A randomized controlled clinical study of brain-controlled exoskeleton lower limb robot for the treatment of dysfunction after spinal cord injury

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300074503

Enrollment

Unknown

Registered

2023-08-08

Start date

2023-02-16

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

spinal cord injury

Interventions

Experimental group:Brain-controlled exoskeleton robot + Routine rehabilitation training

Control group:Routine rehabilitation training

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 18-60 years old; Height 155CM-180CM; Weight less than 100Kg; Spinal cord injury confirmed by clinical diagnosis and MR/CT; Muscle tone (modified Ashworth scale)=2; The range of motion of the passive joint of both hip and knee is generally normal, and the ankle joint can be maintained in a neutral position. With informed consent, voluntarily participating in the experiment

Exclusion criteria

Exclusion criteria: The skin in contact with the equipment is broken; The range of joint motion is severely limited, which affects the wearing of exoskeleton; Severe cognitive or visual impairment; Severe convulsions; Active pressure ulcer; Unstable fracture, fracture nonunion; Hip subluxation; Acute deep vein thrombosis; Heterotopic ossification of lower extremity resulted in limited joint motion; Patients with severe osteoporosis; Complicated with craniocerebral injury, ankylosing spondylitis, malignancy, neurodegenerative disease or neuropathy, mental illness, active or progressive infectious disease, unstable angina pectoris, severe arrhythmia and other heart diseases; Pregnant or lactating women; Poor compliance or inability to properly understand the fit to complete the interview

Design outcomes

Primary

Measure	Time frame
American Spinal Injury Association, ASIA ;Spinal Cord Injury Walking Index, WISCI;	—

Secondary

Measure	Time frame
10 meter walk test, 10MWT;6 minute walk test, 6MWT;SCIM-III, Spinal Cord Independence Measure-III;IANR-SCIFRS score;International standards to document remainingautonomic function after spinal cord injury, ISAFSCI score;Modified Ashworth Scale, MAS;Penn score;Quality of life assessment;Geffner, Gonzalez, Santacruz, and Flor, GGSF;Neurogenic Bowel Dysfunction scale, NBDs;Montreal Cognitive Assessment, MoCA;Hospital Anxiety and Depression scale, HADS;VAS;Rating of perceived exertion, RPE;Quebec User Evaluationof Satisfaction with assistive Technology, QUEST;Low frequency oscillation amplitude ALFF analysis;Functional connectivity;VBM;Fractional Anisotropy;Mean Diffusivity;Axial Diffusion;Radial Diffusivity;	—

Measure

Time frame

10 meter walk test, 10MWT;6 minute walk test, 6MWT;SCIM-III, Spinal Cord Independence Measure-III;IANR-SCIFRS score;International standards to document remainingautonomic function after spinal cord injury, ISAFSCI score;Modified Ashworth Scale, MAS;Penn score;Quality of life assessment;Geffner, Gonzalez, Santacruz, and Flor, GGSF;Neurogenic Bowel Dysfunction scale, NBDs;Montreal Cognitive Assessment, MoCA;Hospital Anxiety and Depression scale, HADS;VAS;Rating of perceived exertion, RPE;Quebec User Evaluationof Satisfaction with assistive Technology, QUEST;Low frequency oscillation amplitude ALFF analysis;Functional connectivity;VBM;Fractional Anisotropy;Mean Diffusivity;Axial Diffusion;Radial Diffusivity;

—

Countries

China

Contacts

Public ContactRong Limin

The Third Affiliated Hospital of Sun Yat-sen University

ronglm@mail.sysu.edu.cn+86 136 0978 0973

Outcome results

None listed

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