Stroke
Conditions
Interventions
Robot Group:Adding the REX rehabilitation robot to conventional rehabilitation treatment
Control Group:Adding routine balance and lower extremity functional training to conventional rehabilitation treatment
Sponsors
Shanghai Hebin Rehabilitation Hospital(Rehabilitation Sub-center of Huashan Hospital , Fudan University)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1: Patients with unilateral hemiparesis after stroke, in accordance with the diagnostic criteria for various cerebrovascular diseases revised at the 2019 National Cerebrovascular Disease Academic Conference of the Chinese Medical Association, all have imaging diagnosis based on head CT or MRI. 2: Patients with first-onset subcortical stroke, including ischemic and hemorrhagic strokes, within a duration of 2 weeks to 6 months. 3: Age between 18 and 85 years old. 4: Brunnstrom stage =4 for lower limb hemiparesis. 5: Muscle tone of lower limbs =2. 6: Berg Balance Scale (BBS) score =20. 7: The patient is unable to walk independently and requires assistance from a therapist. Assistance can be provided by one to two individuals at varying degrees (ranging from minimal to maximal assistance or complete dependence). 8: Stable vital signs and stable condition of the disease. 9: No significant cognitive impairment and able to understand training content (MMSE score >24).
Exclusion criteria
Exclusion criteria: 1: Severe arthritis or other serious musculoskeletal diseases. 2: Severe limitation of joint mobility, which restricts the movement of the robot. 3: Presence of severe osteoporosis as indicated by bone density tests. 4: Skin damage or infection in the area where the robot is worn. 5: Inability to participate in physical activity due to comorbidities such as orthostatic hypotension, deep vein thrombosis in lower limbs, unstable hypertension, or severe cardiovascular or pulmonary diseases. 6: Significant impairments in speech, attention, hearing, vision (hemineglect, hemianopia), intelligence, mental health or cognitive function. 7: History of organic brain disease, neurological and psychiatric disorders, substance abuse or alcoholism. 8: Severe organ failure in vital organs such as heart, lungs liver and kidneys. 9: Presence of significant pain (VAS > 4) in the body. 10: Presence of internal metallic objects such as cardiac pacemakers and metal stents. 11: Claustrophobia or other contraindications for magnetic resonance imaging examination. 12:Presence of cranial defects or previous cranial repairs. 13:Inability to cooperate with treatment and evaluation tasks,or poor compliance from patients. 14:Participation in other concurrent clinical trials. 15:Other situations deemed unsuitable for inclusion by researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Berg Balance Function Assessment Scale;functional near-infrared spectroscopy,fNIRS;Multimodal functional magnetic resonance lmaging scanning; | — |
Secondary
| Measure | Time frame |
|---|---|
| functional ambulation category scale;Fugl-Meyer Motor Function Rating Scale;Postural Assessment Scale for Stroke Patients (PASS);Spasticity rating (modified Ashworth method);Modified Barthel scores;Montreal Cognitive Assessment;Grip strength assessment;Tecnobody Balance Test;Plantar Pressure Analysis System; | — |
Countries
CHINA
Contacts
Public ContactYanzheng Zhang
Shanghai Hebin Rehabilitation Hospital(Rehabilitation Sub-center of Huashan Hospital , Fudan University)
Outcome results
None listed