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Clinical Trials/JPRN-jRCTs042230126
JPRN-jRCTs042230126
Recruiting
Phase 2

Effectiveness study in robot-assisted gait training using R325FS for individuals with subacute hemiparetic stroke - RAGT using R325FS study

Otaka Yohei0 sites50 target enrollmentJanuary 11, 2024
ConditionsStroke

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stroke
Sponsor
Otaka Yohei
Enrollment
50
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 11, 2024
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Otaka Yohei

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 over 16 years old
  • 3\. Individuals with hemiparetic stroke within 180 days of stroke onset
  • 4\. Individuals who scored 2 or more on FIM comprehension, social interaction, problem solving, and memory
  • 5\. Individuals whose weight is between 35 kg and 100 kg
  • 6\. Individuals whose height is between 140 cm and 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 for any reason
  • 10\. Other individuals who are deemed inappropriate by the attending physician, principal investigator, or research assistants

Outcomes

Primary Outcomes

Not specified

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