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Clinical study of a brain-controlled lower extremity hybrid exoskeleton rehabilitation system

Clinical study of a brain-controlled lower extremity hybrid exoskeleton rehabilitation system

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099071
Enrollment
Unknown
Registered
2025-03-18
Start date
2025-03-24
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with lower limb dysfunction

Interventions

Experimental group (part I):Single system validation experiments:normal walking versus brain-controlled exoskeleton assisted 10-meter walking task
Experimental group (part ?):Routine rehabilitation training+Hybrid exoskeleton robotic system for lower limb therapy
Control group(part ?):Routine rehabilitation training

Sponsors

Tianjin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with lower limb motor dysfunction caused by various diseases, including but not limited to nervous system diseases, musculoskeletal problems, metabolic diseases, etc.; 2. Age 19-80 years old, gender is not limited; 3. Clear consciousness, stable condition and vital signs, MMSE>=27; 4. Have the ability to stand in a static balance; 5. Holden's walking function classification >=2; 6. There was no obvious abnormality in the passive range of motion of the lower limb joints, MAS<=2; 7. Weight less than 100kg, height about 1.5-1.9m; 8. Have not participated in clinical trials of other medical devices or drugs; 9. Agree to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of exoskeleton contraindications such as pressure ulcers at the contact site of the exoskeleton or leg length differences, height/weight restrictions; 2. Contraindications to functional electrical stimulation: such as metal implants, skin diseases, muscle damage, or sensory impairment with reduced or increased sensitivity to electrical stimulation; 3. There are diseases and complications of the locomotor system and circulatory system that affect motor function; 4. There are diseases and complications of the locomotor system and circulatory system that affect motor function.

Design outcomes

Primary

MeasureTime frame
Kinematic data;Electromyography;Electroencephalogram;FMA Lower Extremity Function Scale score;Berg Balance Scale score;Holden Walking Function Scale score;

Secondary

MeasureTime frame
Modified Barthel index scale score;

Countries

China

Contacts

Public ContactLin Meng

Tianjin University

linmeng@tju.edu.cn+86 198 6382 3855

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026