- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07515144
Impact of Lower Limb Neural Mobilization on Neuromuscular Function and Calf Muscle Thickness in Elderly Individuals With Sarcopenia
Effect of Lower Limb Neural Mobilization on Selective Neuromuscular Variables and Calf Muscle Thickness in Elderly Population With Sarcopenia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Traditional rehabilitation approaches for sarcopenia have primarily focused on resistance training, balance exercises, and nutritional interventions aimed at improving muscle mass and strength. While these interventions have demonstrated effectiveness, they may not fully address the neural components of muscle dysfunction. There is growing evidence to suggest that optimizing neural function can enhance the effectiveness of rehabilitation and lead to better functional outcomes. Neural mobilization is an emerging therapeutic technique that targets the peripheral nervous system and aims to restore the normal mobility and function of neural tissues. It involves the application of specific, controlled movements that promote the sliding and gliding of nerves relative to surrounding structures, thereby reducing mechanical restrictions, improving neural elasticity, and enhancing blood flow and axoplasmic transport within the nerve.
In the lower limb, neural mobilization techniques commonly target the sciatic nerve and its branches, including the tibial and common peroneal nerves. These nerves are responsible for innervating the muscles of the leg and foot, as well as providing sensory feedback necessary for balance and coordination. With aging, these nerves may become less mobile due to factors such as decreased tissue elasticity, prolonged inactivity, or degenerative changes in surrounding structures. Restricted neural mobility can lead to increased neural tension, impaired signal transmission, and reduced muscle activation. Neural mobilization techniques, such as slider and tensioner methods, are designed to restore normal nerve movement and improve neural function without causing discomfort. The slider technique involves simultaneous movement at two joints to promote nerve gliding, while the tensioner technique increases tension along the nerve pathway to improve its mechanical properties.
The present study aims to investigate the effect of lower limb neural mobilization on selective neuromuscular variables, specifically static balance, fall risk, and ankle muscle strength, as well as calf muscle thickness in elderly individuals with sarcopenia. This study is designed as a randomized controlled trial involving participants aged 60 years and above who meet the diagnostic criteria for sarcopenia. Participants will be recruited from community settings, outpatient clinics, or rehabilitation centers and will undergo a thorough screening process to ensure eligibility. Inclusion criteria include reduced muscle mass, decreased muscle strength, and impaired physical performance, while exclusion criteria may include severe cognitive impairment, neurological disorders, recent musculoskeletal injuries, or contraindications to physiotherapy interventions. Informed consent will be obtained from all participants prior to their inclusion in the study.
Baseline assessments will be conducted to evaluate all outcome measures. Static balance will be assessed using standardized clinical test which is single-leg stance test. Fall risk will be evaluated using validated tool, Timed Up and Go test. Ankle muscle strength will be measured using handheld dynamometry to quantify the force generated by the dorsiflexor and plantarflexor muscle groups. Calf muscle thickness will be assessed using ultrasound imaging to provide an objective measure of muscle morphology.
Participants will then be randomly allocated into an intervention group or a control group. The intervention group will receive lower limb neural mobilization in addition to OTAGO exercises, while the control group will receive only OTAGO exercises. Neural mobilization will be administered by trained physiotherapists using standardized protocols to ensure consistency and reproducibility. The intervention will be conducted over a period of 8 weeks, with sessions performed three times per week. Participants will be closely monitored for adherence, safety, and any adverse effects throughout the study period.
Following the intervention, post-assessments at week 4 and week 8 will be conducted using the same outcome measures as at baseline. Data analysis will involve comparing pre- and post 4th week and 8th week intervention values within and between groups to determine the effectiveness of neural mobilization. It is hypothesized that participants in the intervention group will demonstrate significant improvements in static balance, reduced fall risk, increased ankle muscle strength, and enhanced calf muscle thickness compared to the control group.
The expected results of this study are based on the premise that improving neural mobility can enhance neuromuscular efficiency. Neural mobilization may facilitate better nerve conduction, reduce mechanosensitivity, and improve the synchronization of motor unit recruitment, leading to more effective muscle contractions. Improved ankle strength is likely to contribute to better postural control and stability, thereby reducing fall risk. Enhanced proprioceptive input from the lower limbs may further improve balance and coordination. Additionally, increased muscle activation may stimulate muscle hypertrophy, resulting in increased calf muscle thickness.
In conclusion, this study seeks to explore a comprehensive approach to managing sarcopenia by addressing both neural and muscular components. By integrating neural mobilization into rehabilitation programs, it may be possible to enhance functional outcomes, reduce fall risk, and improve quality of life in elderly individuals. The findings of this study have the potential to contribute to the development of evidence-based interventions for geriatric rehabilitation and promote healthy aging in the growing elderly population.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Negeri Sembilan
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Seremban, Negeri Sembilan, Malaysia, 70100
- Mercy Convalescent & Nursing Home
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria 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).
