JPRN-jRCTs042220128
Recruiting
Phase 3
A study on the effectiveness of gait training using WelWalk on improving gait independence in patients with paraplegia. - EGTWIP
Yohei Otaka0 sites300 target enrollmentJanuary 27, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yohei Otaka
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Individuals who have obtained written consent to participate in this study from the individual or his/her surrogate
- •2\. Individuals who are more than 16 years old
- •3\. Individuals with brain, cerebrovascular, or spinal cord disease
- •4\. Individuals whose weigh range from 35 kg to 100 kg
- •5\. Individuals whose height range from 140 cm to 190 cm
Exclusion Criteria
- •1\. Individuals with uncontrolled hypertension/hypotension
- •2\. Individuals with uncontrolled cardiac or respiratory dysfunction
- •3\. Individuals with a pacemaker device
- •4\. Individuals with lower extremity hemodynamic disturbances that contraindicate exercise therapy
- •5\. Individuals with fracture susceptibility of the lower limbs or spine (e.g., severe osteoporosis)
- •6\. Individuals with heterotopic ossification of the lower extremity leading to joint range of motion limitation
- •7\. Individuals who are pregnant or may be pregnant
- •8\. Individuals with infectious diseases requiring isolation
- •9\. Individuals who are unable to wear the robotic leg due to oversized or deformed lower limbs or pressure ulcers
- •10\. Other individuals who judged inappropriate by the attending physician, investigator, or research assistants
Outcomes
Primary Outcomes
Not specified
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