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NCT Number: NCT07245602

A Biomechanical Study of Collaborative FES on Lower Limb Motor Function in the Elderly

This study will first conduct a precise assessment of the differences in muscle coordination among the elderly through muscle synergy analysis; then, based on this, it will extract abnormal synergy patterns and muscle activation patterns, and reconstruct the intervention's synergy modules to fit the intervention electrostimulation curve; finally, electrical stimulation interventions will be carried out on different elderly individuals under two conditions: sitting and walking, to evaluate the intervention effects and analyze the biomechanical mechanisms of its effectiveness.

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Key information

About this study

The research subjects of this project mainly focus on young people, middle-aged individuals, and elderly individuals who are able to move independently. The investigator's goal is to explore the kinematic and dynamic characteristics of different populations. The main research activities include recruiting young volunteers, middle-aged volunteers, and elderly volunteers who can move independently. Through motion capture, the kinematic data and surface electromyography (sEMG) signal confidence intervals of young and middle-aged subjects are analyzed, and then the kinematic data and sEMG data of independently mobile elderly individuals are examined. The investigator aims to identify multiple muscles that show significant differences compared to normal individuals, and then assess the effectiveness of functional electrical stimulation based on coordinated movement. Additionally, using in vivo motion technology, the investigator will establish a human biomechanics database to analyze the biomechanical characteristics of different populations under various movement conditions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be aged between 65 and 75 years, inclusive.
  • Must be community-dwelling.
  • Must be able to ambulate independently, with or without the use of an assistive device (e.g., a cane or walker).
  • Must be capable of understanding and following study-related instructions and procedures.
  • Must provide voluntary written informed consent to participate in the study.

Exclusion criteria

  • Diagnosis of a significant neurological disorder, including but not limited to stroke, Parkinson's disease, or multiple sclerosis.
  • Presence of a severe musculoskeletal condition that would interfere with movement tasks, such as severe osteoarthritis or osteoporosis.
  • History of lower limb joint replacement surgery within the last 6 months.
  • Cognitive impairment, as indicated by a Mini-Mental State Examination (MMSE) score of less than 24.
  • Presence of any implanted electronic medical device, such as a cardiac pacemaker or defibrillator.
  • Any skin disease, open wound, infection, or malignancy at the intended sites of electrical stimulation.
  • Diagnosis of a severe and/or uncontrolled cardiovascular condition (e.g., unstable angina, recent myocardial infarction).
  • Inability to stand independently without support for at least 3 minutes.

Treatment and study plan

Collaborative Functional Electrical Stimulation

Device

Functional electrical stimulation based on muscle synergy

Traditional functional electrical stimulation

Device

Traditional functional electrical stimulation

Primary outcomes

  1. Muscle electrical signals

    Time frame: On the first day of the study, muscle electrical signals were tested using electromyography equipment. After one month of intervention, these indicators were measured again, followed by a one-year follow-up with the participants until the study ended.

    Electromyographic signals were collected from 16 muscles of the trunk and ipsilateral leg using a wireless EMG system (Mini Wave Infinity by Cometa, Italy) at a frequency of 2000 Hz, with an interelectrode distance of 20 mm.

  2. Important indicators kinematic data

    Time frame: On the first day of the study, kinematic data, including joint angles and stride length, were collected using the Qualisys gait analysis system. After one month of intervention, these measurements were taken again

    Attach Mark points to the subjects and capture kinematic data through an infrared camera.The movement of the foot and lower limb joints was captured using eight optical infrared cameras (also sampled at 100 Hz; Miqus M1, Qualisys, Sweden) and one camera lens (Miqus Video, Qualisys, Sweden), calculating the positions of 56 optical markers.

Secondary outcomes

  1. Secondary indicators

    Time frame: On the first day of the study, foot pressure was measured using a plantar pressure testing mat, followed by a one-month intervention, after which the same indicators were measured again. Subsequently, the subjects were followed up for one year

    Plantar pressure, distribution of plantar pressure on the left and right feet at rest, and distribution of pressure intensity on the left and right feet while walking

Study contacts

Contact information is provided by the study sponsor or research team.

Chen Xuan Chen Xuan,Ph.D.

CONTACT

[email protected]

+8619731548492

Sponsors and collaborators

Lead sponsor

Chen Xuan

Other

Registry information

Official study title

Biomechanical Study on the Improvement of Lower Limb Motor Function in the Elderly Through Collaborative Functional Electrical Stimulation

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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