A Study on the Effectiveness Evaluation in Stroke Patients Using Lower Limb Assistive Walking Devices
- Conditions
- Stroke
- Registration Number
- NCT06564480
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Patients diagnosed with stroke through CT or MRI, and only accompanied by hemiplegia<br> on one side, with first-time onset or previous episodes without residual<br> neurological dysfunction;<br><br> - Vital signs stable, neurological symptoms no longer aggravate after 48 hours, no<br> severe cognitive impairment or aphasia, and cooperate with training;<br><br> - Modified Ashworth score for lower limb = level 2, standing balance function level<br> =1;<br><br> - Voluntarily participating in this trial, understanding and cooperating with the<br> entire trial process, and signing a written informed consent form.<br><br>Exclusion Criteria:<br><br> - Bone, joint, muscle disease, or lower limb disabilities (such as severe<br> osteoporosis, fractures, spinal instability, severely limited joint range of motion,<br> severe limb muscle contractures, deformities, etc.) or diseases that affect balance<br> and walking;<br><br> - Stroke caused by cerebellar brainstem injury and cortical injury;<br><br> - Patients with severe primary diseases such as cardiovascular, pulmonary, hepatic,<br> renal, and hematopoietic systems, as well as critically ill and psychiatric<br> patients;<br><br> - Other contraindications or complications that may affect walking training treatment;<br><br> - Patients with local skin damage or pressure ulcers in the lower limbs;<br><br> - Patients with peripheral nerve injury in the lower limbs;<br><br> - Inappropriate body shape for robots (height<150cm or>190cm, or weight>85 kg);<br><br> - Planned pregnancy or pregnant and lactating women;<br><br> - Participants in other clinical trials within the past 3 months;<br><br> - Severe cognitive impairment;<br><br> - Known refusal or inability to comply with protocol requirements for any reason<br> (including planned clinical visits and examinations);<br><br> - The researchers believe that it should not participate in this clinical trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fugl Meyer Lower Limb Balance Assessment Scale Score on the 28th day
- Secondary Outcome Measures
Name Time Method Fugl Meyer Lower Limb Balance Assessment Scale Score on the 0th and 14th day;Holden Walking Function Classification;Modified Barthel Index