JPRN-jRCTs042220066RecruitingPhase 2
Preliminary study on the effectiveness of outpatient rehabilitation treatment combining gait training using the Welwalk and exercise therapy for chronic stroke hemiplegia - PEORTGTWETCSH
Otaka Yohei0 sites12 target enrollmentStarted: September 20, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1. Patients who gave written consent to participate in this study from themselves or their proxy consents
- •2. Patients aged > 18 yo
- •3. Hemiplegic stroke patients eligible for outpatient treatment at the rehabilitation department of Fujita Health University Hospital
- •4. Patients more than 6 months after stroke onset
- •5. Patients who can walk independently or with supervision (regardless of the use of a walking aid)
- •6. Patients whose walking speed is 1.44 km/h or less
- •7. Patients weighing > 35 kg and < 100 kg
- •8. Patients > 140 cm and < 190 cm
Exclusion Criteria
- •1. Patients with a history of epileptic seizures within 3 months
- •2. Patients with symptomatic arrhythmias
- •3.Patients with pacemakers
- •4.Patients with uncontrolled hypertension (resting systolic BP > 180 mm Hg or diastolic BP > 120 mm Hg)
- •5.Patients with uncontrolled tachycardia (resting heart rate > 120 beats/min)
- •6.Patients with susceptible fractures of the legs or spine (such as severe osteoporosis)
- •7.Patients with ectopic ossification of the lower extremities leading to limited range of motion
- •8.Pregnant and possibly pregnant patients
- •9.Patients who have an infection and require isolation
- •10.When practicing wearing robot legs, patients who have difficulty wearing robot legs due to excessive or deformed lower limbs or pressure sores
- •11.Patients participating in intervention studies affecting other lower extremity/trunk movements and gait
- •12.Patients scheduled for antispasticity therapy with botulinum toxin preparations to the lower extremities during the study period
- •13.Patients with a change in walking speed greater than the minimum variable change (0.10 m/s) during the observation period before the start of the intervention
- •14.Other patients judged inappropriate by the attending physician, investigator, subinvestigator, or subinvestigator
Investigators
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