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

NCT07245602 | Not Yet Recruiting

• 1 other identifier: 202551
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Muscle electrical signals

  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

  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 Outcomes (1)

• Secondary indicators

  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

Study Arms (2)

Control Arm: Conventional Functional Electrical Stimulation

PLACEBO COMPARATOR

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

Experimental Arm: Muscle Synergy-Based Functional Electrical Stimulation

EXPERIMENTAL

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

Device: Collaborative Functional Electrical Stimulation

Interventions

Collaborative Functional Electrical Stimulation DEVICE

Functional electrical stimulation based on muscle synergy

Experimental Arm: Muscle Synergy-Based Functional Electrical Stimulation

Traditional functional electrical stimulation DEVICE

Traditional functional electrical stimulation

Control Arm: Conventional Functional Electrical Stimulation

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chen Xuan: lead

MeSH Terms

Conditions

Muscle Weakness; Atrophy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• Xuan Chen

  Southern Medical University

  STUDY CHAIR

Central Study Contacts

Chen Xuan Chen Xuan,Ph.D.

CONTACT

+8619731548492; 2415919580@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: graduate student

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: November 24, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share