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Clinical Trials/JPRN-jRCTs042220128
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.

Registry
who.int
Start Date
January 27, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Yohei Otaka

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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