NIPH Clinical Trials Search

JRCT ID: jRCTs072180071

Registered date:20/03/2019

Clinical application of Gait Exercise Assist Robot to one leg paralysis patients

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedone leg paralysis
Date of first enrollment06/04/2015
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)Evaluate the effectiveness of walking exercise using Gait Exercise Assist Robot for patients with lower limb paralysis due to stroke / brain tumor, compared with conventional walking exercises using lower limb orthosis.


Primary Outcome1. Functional Independence Measure (FIM) 2. 10m walking time 3. Step count of 10m walking 4. Gait (two action/three action, front type/alignment type/back type) 5. Stroke Impairment Assessment Set 6. Brunnstrom Stage 7. 3D motion analysis, surface electromyogram measurement 8. Walking video (frontal plane, sagittal plane) 9. Walking independence degree on a treadmill with walking practice assistance 10. Problems of gait 11. Physical Cost Index
Secondary OutcomeNone

Key inclusion & exclusion criteria

Age minimum20age
Age maximum75age
Include criteria1. Within 3 months after onset of stroke/brain tumor surgery (At the start of walking exercise using Gait Exercise Assist Robot) 2. Paralysis on one side lower limb (hemiplegia or monoplexia) 3. Functional Independence Measure (FIM) walking score 4 or more 4. Risk of knee breaking in walking exercises using short leg orthosis 5. Weight 40 - 80 kg 6. Height 140 - 190 cm
Exclude criteria1. Those who may not be able to comply with the instructions of the therapist (1)Severe sensory aphasia (FIM comprehension score 2 or less) (2)Severe higher brain dysfunction (any one of FIM social interaction /memory/ problem solving is 2 or less) 2. Those who have the possibility that exercise load may lead to deterioration of physical condition (1)High blood pressure with poor control (systolic blood pressure over 160mmHg or diastolic blood pressure over 100mmHg) (2)Resting heart rate over 100/min (3)Those who have restriction of movement by cardiac or respiratory dysfunction (4)Lower limb circulation disorder and diabetic peripheral neuropathy (5)Severe joint contracture or deformity (6)Other restriction of movement for some reason 3. Those whose physical condition may be hinder safe walking exercises (1)Vision disorder, hearing disorder that impedes training (2)Possibility of incontinence that dirty robots 4. In addition, when judging that the doctor in charge is inappropriate to participate in this study.

Related Information


Public contact
Name Kazuki Murata
Address 5-1-1, Nabeshima, Saga-City, Saga, Japan Saga Japan 849-8501
Telephone +81-952-34-3285
Affiliation Saga University Hospital
Scientific contact
Name Toyoko Asami
Address 5-1-1, Nabeshima, Saga-City, Saga, Japan Saga Japan 849-8501
Telephone +81-952-34-3285
Affiliation Saga University Hospital