跳至主要内容
临床试验/NCT07515144
NCT07515144Enrolling By Invitation不适用

Effect of Lower Limb Neural Mobilization on Selective Neuromuscular Variables and Calf Muscle Thickness in Elderly Population With Sarcopenia

INTI International University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年11月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
52
试验地点
1
主要终点
Calf Muscle Thickness

研究概览

简要总结

Sarcopenia is a common age-related condition characterized by a gradual loss of muscle mass, strength, and physical performance. This can make everyday activities such as walking, standing, and maintaining balance more difficult for older adults, increasing the risk of falls and reducing independence. The lower limb muscles, especially the calf muscles, play an essential role in movement and stability. When these muscles weaken, it can significantly affect balance and mobility. While traditional management of sarcopenia focuses on strengthening exercises and nutrition, there is increasing interest in approaches that also target the nervous system to improve overall function.

This study aims to examine the effect of lower limb neural mobilization on selected neuromuscular variables, namely static balance, fall risk, and ankle muscle strength as well as calf muscle thickness in elderly individuals with sarcopenia. Neural mobilization is a physiotherapy technique designed to improve the movement and flexibility of nerves. In the lower limbs, nerves such as the sciatic, tibial, and common peroneal nerves are responsible for transmitting signals between the brain and muscles. With aging or reduced activity, these nerves may become less mobile, which can affect muscle activation and coordination. Neural mobilization involves gentle, controlled movements that help restore normal nerve mobility, improve blood flow, and enhance communication between the nerves and muscles.

In this study, static balance refers to the ability to maintain a stable standing position without losing balance. Fall risk indicates the likelihood of experiencing a fall, which is a major concern in older adults. Ankle muscle strength is crucial because the ankle plays a key role in maintaining posture and responding to balance disturbances. Calf muscle thickness is an indicator of muscle mass and is commonly measured using imaging techniques such as ultrasound. Together, these measures provide a comprehensive understanding of an individual's physical function and safety.

Participants in this study will typically be individuals aged 60 years and above with sarcopenia. They will first undergo assessments to evaluate their balance, fall risk, ankle strength, and calf muscle thickness. Following this, they will participate in a structured program involving lower limb neural mobilization, which may be combined with OTAGO exercises. The intervention will be conducted by trained professionals over a set period. After completing the program, participants will be reassessed to determine any improvements.

Neural mobilization is a safe and non-invasive technique, and participants may only feel a gentle stretching sensation during the procedure. The potential benefits include improved balance, increased ankle strength, reduced risk of falls, and enhanced muscle size. These improvements can lead to better mobility, greater independence, and improved quality of life. For families and healthcare providers, this study highlights the importance of combining muscle and nerve-focused treatments in managing sarcopenia. Overall, this research aims to support more effective rehabilitation strategies for healthy aging and fall prevention in the elderly population.

详细描述

Sarcopenia is a progressive and generalized skeletal muscle disorder associated with aging, characterized by a decline in muscle mass, muscle strength, and physical performance. It is increasingly recognized as a major contributor to frailty, disability, hospitalization, and reduced quality of life among older adults. With the global rise in life expectancy, the prevalence of sarcopenia is expected to increase substantially, posing significant challenges to healthcare systems and caregivers. The condition is multifactorial in nature, involving complex interactions between biological aging processes, reduced physical activity, hormonal changes, chronic low-grade inflammation, nutritional deficiencies, and neuromuscular degeneration. Among these contributing factors, impairments in the neuromuscular system have gained increasing attention, as they play a crucial role in determining muscle function, coordination, and overall physical performance in elderly individuals.

Aging is associated with structural and functional changes in both the central and peripheral nervous systems. There is a gradual loss of motor neurons, resulting in a reduced number of motor units, as well as remodeling of remaining motor units through collateral reinnervation. Although this compensatory mechanism may initially help maintain muscle function, it eventually becomes insufficient, leading to decreased motor unit firing rates, impaired neuromuscular transmission, and reduced efficiency of muscle activation. Additionally, peripheral nerves undergo age-related changes such as reduced nerve conduction velocity, decreased elasticity, and increased susceptibility to mechanical stress. These neural alterations can contribute to impaired coordination, delayed reflex responses, and decreased proprioceptive input, all of which are essential for maintaining balance and preventing falls. Consequently, the decline in neuromuscular function is a critical component of sarcopenia and significantly impacts the functional independence of older adults.

The lower limbs are particularly affected in sarcopenia, as they are responsible for weight-bearing activities, locomotion, and postural control. Among the lower limb muscle groups, the calf muscles, comprising the gastrocnemius and soleus, play a vital role in maintaining upright posture, generating propulsive force during gait, and stabilizing the ankle joint. These muscles are essential for activities such as walking, standing, climbing stairs, and responding to balance disturbances. A reduction in calf muscle thickness is commonly observed in elderly individuals with sarcopenia and is associated with decreased muscle strength, impaired mobility, and increased risk of falls. Measurement of calf muscle thickness using ultrasound imaging provides a reliable and non-invasive method to assess muscle morphology and monitor changes over time, making it a valuable outcome measure in clinical and research settings.

