A Biomechanical Study of Collaborative FES on Lower Limb Motor Function in the Elderly
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-75
SponsorChen Xuan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Collaborative Functional Electrical Stimulation
DeviceFunctional electrical stimulation based on muscle synergy
Traditional functional electrical stimulation
DeviceTraditional functional electrical stimulation
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Control Arm: Conventional Functional Electrical StimulationPlacebo comparator 1 intervention
Group B: Experimental Arm: Muscle Synergy-Based Functional Electrical StimulationExperimental treatment 1 intervention
Trial outcomes
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 againSecondary 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 yearLocations
Sponsors and contacts
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Chen Xuan
Lead sponsor
Southern Medical University, China
Sponsor institution
Source ClinicalTrials.gov
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