Muscle Fatigue (C23.888.592.612.612)NCT07245602
A Biomechanical Study of Collaborative FES on Lower Limb Motor Function in the Elderly
A study testing Collaborative Functional Electrical Stimulation and Traditional functional electrical stimulation in people with Muscle Fatigue (C23.888.592.612.612) and Muscle Weakness or Atrophy, run by Chen Xuan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Muscle Fatigue (C23.888.592.612.612), Muscle Weakness or Atrophy
- What is being tested?
- Collaborative Functional Electrical Stimulation and Traditional functional electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biomechanical Study on the Improvement of Lower Limb Motor Function in the Elderly Through Collaborative Functional Electrical Stimulation
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.
- Being tested
- Collaborative Functional Electrical Stimulation, Traditional functional electrical stimulation
- Medical subject headings
- Muscle Weakness, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Functional Electrical StimulationDevice
Functional electrical stimulation based on muscle synergy
Traditional functional electrical stimulationDevice
Traditional functional electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Collaborative Functional Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Fatigue (C23.888.592.612.612)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Xuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Xuan, Southern Medical University, China
- Investigators
- Xuan Chen, Study chair, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245602
- Sponsor's protocol ID
- 202551
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Study on the Improvement of Lower Limb Motor Function in the Elderly Through Collaborative Functional Electrical Stimulation
- ClinicalTrials.gov ID
- NCT07245602
- Acronym / sponsor ID
- 202551
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chen XuanUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm: Conventional Functional Electrical Stimulation | Placebo comparator | Device: Traditional functional electrical stimulationParticipants will receive functional electrical stimulation (FES) administered in a conventional, non-synergy-based mode. This arm serves as an active comparator. |
| Experimental Arm: Muscle Synergy-Based Functional Electrical Stimulation | Experimental | Device: Collaborative Functional Electrical StimulationParticipants will receive a novel functional electrical stimulation (FES) intervention guided by a real-time, muscle synergy-based algorithm. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Functional Electrical StimulationFunctional electrical stimulation based on muscle synergy | Device | Experimental Arm: Muscle Synergy-Based Functional Electrical Stimulation |
| Traditional functional electrical stimulationTraditional functional electrical stimulation | Device | Control Arm: Conventional Functional Electrical Stimulation |
Primary outcome
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.
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 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
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xuan Chen study chair
Southern Medical University, China
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Functional Electrical Stimulation and Traditional functional electrical stimulation in people with Muscle Fatigue (C23.888.592.612.612) and Muscle Weakness or Atrophy, run by Chen Xuan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Xuan Chen Xuan,Ph.D. (+8619731548492, 2415919580@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.