Falls are one of the most serious and common consequences of sarcopenia in the elderly population. They are a leading cause of injury, fractures, hospitalization, and mortality among older adults, and often result in a cycle of fear of falling, reduced physical activity, and further functional decline. The risk of falls is influenced by multiple factors, including muscle weakness, impaired balance, delayed reaction time, sensory deficits, and environmental hazards. Among these factors, deficits in neuromuscular function play a central role. Static balance, defined as the ability to maintain a stable posture while standing without movement, is a fundamental component of postural control and is essential for preventing falls during daily activities. It requires the integration of visual, vestibular, and somatosensory inputs, along with appropriate motor responses to maintain equilibrium. Impairments in static balance are commonly observed in individuals with sarcopenia and are strongly associated with an increased risk of falls.

Ankle muscle strength is another critical determinant of balance and fall prevention. The ankle joint is responsible for executing rapid and precise adjustments to maintain stability in response to external perturbations. The ankle strategy is often the first line of defense in maintaining balance during small disturbances. Weakness in the ankle dorsiflexor and plantar flexor muscles can compromise this strategy, leading to instability and increased reliance on less efficient compensatory mechanisms such as hip or stepping strategies. Therefore, improving ankle muscle strength is essential for enhancing postural control and reducing fall risk in elderly individuals with sarcopenia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

This study employs single blinding in which the outcome assessor is blinded to group allocation. Participants and treating physiotherapists are not blinded due to the nature of the interventions. All outcome measures, including static balance, fall risk, ankle muscle strength, and calf muscle thickness, will be assessed by an independent assessor who is unaware of the participant group assignments.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants of both genders aged 60 years and above are included. A Mini-Mental State Examination (MMSE) score of 24-30 is required, indicating normal to mild cognitive function.
  • Sarcopenia is diagnosed according to the criteria established by the European Working Group on Sarcopenia in Older People (EWGSOP).

排除标准

  • Individuals with neurological disorders are excluded. Individuals with severe musculoskeletal impairments that restrict ankle movement or prevent safe participation in stretching exercises are excluded.
  • Participants currently undergoing other physical therapy interventions are excluded.
  • Individuals using medications that significantly affect balance, muscle strength, or central nervous system function are excluded.
  • Individuals with a recent history of lower limb surgery or trauma are excluded.

研究组 & 干预措施

Neural Mobilization and Otago Exercise Group

Experimental

Experimental Group - Participants will receive lower limb neural mobilization along with the Otago Exercise Program (OEP). Neural mobilization involves gentle, guided movements of the hip, knee, and ankle to improve nerve mobility. The OEP includes balance and strengthening exercises for the legs. Sessions are 3 times per week for 8 weeks, with neural mobilization for 30-40 minutes and OEP for 20-30 minutes each session

干预措施: Neural Mobilization (Other)

Neural Mobilization and Otago Exercise Group

Experimental

Experimental Group - Participants will receive lower limb neural mobilization along with the Otago Exercise Program (OEP). Neural mobilization involves gentle, guided movements of the hip, knee, and ankle to improve nerve mobility. The OEP includes balance and strengthening exercises for the legs. Sessions are 3 times per week for 8 weeks, with neural mobilization for 30-40 minutes and OEP for 20-30 minutes each session

干预措施: Otago Exercise (Other)

Otago exercise Group

Active Comparator

Participants will receive the Otago Exercise Program (OEP) only, which includes leg strengthening and balance exercises. Sessions are 3 times per week for 8 weeks, 20-30 minutes each.

干预措施: Otago Exercise (Other)

结局指标

主要结局

Calf Muscle Thickness

时间窗: The outcome will be measured at baseline, 4th week and end of 8th week

Ultrasound will be utilized to assess the muscle thickness of the calf muscle. Ultrasound imaging is an effective, non-invasive method in which high-frequency sound waves can be used to view inside the body. The measurement procedure begins with participants lying in a prone position, with their legs extended and relaxed, and their feet hanging off the edge of the bed. The examiner places the ultrasound probe (2-10 MHz, Aixplorer; Aix-en-Provence, France) against the skin, ensuring the beam is perpendicular to the skin surface. The probe is then directed at the medial cross-section of the medial head of the gastrocnemius muscle, locating the largest cross-sectional area as the reference section, and marking the corresponding area on the body surface. Ultrasound measurements are taken for fat thickness and muscle thickness in the axial view.

次要结局

  • Ankle Muscle Strength(Baseline, 4th week and at end of 8th week)
  • Static Balance(Baseline, 4th week and at the end of 8th week)
  • Fall Risk(Baseline, 4th week and at the end of the 8th week)

研究者

发起方
INTI International University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Premavati Lekshmanan

Clinical Instructor

INTI International University

研究点 (1)

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