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

Official title

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

Overview

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.

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.

Interventions

• Device Collaborative Functional Electrical Stimulation
  Functional electrical stimulation based on muscle synergy
• Device Traditional functional electrical stimulation
  Traditional functional electrical stimulation

Primary outcome measures

• 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.]
• 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]

Secondary outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07245602 · 202551

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