Stroke
Conditions
Interventions
Conventional Group:Conventional rehabilitation therapy combined with routine gait training
Lower limb robot group:Conventional rehabilitation therapy combined with lower limb robot training
Sponsors
The First Rehabilitation Hospital of Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Unilateral hemiplegia resulting from a first-ever clinically confirmed stroke, with a post-stroke duration of more than 2 weeks; 2.Aged between 18 and 80 years; 3.Body weight < 100 kg, height between 140 and 200 cm; 4.Normal gait function prior to the first stroke episode; 5.Ability to comprehend and follow simple instructions; 6.Willingness to participate and provision of signed informed consent for this clinical study.
Exclusion criteria
Exclusion criteria: 1. Unstable basic vital signs; 2. Lower limb bone or joint tumors, deformities, or amputation; 3. Severe spinal deformity; 4. Severe osteoporosis; 5. New York Heart Association (NYHA) class III or higher cardiac function; 6. Restricted range of motion in lower limb joints or deep vein thrombosis (DVT) in the lower limbs; 7. Severe musculoskeletal disorders affecting lower limb motor function (e.g., severe persistent joint stiffness); 8. Lower limb fractures that have not met clinical healing criteria; 9. Severe lower limb spasticity (Modified Ashworth Scale >= grade 3).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fNIRS optical imaging indicators: oxyhemoglobin (OxHb) concentration, laterality index (LI);Functional near-infrared spectroscopy;Gait assessment indicator;Balance indicator;Fugl-Meyer Scale scores;10 Meter Walk Test scores;Berg’s Balance Scale scores;Trunk Impairment Scale Indicators;Measures of Activity and Participation based on the ICF; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional Ambulation Category scores;6 Minute Walk Test scores;Simplified Mental State;Balance function evaluation (Fugl Meyer evaluation method) indicators;Tinetti Gait and Balance Scale Indicators;Holden walking function grading Indicators;Parameters of the Timed Up and Go (TUG) Test;3-Meter Timed Up and Go Test under Dual-Task Conditions;Parameters of the Functional Reach Test;Parameters of the Multi-Directional Reach Test;Scores on the Montreal Cognitive Assessment;Modified Barthel Index;Hamilton Depression Rating Scale (HAMD) Scores;Hamilton Anxiety Rating Scale (HAMA) Scores;Instrumental Activities of Daily Living (IADL) Scale Scores; | — |
Countries
China
Contacts
Public ContactWu Xuejiao
The First Rehabilitation Hospital of Shanghai
Outcome results
None listed