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Pilot study of gait training with robot in acute hemiplegic patients

Phase 2
Recruiting
Conditions
Stroke
Registration Number
JPRN-jRCTs052180129
Lead Sponsor
Mikami Yasuo
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

1.Primary supratentorial intracerebral hemorrhage or cerebral infarction
2.Within 14 days after onset
3.SIAS lower extremity total score <=6
4.FIM-walk <=3
5.FIM-comprehension >=2
6.FIM-social interaction >=2
7.FIM-memory >=2
8.Patient whose weight is >=40 kg and <95 kg
9.Patient whose height is >=140 cm and <190 cm

Exclusion Criteria

1.History of neuromuscular disease
2.Contracture of lower extremity disturbing walking
3.Participating other studies about function of lower extremity/trunk or walking
4.History of epileptic seizure within 2 years
5.History of myocardial infarction or existence of symptomatic angina, or existence of symptomatic arrhythmia
6.Using pacemaker
7. Uncontrollable hypertension; systemic blood pressure at rest >=180mmHg or diastolic blood pressure at rest <=120mmHg
8.Uncontrollable tachycardia; heart rate at rest >=120bpm
9.Symptomatic pulmonary disease
10.Bone fragility of lower extremities or spine
11.Ectopic ossification of lower extremities causing limitation of range of motion of joints
12.Pregnancy or possibility of pregnancy
13.Patient who required isolation due to infectious diseases
14.Patient who cannot don WW-1000 due to oversize, deformity and swelling of lower extremity
15.When the number of intervention patients exceed the upper limit of each hospital
16.Patient judged unsuitable by the principal investigator or subinvestigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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