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Effects of MI-BCI-upper limb exoskeleton rehabilitation training on the improvement of motor function, cognitive function and ADL ability in patients with spinal cord injury based on fNIRS

Effects of MI-BCI-upper limb exoskeleton rehabilitation training on the improvement of motor function, cognitive function and ADL ability in patients with spinal cord injury based on fNIRS

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087597
Enrollment
Unknown
Registered
2024-07-31
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

Spinal cord injury

Interventions

SCI control group:Routine occupational therapy training
SCI upper limb exoskeleton group:upper limb exoskeleton rehabilitation training
SCI MI- BCI upper limb exoskeleton group:MI- BCI upper limb exoskeleton rehabilitation training

Sponsors

China Rehabilitation Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: patient (1) Meet the diagnostic criteria for spinal cord injury and have a traumatic or non-progressive medical cause; (2) Loss of motor and sensory functions of the upper limbs below the injury plane (upper arm, forearm); (3) First onset, regardless of gender, course of disease 2 weeks to 6 months, the condition is stable, no aggravation or progressive change; (4) Between the ages of 18 and 65, right-handed; (5) Clear awareness, good understanding, patients can understand and cooperate with treatment and evaluation; (6) Modified Ashworth scale grade of upper limb =2; (7) Able to remain seated for =30 minutes; (8) Have certain motor imagination ability: motor and visual imagination questionnaire (KVIQ)=55; (9) No visual impairment, international standard eye chart check binocular vision or corrected vision =1.0; (10) Have not participated in other clinical studies in the past 3 months; (11) Patients or their family members agree to participate in this experiment and sign informed consent. Healthy person (1) Good health, no circulatory systemnervous systemmental and metabolic disorders and other diseases; (2) Between the ages of 18 and 65; (3) Clear awareness, good understanding, patients can understand and cooperate with treatment and evaluation; (4) Be able to remain seated for =30 minutes; (5) Have certain motor imagination ability: motor and visual imagination questionnaire (KVIQ)=55 ; (6) No visual impairment, international standard eye chart check binocular vision or corrected vision =1.0; (7) Having full capacity for civil conduct; (8) The subject agrees to participate in the experiment and signs the informed consent.

Exclusion criteria

Exclusion criteria: patient (1) Patients who are using drugs that affect the central nervous system or receiving other neuroregulatory treatments; (2) Serious complications, cardiopulmonary diseases, uncontrolled hypertension, severe physical deformities, multiple organ injuries or major organ dysfunction, severe spasms, etc.; (3) Suffering from other musculoskeletal and other neurological diseases that affect the motor function of the upper limb and affect the rehabilitation process, such as upper limb fractures, severe arthritis, joint replacement, etc.; (4) Have severe cognitive impairment, MMSE score <21, have hearing impairment, visual impairment, aphasia and other difficulties to cooperate with training; (5) A history of epilepsy or mental illness; (6) Drug or chronic alcohol addiction; (7) Intracranial metal objects, intracranial tumors, intracranial infections, or the presence of any clinically significant or unstable medical diseases; (8) Infection; (9) Contraindications of brain-computer interface and/or upper limb exoskeleton rehabilitation system (skin collapse at the contact site, etc.); (10) Contraindications for the use of fNIRS equipment (head defects or abnormalities, etc.); (11) Concurrent participation in other clinical research trials focusing on specific unconventional treatments for upper limb function. Healthy people: (1) Previous history of atrial fibrillation, heart surgery or betaloc; (2) Historys of mental illness, drug abuse, or drug dependence; (3) Pregnancy test positive or breastfeeding women; (4) Excessive consumption (more than 8 cups per day, 250mL per cup) of tea, coffee or caffeinated beverages in the past 6 months; Had consumed any beverage or food containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the trial began; (6) Drug or chronic alcohol addiction; (7) Intracranial metal objects, intracranial tumors, intracranial infections, or the presence of any clinically significant or unstable medical diseases; (8) Infection; (9) Defective or abnormal head, unable to collect fNIRS data.

Design outcomes

Primary

MeasureTime frame
upper extremity motor score;Montreal cognitive assessment;action research arm test;spinal cord independence measure III;

Secondary

MeasureTime frame
muscle thickness;hand grip force;modified ashworth scale;muscular tension;upper extremity sensory score;digital span test;symbol digit modalities test;Rey-Osterrieth complex figure test;Stroop color-word test;capabolities of upper extremity questionnaire;Self-rating Depression Scale;Self-rating Anxiety Scale;Hamilton Anxiety Scale;Hamilton Depression Scale;spinal cord injury of dysfunction quality of life rating scale;kinesthetic and visual imagery questionnaire-20;fNIRS relevant data ;

Countries

China

Contacts

Public ContactLiang Xing

China Rehabilitation Research Center

13671238842@163.com+86 136 7123 8842

Outcome results

None listed

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