Protocols and Guidelines for the Use of Digital Twins in Frail Older People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Co-contraction index (CCI)
研究概览
简要总结
The Proto-Aging study aims to define experimental protocols and guidelines to enable the development of musculoskeletal models (digital twins) of elderly people, with the ultimate goal to comprehensively characterize frail elders from a biomechanical standpoint.
It is typical for the elderly to present with weakness, slowed movements and reduced levels of physical activity, all of which may be related to the loss of muscle force (dynapenia). Unfortunately, to date, the primary cause for dynapenia is difficult to identify. Digital twins may help to this end, but their development remains critical as it requires a specialized skillset and experimental data for model personalisation.
In this study, where the investigators will recruit a small group of frail elders and a cohort of healthy young individuals, all participants will undergo the following examinations: (i) gait assessment, (ii) maximal voluntary isometric contraction (MVIC) test, (iii) superimposed neuromuscular electrical stimulation, and (iv) full lower limb magnetic resonance imaging. Surface electromyography data will further be collected while the subjects perform both the gait assessment and the MVIC test. Last, clinical questionnaires will be administered, and the subjects will be asked to perform additional clinical measures (i.e., hand-grip test, bioelectrical impedance analysis).
At the end of the study, a reduced version of the experimental protocol will be developed, with the intent to provide clinicians with a protocol that can be deployed in clinical settings, accounting for the observed reliability and repeatability of each measure, the required level of expertise, and the associated costs and time expenditure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 65-80 years
- •Body Mass Index between 18.5 and 30 kg/m2
- •Frailty syndrome diagnosed according to Fried's criteria (i.e., at least three of the following items: unintended loss of weight, weakness, self-reported exhaustion, slow walking speed, low level of physical activity)
排除标准
- •Any musculoskeletal, neurological, rheumatic or tumoral diseases
- •Inguinal or abdominal hernia
- •Severe Hypertension (Level 3)
- •Severe Cardio-pulmonary insufficiency
- •Diagnosis of Osteonecrosis in the lower limb joints
- •Pathologies or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (i.e., active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs)
- •Previous interventions or traumas to the joints of the lower limb
- •NOTE: A group of healthy volunteers, who meet the following criteria, will be enrolled in the study:
- •Inclusion Criteria:
- •Age: 20-40 years;
- •Body Mass Index: 15-30 kg/m²;
- •Physical activity level (Saltin-Grimby): 2-4
- •No previous or known musculoskeletal, neurological, rheumatic or tumoral diseases
结局指标
主要结局
Co-contraction index (CCI)
时间窗: at baseline (Day 0)
Experimental EMG data will be recorded from the major lower limb muscles involved in the knee extension, while participants perform a maximal voluntary isometric contraction on a dynamometer (i.e., MVIC test to quantify muscle strength). The co-contraction index, defined as the relative activation of agonist and antagonist muscles (for this task: quadriceps and hamstrings) in the act of kicking (MVIC test).
Muscle Inhibition level
时间窗: at baseline (Day 0)
The difference between the maximal force exerted during the MVIC test (voluntary contraction) and that achieved when the muscles are electrically stimulated (involuntary contraction) will be computed
Muscle volume
时间窗: at baseline (Day 0)
Full lower limb MRI data will be acquired with subjects in supine position. Individual muscle volumes (in cm3) will be segmented using commercial software and stored in anonymized form.
MVIC Torque
时间窗: at baseline (Day 0)
Dynamometry data will be acquired while participants perform a MVIC leg extension test. The maximum torque values (Nm) measured over three repetitions will be recorded. These correspond to the values observed in correspondence of the plateaux of force, developed over a sustained contraction
Body kinematics
时间窗: at baseline (Day 0)
A standard gait assessment will be performed where motion capture data will be collected. Joint angles will be extracted to identify abnormal gait patterns.
次要结局
未报告次要终点