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

November 17, 2025 updated by: Chen Xuan

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chen Xuan Chen Xuan,Ph.D.
  • Phone Number: +8619731548492
  • Email: 2415919580@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Arm: Conventional Functional Electrical Stimulation
Participants will receive functional electrical stimulation (FES) administered in a conventional, non-synergy-based mode. This arm serves as an active comparator.
Device: Traditional functional electrical stimulation
Traditional functional electrical stimulation
Experimental: Experimental Arm: Muscle Synergy-Based Functional Electrical Stimulation
Participants will receive a novel functional electrical stimulation (FES) intervention guided by a real-time, muscle synergy-based algorithm.
Device: Collaborative Functional Electrical Stimulation
Functional electrical stimulation based on muscle synergy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chen Xuan

Investigators

  • Study Chair: Xuan Chen, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

September 25, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202551

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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