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

Chen Xuan

Status: Not yet enrolling

Conditions: Muscle Fatigue (C23.888.592.612.612); Muscle Weakness or Atrophy

Treatments: Device: Collaborative Functional Electrical Stimulation; Device: Traditional functional electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07245602

202551

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 65 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Control Arm: Conventional Functional Electrical Stimulation

Placebo Comparator group

Description:

Participants will receive functional electrical stimulation (FES) administered in a conventional, non-synergy-based mode. This arm serves as an active comparator.

Treatment:

Device: Traditional functional electrical stimulation

Experimental Arm: Muscle Synergy-Based Functional Electrical Stimulation

Experimental group

Description:

Participants will receive a novel functional electrical stimulation (FES) intervention guided by a real-time, muscle synergy-based algorithm.

Treatment:

Device: Collaborative Functional Electrical Stimulation