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Clinical Trials/JPRN-jRCT1032210357
JPRN-jRCT1032210357RecruitingPhase 2

Effects of ankle joint motion training using a lower limb exoskeleton robot among hemiplegic patients with stroke

Michiyuki Kawakami0 sites50 target enrollmentStarted: October 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
50

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 18age old to ot applicable (—)
Sex
All

Inclusion Criteria

  • Stroke patients
  • Hemiplegia due to unilateral cerebral hemisphere lesion
  • Age: 18 years and older
  • Lower limb motor impairment, SIAS(foot pat) 1 or greater
  • Ankle dorsiflexion range of motion is 0 degrees or greater.
  • Patients who do not have severe aphasia or cognitive impairment and can understand the purpose of the study.
  • Patients with no contraindication to exercise therapy.

Exclusion Criteria

  • Examples of contraindications to exercise therapy (details are given below)
  • 1) Serious cardiac disease: unstable angina, myocardial infarction of short duration, non-compensated congestive heart failure, acute pulmonary heart, uncontrolled arrhythmia, severe aortic stenosis, active myocarditis, endocarditis, etc.
  • 2) Poorly controlled hypertension
  • (iii) Acute systemic illness or fever
  • (iv) Recent pulmonary embolism, acute pulmonary heart, severe pulmonary hypertension
  • 5) Complication of severe hepatic or renal dysfunction
  • (6) Complication of severe orthopedic disease that interferes with lower limb movement
  • 7) Severe cognitive impairment, severe psychiatric disease
  • (viii) Other metabolic disorders (e.g., acute thyroiditis)
  • (9) Patients with spontaneous pain or inflammation of the ankle joint
  • Patients with a history of ankle fracture or traumatic tendon injury.
  • Patients with contractures of the ankle joint
  • Patients with impaired consciousness
  • (9) Patients for whom written consent could not be obtained

Investigators

Sponsor
Michiyuki Kawakami

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