Lower limb exoskeleton robot gait training system (AI intelligent biofeedback neuromuscular reconstruction)

AI smart rehabilitation equipment

National Medical Products Administration Class II/III Medical Device Registration Certificate National Medical Device Registration Approval 20183190226 (AIROBOT); Ministry of Science and Technology National Key R&D Program Intelligent Robot Special · AI Smart Rehabilitation Equipment/National Major Technical Program

Combining aerospace multi-sensor fusion technology, flexible drive algorithms and ergonomic design, China's independently developed lower limb exoskeleton rehabilitation robots (such as Daai Robot and Step Robot) can provide adaptive active/passive assistance based on the patient's residual muscle strength of the lower limbs, and strongly input standard gait neurofeedback during ground walking in simulated real space, subverting the traditional artificial crutch rehabilitation model.

Key clinical breakthroughs benefit

The patient's number of steps in a single training session can reach 8-10 times that of conventional artificial rehabilitation (exceeding 2000 steps each time)

Control group: High recurrence rate / severe trauma

Evidence and recommendation levels

National Medical Products Administration Class II/III Medical Device Registration Certificate National Medical Device Registration Approval 20183190226 (AIROBOT); Ministry of Science and Technology National Key R&D Plan Intelligent Robot Special Project

China Rehabilitation Research Center (Beijing Boai Hospital Intelligent Rehabilitation Center)

Treatment cycle and trauma

2-4 days

Preliminary evaluation of smart sensors for the range of motion of each joint in the pelvis and lower limbs for 1 days; daily exoskeleton adaptive gait training + weight loss support for 15-20 days; three-dimensional gait analysis (Vicon) quantitative comparison after discharge

International comparison of cost-effectiveness

Approximately 60% ~ 85% cost savings

Supports direct payment under international commercial insurance

Mechanism of Action and Technical Advantages

Lower limb exoskeleton robot gait training system core technical principles and clinical paths

1

Training intensity and the number of effective steps per time: The exoskeleton motor accurately drives the hip and knee joints, and the physiological standard gait of 2000-3000 can be completed in a single 45 minute, and the efficiency of brain nerve remodeling is increased 10 times.

2

Gait parameter symmetry correction: Multi-dimensional pressure sensor on the sole of the foot and millisecond-level closed-loop correction of six-axis gyroscope can 100% simulate the physiological gait curve of healthy people and eliminate pathological compensation.

3

The cost of a single course of robot treatment: China’s medical insurance and special medical care are affordable, high-quality and popular, and a full set of high-end gait reshaping treatments with exoskeleton AI only costs ¥10,000 - ¥20,000 (approximately $1,400 - $2,900)

Precise target audience and clinical indications

Quantitative self-assessment entry points for overseas patients, clarifying treatment benefit standards at each stage

Spinal cord injury paraplegia (incomplete/complete SCI), stroke hemiplegia, gait abnormality, multiple sclerosis, Parkinson's disease, frozen gait, and gait correction after major fractures of the lower limbs

Patients who are recovering from stroke or spinal cord injury and whose lower limb muscle strength is at 1-3 level and need high-density gait stimulation; paraplegic patients who are eager to get rid of wheelchairs and experience standing and walking on two legs again; people at high risk of severe osteoporosis and varicose veins of the lower limbs caused by long-term bed rest

Strict Exclusion Criteria and Contraindications

• ✕Those with unhealed fractures of the lower limbs or severe osteoporosis (T value <-4.0) with risk of pathological fractures; those with severe lower limb joint ankylosing contracture and deformity angles exceeding the limit; those with severe orthostatic hypotension and frequent fainting

Registered clinical data versus real-world efficacy

Journal of NeuroEngineering and Rehabilitation: Efficacy of robotic exoskeleton-assisted gait training in subacute stroke: A randomized controlled trial

Key clinical breakthroughs benefit

The patient's number of steps in a single training session can reach 8-10 times that of conventional artificial rehabilitation (exceeding 2000 steps each time)

Disease Control Rate (DCR)

Significant benefits have been gained

Clinical evidence level

National Medical Products Administration Class II/III Medical Device Registration Certificate National Medical Device Registration Approval 20183190226 (AIROBOT); Ministry of Science and Technology National Key R&D Plan Intelligent Robot Special Project

Safety and adverse reaction profile: The patient's number of steps in a single training session can reach 8-10 times that of conventional manual rehabilitation (more than 2000 steps each time); the weight-bearing symmetry index of the lower limbs is improved by 72%, and the upright balance stability of the trunk is significantly enhanced.

Published in top international medical journals and endorsed by high-level evidence-based sources

Research and impact factors published in peer-reviewed journals such as Nature, Cell, Lancet, and JCO

Journal of NeuroEngineering and Rehabilitation5.1

Academic team from the National Medical Center

Journal of NeuroEngineering and Rehabilitation: Efficacy of robotic exoskeleton-assisted gait training in subacute stroke: A randomized controlled trial

Citation: PMID: 33407672; DOI: 10.1186/s12984-020-00803-2 (IF: 5.1)

PubMed authoritative searchDOI original text

Frontiers in Neuroscience4.3

Academic team from the National Medical Center

Frontiers in Neuroscience: Brain functional network reorganization following exoskeleton robotic gait training in spinal cord injury

Citation: PMID: 34512268; DOI: 10.3389/fnins.2021.724519 (IF: 4.3)

PubMed authoritative searchDOI original text

Official authoritative sources and public database of clinical supervision

Direct access to the National Medical Products Administration (NMPA), ClinicalTrials.gov, PubMed, and academic guidelines for public verification

