. The study enrolls 35 healthy volunteers and 35 patients with dysphagia. Both approaches are applied during the same session for each participant, across four swallowing conditions (dry swallow, 5, 10, and 20 mL water boluses). Secondary objectives include assessment of intra- and inter-rater reliability of the NAEP, analysis of the impact of bolus volume on muscle contraction and hyoid movement, and comparison of morphometric parameters between healthy subjects and dysphagic patients.
详细描述
Background and technical information :
Ultrasound assessment of the anterior bellies of the digastric muscles (ABDM) has historically relied on a transverse (cross-sectional) approach placing the probe in the submental region. This conventional approach (CA) yields a non-interpretability rate of approximately 30% at rest and exceeding 50% during dynamic swallowing assessment, with poor reproducibility, preventing reliable access to functional muscle parameters such as thickness variation during contraction or pennation angle.
The proposed new ultrasound approach (NAEP) involves repositioning the probe to obtain a longitudinal (sagittal) section of the ABDM by rotating the probe 90° from the cross-sectional plane and applying a lateral displacement to align the muscle fibres along their axis. This approach is hypothesised to improve image interpretability and provide access to the pennation angle, a parameter not measurable with the CA.
All examinations are performed using a Sonoscape Expert 2 ultrasound scanner (7-10 MHz high-frequency linear probe), with the participant seated.
Study procedures Healthy volunteers: Each participant undergoes a single-session ultrasound assessment (≤45 minutes total) including image acquisition during four swallowing conditions - dry swallow and 5, 10, and 20 mL water boluses - in a randomised order (block randomisation, n=4). Both the NAEP and CA are applied to each condition, with the order of approaches also randomised at the subject level. Each bolus volume is assessed once per approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For healthy volunteers:
- •Aged 18 years or over
- •Verbal, free, informed and express consent from the subject
- •For subjects with swallowing disorder
- •Subjects admitted to Forcilles Hospital to one of the short-stay or medical care and rehabilitation departments for diabetes and obesity, respiratory medicine, oncology, ENT and gastro-nutrition at Forcilles Hospital;
- •Subjects who have undergone an assessment of swallowing disorders by a speech and language therapist;
- •Subjects aged 18 or over at the time of inclusion;
- •Enrolment in a social security scheme or eligibility for such a scheme;
- •Verbal, free, informed and express consent from the patient.
排除标准
- •For healthy volunteers :
- •Under 18 years of age
- •With a history of swallowing disorders
- •With a medical history that could cause a swallowing disorder: stay in intensive care with orotracheal intubation; neurological or neuromuscular disease; cancer of the upper aerodigestive tract
- •For Subjects with swallowing disorders
- •Patients for whom there is no indication for swallowing tests;
- •Individuals subject to a court-ordered protective measure;
- •Patients under guardianship or administration;
- •Patients subject to a care restriction order.
结局指标
主要结局
The primary objective of this study is to evaluate the rate of interpretable ultrasound measurements (feasibility) of the anterior bellies of the digastric muscles obtained using a new ultrasound approach employing a longitudinal section
时间窗: During a single experimental session, at the time of ultrasound acquisition
For each swallowing condition (dry swallow, 5 mL, 10 mL, and 20 mL water bolus), an ultrasound image is classified as interpretable if both superficial and deep muscular fasciae of the anterior belly of the digastric muscle are identifiable over at least 50% of the visualised muscle length, allowing reliable caliper placement for thickness measurement at rest and during contraction. Images not meeting these criteria are classified as non-interpretable. The feasibility rate is expressed as the proportion of interpretable images per swallow (with 95% CI) for each approach (NAEP and conventional approach), and compared using a mixed-effects logistic regression model adjusted for bolus volume, group, and order of administration. A higher proportion indicates better feasibility.
次要结局
- Intraclass Correlation Coefficient (ICC) for NAEP measurements of anterior belly of digastric muscle thickness(During a single experimental session, assessed in healthy volunteers only (two consecutive examinations per operator, separated by 5 minutes). Echographers will be blinded.)
- Change in anterior belly of digastric muscle thickness according to swallowed bolus volume(During a single experimental session, at the time of ultrasound acquisition)
- Hyoid bone displacement according to swallowed bolus volume(During a single experimental session, at the time of ultrasound acquisition)
- Rate of interpretable images for pennation angle measurement of the anterior bellies of the digastric muscles using the NAEP(During a single experimental session, at the time of ultrasound acquisition)
- Correlation between change in anterior belly of digastric muscle thickness and hyoid bone displacement during swallowing(During a single experimental session, at the time of ultrasound acquisition)
- Correlation between change in pennation angle of the anterior bellies of the digastric muscles and hyoid bone displacement during swallowing(During a single experimental session, at the time of ultrasound acquisition)
- Comparison of ultrasound morphometric parameters of the anterior bellies of the digastric muscles between healthy volunteers and patients with dysphagia(During a single experimental session, at the time of ultrasound acquisition)