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Not yet recruitingNCT07245602Updated Nov 24, 2025

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

An interventional study of Collaborative Functional Electrical Stimulation and Traditional functional electrical stimulation in Muscle Fatigue (C23.888.592.612.612) and Muscle Weakness or Atrophy, sponsored by Chen Xuan. Not yet recruiting. Open to participants aged 65 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by Chen Xuan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
65 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Muscle Fatigue (C23.888.592.612.612)
  • Muscle Weakness or Atrophy
03

In context

Muscle Weakness

477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.

This study's planned enrollment of 30 is below the median of 44 across 362 interventional studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

This is the only study on the registry with Chen Xuan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study.

Exclusion criteria

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 (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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceCollaborative Functional Electrical Stimulation

    Functional electrical stimulation based on muscle synergy

  • DeviceTraditional functional electrical stimulation

    Traditional functional electrical stimulation

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    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 outcomes

  1. Secondary indicators

    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

    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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2025; primary completion for Nov 2026, 11 months later.

Of 200 non-industry interventional studies with no phase under Muscle Weakness, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 11 months is close to that.

Counting every sponsor, half of 212 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2025
First posted
Nov 24, 2025
StartEst.
Nov 30, 2025
Primary completionEst.
Nov 1, 2026
CompletionEst.
May 1, 2027
Last update
Nov 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07245602
Lead sponsor
Chen Xuan
Responsible party
Chen Xuan (graduate student, Southern Medical University, China) — Sponsor-investigator
First posted
Nov 24, 2025
Start date
Nov 30, 2025 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Nov 24, 2025

Study contacts

Chen Xuan Chen Xuan,Ph.D.
Contact
2415919580@qq.com
+8619731548492
Xuan Chen
study chair · Southern Medical University, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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