Pilot study of gait training with robot in acute hemiplegic patients

JRCT ID: jRCTs052180129

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 16/07/2019
• Target sample size: 40
• Countries of recruitment: None.,Japan
• Study type: Interventional
• Intervention(s): Participants are divided into two groups at an acute hospital; group A performing gait training with orthosis or group B performing gait training with robot. Participants perform gait training with orthosis or robot, 40 minutes a day, 5 days a week, in addition to physical therapy, occupational therapy, or speech therapy at the acute hospital. At the rehabilitation hospital, participants perform gait training with robot, 40 minutes a day, 7 days a week, in addition to physical therapy, occupational therapy, or speech therapy.

Outcome(s)

• Primary Outcome: Improvement efficiency for gait independece

Secondary Outcome

1.Functional Independence Measure (FIM)
2.Stroke Impairment Assessment Set (SIAS)
3.Walking performance
4.Dose of gait exercise
5.Length of stay
6.Time after onset at the discharge

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

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

Exclude 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.

Related Information

• Primary Sponsor: Mikami Yasuo
• Source(s) of Monetary Support: Toyota Motor Corporation