suffering from lower limb motor impairment secondary to stroke
Conditions
Interventions
Low-intensity Training Group:Low-intensity Training
High-intensity Training Group:High-intensity Training
Sponsors
The First Affiliated Hospital of the University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Compliant with the 2019 edition of "Key Points for the Diagnosis of Various Cerebrovascular Diseases in China" and confirmed by cranial CT or MRI, with stable vital signs; 2. Aged 18–80 years, any gender; 3. First-onset stroke within 2 years; 4. Brunnstrom stage of the affected lower limb is stage III or above; 5. Modified Ashworth Scale for muscle tone of the affected lower limb < grade 2; 6. Able to wear this device; 7. Has certain walking ability and can walk independently indoors for at least 12 meters without using an Ankle Foot Orthosis (AFO) (Functional Ambulation Categories = 3); 8. No significant pain or ataxia; 9. Has not received lower limb orthopedic surgery in the past 6 months, with hip and knee passive range of motion not significantly limited, and ankle passive range of motion maintained in neutral position; 10. Family is informed and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suffering from acute infectious diseases, unstable vital signs, or complicated with severe internal medical conditions such as heart, lung, liver, or kidney diseases; 2. Lower limb skeletal deformities or anatomical abnormalities caused by various reasons, accompanied by other diseases affecting gait, such as lower limb bone and joint injuries or severe osteoporosis; 3. Complicated with lower limb deep vein thrombosis or skin damage or infection at the lower limbs or robot-wearing areas; 4. Vestibular dysfunctions such as benign paroxysmal positional vertigo, cerebellar dysfunction, and other related diseases causing balance disorders; 5. Hearing, vision, or visual field impairments, unilateral neglect, or severe sensory abnormalities; 6. Severe cognitive impairment (MOCA score <= 18) or frequent epilepsy and other diseases preventing cooperation with the experiment; 7. Participation in other drug or medical device clinical trials concurrently.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Walking speed; | — |
Secondary
| Measure | Time frame |
|---|---|
| Balance ability;Activities of Daily Living;Walking endurance;Sit-to-stand ability;Overall functional recovery;Lower limb motor function;Cognitive function;Fatigue;Brain function; | — |
Countries
China
Contacts
Public ContactWu Ming
The First Affiliated Hospital of the University of Science and Technology of China
Outcome results
None listed