TCTR20231031005
Completed
Phase 4
Effects of Wearable Exoskeleton Robotic Gait Training in Subacute Stroke: A Pilot Randomized Controlled Trial
Viktas Aeternum Co., Ltd0 sites28 target enrollmentOctober 31, 2023
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hemiplegic subacute stroke patient (between 2 weeks and 6 months) who are not able to walk independently
- Sponsor
- Viktas Aeternum Co., Ltd
- Enrollment
- 28
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patient aged 18 years or old
- •2\.First confirmed diagnosis of stroke through radiographs
- •3\.Hemiplegia
- •4\.Stroke occurred between 2 weeks and 6 months
- •5\.Functional Ambulation Categories ranging from 0 to 2
- •6\.Capable of independently deciding to participate in the study and able to follow instructions during assessment and gait training, as well as participate in controlling the wearable exoskeleton with the physiotherapist
Exclusion Criteria
- •1\.Patients with unstable vital signs or neurological symptoms
- •2\.Patients with medical diseases that may cause harm/adverse outcomes, such as uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 100 mmHg), orthostatic hypotension, myocardial ischemia/heart failure in the last three months, respiratory disorders (such as chronic obstructive pulmonary disease and asthma), severe osteoporosis that increases the fractures risk from falling while walking and standing
- •3\.Patients with neurological disorders, such as Parkinson disease, dementia, and multiple sclerosis
- •4\.Patients with severe communication and cognitive impairment that prevent them from following instructions or participating in the training
- •5\.Patients with dermatitis or open wounds on the torso or lower limb
- •6\.Patients with lower limb length discrepancy greater than 2 cm
- •7\.Patients with a Modified Ashworth Scale of lower limb \>\= 3
- •8\.Patients with a limited range of motion in the lower limb that prevents them from changing from sitting to standing or stepping from standing with wearable exoskeleton robotic gait training
Outcomes
Primary Outcomes
Not specified
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