PMID: 33407672; DOI: 10.1186/s12984-020-00803-2 (IF: 5.1)

Journal of NeuroEngineering and Rehabilitation: Efficacy of robotic exoskeleton-assisted gait training in subacute stroke: A randomized controlled trial

PMID: 34512268; DOI: 10.3389/fnins.2021.724519 (IF: 4.3)

Frontiers in Neuroscience: Brain functional network reorganization following exoskeleton robotic gait training in spinal cord injury

National Drug Administration Approval [2020] No. 45

National Medical Products Administration: Guiding Principles for Technical Review of Lower Limb Exoskeleton Walking Rehabilitation Devices

Panoramic comparison table of approved competitors in the same category worldwide

Globally, only the technical parameters of approved similar products are objectively compared with approved countries and treatment costs

Technology / Procedure / Device Name	Research and development institutions	Mechanism Principle / Platform Type	Main clinical indications	Approved regions and years	International reference fees
Lower limb exoskeleton robot gait training systemThis plan	China's top specialized medical center	Training intensity and number of effective steps per session	The exoskeleton motor accurately drives the hip and knee joints. It can complete the physiological standard gait of 2000-3000 in a single 45 minute, and the efficiency of brain nerve remodeling is increased 10 times.	Clinical centers in China and internationally2024-2026	¥10,000 - ¥20,000 (approximately $1,400 - $2,900, based on the standard 20 high-frequency robot intelligent gait training cycle)
Lower limb exoskeleton robot gait training system	China's top specialized medical center	Gait parameter symmetry correction	The multi-dimensional pressure sensor on the sole of the foot combined with the six-axis gyroscope millisecond-level closed-loop correction can 100% simulate the physiological gait curve of healthy people and eliminate pathological compensation.	Clinical centers in China and internationally2024-2026	¥10,000 - ¥20,000 (approximately $1,400 - $2,900, based on the standard 20 high-frequency robot intelligent gait training cycle)
Lower limb exoskeleton robot gait training system	China's top specialized medical center	Robot single treatment cost	China's medical insurance and special medical care are affordable, high-quality and widely available. A complete set of high-end gait reconstruction treatments with exoskeleton AI only costs ¥10,000 - ¥20,000 (approximately $1,400 - $2,900)	Clinical centers in China and internationally2024-2026	¥10,000 - ¥20,000 (approximately $1,400 - $2,900, based on the standard 20 high-frequency robot intelligent gait training cycle)

Real-world typical cases and treatment outcomes

Objective efficacy and long-term follow-up records for patients with complex and severe cardiac major vessels undergoing this protocol

Baseline patient profile

A 28-year-old male suffered an incomplete spinal cord injury to the 10 segments of his chest due to a car accident (ASIA grade C). His muscle strength in both lower limbs was only 1-2. He was severely weak in both lower limbs and unable to stand independently. He had been in a wheelchair for more than 4 months. He was accompanied by mild disuse atrophy of the muscles in both lower limbs, and his mental state was severe anxiety and despair.

Significant clinical remission and functional reconstruction

Previous treatment history and treatment challenges:

The patient desperately desires to stand and walk again, but in conventional rehabilitation institutions he can only do turning over on the bed and sitting balance exercises, and cannot move his legs.

Specific implementation path of this plan:

After entering the smart rehabilitation center, the patient was evaluated for spinal fixation and good callus healing. The team customized the "AI lower limb exoskeleton robot high-frequency enhanced gait program" for him, training 5 times a week, and performing 45 minutes of robot-assisted weight loss field walking each time, monitoring the symmetrical distribution of plantar pressure in real time.

Objective efficacy and outcome records:

After wearing the robot while standing and walking for the first time, he completed 1,200 steps, and the patient regained confidence in walking with his legs. After 4 weeks of continuous training (with a total of more than 45,000 steps taken), the central nervous system feedback stimulated significant residual movement conduction, and the key muscle strength of both lower limbs was significantly improved from level 1-2 to level 3-4. When discharged from the hospital on the 30th day of treatment, the patient was able to wean off the exoskeleton and walk independently and continuously for 150 meters with the slight assistance of an ordinary four-legged cane.

Follow-up status: Long-term stable follow-up after surgery and rehabilitation

Officially undertook tertiary A hospital

National Rehabilitation Medical Research Hub / The Birthplace of Modern Rehabilitation Medicine in China

China Rehabilitation Research Center (Beijing Boai Hospital Intelligent Rehabilitation Center)

National Rehabilitation Medical Research Hub / The Birthplace of Modern Rehabilitation Medicine in China

Professor Mi Zhongxiang / Professor You Chunjing

Fudan ranks second in the country in comprehensive specialty rankings / Intelligent Human-Computer Interaction Rehabilitation Demonstration Center

West China Hospital of Sichuan University (Rehabilitation Medicine Center)

Fudan ranks second in the country in comprehensive specialty rankings / Intelligent Human-Computer Interaction Rehabilitation Demonstration Center

Professor He Chengqi / Professor Gao Qiang

National Medical Center for Neurological Diseases/National Key Discipline

Huashan Hospital Affiliated to Fudan University (Department of Rehabilitation Medicine)

National Medical Center for Neurological Diseases/National Key Discipline

Professor Wu Yi, Professor Jia Jie Neuro-intelligent Rehabilitation Team

List of necessary medical records before travel:

•Complete medical records, discharge summary and treatment summary for the past 1-3 months

•High-resolution DICOM format image master (CT / MRI / DSA / PET-CT)

•Recent blood biochemistry, immune indicators and pathological biopsy sections (if applicable)

•Previous surgical records and key medication details