Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07245602
Enrollment
30
Registered
2025-11-24
Start date
2025-11-30
Completion date
2027-05-01
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Fatigue (C23.888.592.612.612), Muscle Weakness or Atrophy

Brief summary

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

DEVICECollaborative Functional Electrical Stimulation

Functional electrical stimulation based on muscle synergy

DEVICETraditional functional electrical stimulation

Traditional functional electrical stimulation

Sponsors

Chen Xuan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

This study will employ a single-blind (assessor-blinded) design. Participants and Therapists: Due to the distinct nature of the two electrical stimulation interventions, blinding of participants and the therapists administering the treatments is not feasible. However, to minimize expectation bias, all participants will be informed that they will be randomized to one of two effective types of electrical stimulation therapy, without disclosing the specific differences between them. Outcome Assessors: All primary and secondary outcome measures will be collected by an independent assessor who is blinded to the group allocation of the participants. This assessor will not be involved in the intervention process and will be strictly instructed to refrain from discussing any treatment-related information with the participants or therapists throughout the study. Data Analysts: During the data analysis phase, the two groups will be coded as Group A and Group B. The data analyst will per

Eligibility

Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Muscle electrical signalsOn 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.
Important indicators kinematic dataOn 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 againAttach 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

MeasureTime frameDescription
Secondary indicatorsOn 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 yearPlantar 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

Contacts

Primary ContactChen Xuan Chen Xuan,Ph.D.
2415919580@qq.com+8619731548492

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026