Exclusion Criteria 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neural Mobilization and Otago Exercise Group
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
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Participants in the control group will receive Otago Exercise for a period of 30 minutes.
This exercise components are specifically focused to enhance Balance, Strength of the lower extremity.
Neural Mobilization + Otago Exercises Intervention Description: 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. Common peroneal and tibial nerve were mainly focused on this intervention. Each nerve mobilized for 5 set with 10 repetitions with 60 seconds of rest period between the set. Along with the Neural Mobilization this group also undergo Otago Exercise which consist of Balance, Strengthening and Stretching exercises for the Lower limb for a period of 30 minutes. |
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Active Comparator: Otago exercise Group
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.
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Participants in the control group will receive Otago Exercise for a period of 30 minutes.
This exercise components are specifically focused to enhance Balance, Strength of the lower extremity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Calf Muscle Thickness
Time Frame: The outcome will be measured at baseline, 4th week and end of 8th week
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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. |
The outcome will be measured at baseline, 4th week and end of 8th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ankle Muscle Strength
Time Frame: Baseline, 4th week and at end of 8th week
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Ankle muscle strength will be evaluated using Hand held dynamometer with the patient in supine lying position.
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Baseline, 4th week and at end of 8th week
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Static Balance
Time Frame: Baseline, 4th week and at the end of 8th week
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Static Balance will be evaluated using Single leg stance test.
The participant will be asked to stand with both feet flat on the floor and hands on their hips or at their sides for balance.
Then the participant will be instructed to shift their weight onto one leg and lift the opposite leg off the ground.
Participants should balance on one leg for as long as possible without touching the ground with the raised leg or using their hands for support.
Timer begins as soon as the participant lifts one leg off the ground and assumes the single leg stance position.
The time each participant was able to maintain balance on each leg will be documented.
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Baseline, 4th week and at the end of 8th week
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Fall Risk
Time Frame: Baseline, 4th week and at the end of the 8th week
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Fall risk will be assess using Timed up and Go test.
In this test participants.The participant will sit in a chair with their feet flat on the floor, and when instructed, they will stand, walk to a line 3 meters away, turn, walk back to the chair, and sit down.
The examiner will start the timer as the participant stands and stop it when they sit back down.
The test will be performed at a normal walking pace, and the examiner will monitor for any difficulty.
The test will be repeated 2-3 times to ensure accuracy, and the best time will be recorded.
A completion time greater than 12 seconds may indicate an increased risk of falls.
If the participant requires assistance, this will be documented.
Results will be interpreted based on the completion time, with a typical healthy performance being less than 10 seconds.
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Baseline, 4th week and at the end of the 8th week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Premavati Lekshmanan, Inti International University
Publications and helpful links
General Publications
- Bittencourt, J. V., Corrêa, L. A., Pagnez, M. A. M., do Rio, J. P. M., Telles, G. F., Mathieson, S., & Nogueira, L. A. C. (2024a). Neural mobilisation effects in nerve function and nerve structure of patients with peripheral neuropathic pain: A systematic review with meta-analysis. PloS One, 19(11), e0313025. https://doi.org/10.1371/journal.pone.0313025
- Basson, A., Olivier, B., Ellis, R., Coppieters, M., Stewart, A., & Mudzi, W. (2017). The effectiveness of neural mobilization for neuromusculoskeletal conditions: A systematic review and meta-Analysis. In Journal of Orthopaedic and Sports Physical Therapy (Vol. 47, Number 9, pp. 593-615). Movement Science Media. https://doi.org/10.2519/jospt.2017.7117
- Baptista, F., Nery, E., Cruz, E., Afreixo, V., & Silva, A. (2023). Effectiveness of Neural Mobilisation on Pain Intensity, Functional Status, and Physical Performance in Adults with Musculoskeletal Pain - A Systematic Review with Meta-Analysis. Clinical Rehabilitation, 38, 145-183. https://doi.org/10.1177/02692155231215216
- Baptista, F. M., Nery, E., Cruz, E. B., Afreixo, V., & Silva, A. G. (2024). Effectiveness of Neural Mobilisation on Pain Intensity, Functional Status, and Physical Performance in Adults with Musculoskeletal Pain - A Systematic Review with Meta-Analysis. Clinical Rehabilitation, 38(2), 145-183. https://doi.org/10.1177/02692155231215216
- Ancillao, A., Palermo, E., & Rossi, S. (2017). Validation of Ankle Strength Measurements by Means of a Hand-Held Dynamometer in Adult Healthy Subjects. Journal of Sensors, 2017. https://doi.org/10.1155/2017/5426031
- Alshami, A. M., Alghamdi, M. A., & Abdelsalam, M. S. (2021). Effect of Neural Mobilization Exercises in Patients With Low Back-Related Leg Pain With Peripheral Nerve Sensitization: A Prospective, Controlled Trial. Journal of Chiropractic Medicine, 20(2), 59-69. https://doi.org/10.1016/j.jcm.2021.07.001
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- INTIIUFHLSRC/BPHTI1NY12025021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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