Impact of Lower Limb Neural Mobilization on Neuromuscular Function and Calf Muscle Thickness in Elderly Individuals With Sarcopenia

NCT07515144 | Enrolling By Invitation

• 1 other identifier: INTIIUFHLSRC/BPHTI1NY12025021
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopneia in Elderly Individuals

Outcome Measures

Primary Outcomes (1)

• Calf Muscle Thickness

  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

Secondary Outcomes (3)

• 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

Study Arms (2)

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

Other: Neural Mobilization; Other: Otago Exercise

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.

Other: Otago Exercise

Interventions

Neural Mobilization OTHER

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.

Neural Mobilization and Otago Exercise Group

Otago Exercise OTHER

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 and Otago Exercise Group; Otago exercise Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sarcopenia is diagnosed according to the criteria established by the European Working Group on Sarcopenia in Older People (EWGSOP).

You may not qualify if:

• 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.

Sponsors & Collaborators

• INTI International University: lead

Study Sites (1)

Mercy Convalescent & Nursing Home

Seremban, Negeri Sembilan, 70100, Malaysia

Location

Related Publications (6)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

Study Officials

• Premavati Lekshmanan

  INTI International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: Participants will be randomly assigned to two parallel groups. The experimental group will receive lower limb neural mobilization in combination with the Otago Exercise Program, while the control group will receive the Otago Exercise Program alone. Both groups will undergo their respective interventions concurrently over the study period, and outcomes including static balance, fall risk, ankle muscle strength, and calf muscle thickness will be assessed before and after the intervention.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: November 4, 2025
• Primary Completion: April 5, 2026
• Study Completion (Estimated): May 24, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)