The patient with hemiparesis due to cerebrovascular disease.
Conditions
Interventions
Walking program wearing HAL-TS01
Walking program without HAL-TS01
Sponsors
University of Tsukuba Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.1st inclusion (1)The patient who the agreement document is possible by himself. (2)The patient who is less than five months after the onset by stroke. (3)The patient who the wearing of HAL is possible. (4)The patient who is available hospitalization during study period. 2. 2nd inclusion (1)The patient who 10m MWS is 30-60 m/min at the last measurement of the pre-observation period. (2)The patient who the improvement ratio is under 10%, 5%, and 5% sequentially for 3 weeks in the pre-observation period. The averaged value is the mean of 10m MWS of the week previous two and the week concerned. The improvement ratio is calculated from the 3 averaged values.
Exclusion criteria
Exclusion criteria: 1.1st Exclusion (1)The patient with subarachnoid hemorrhage. (2)The patient who can walk outdoor independently. (3)The patient who investigator/subinvestigotor recognized the following symptom. 1)The patient who have akinesia, rigidity, and ataxia with high grade. 2)The patient whom rehabilitation cannot be performed to in the training room. 3)The patient who cannot understand the command and have communication. 4)The patient who has muscle spasm, deformity and contracture on the lower extremity with high grade. (4)The patient who caused waling disorder due to the spinal disease, the peripheral nerve disease, muscle disease, and injury except stroke, and has sever sensory disturbance, and severe lower limbs ischemic disease. (5)The patient who has liver damage, renal damage, cardiovascular disease, and respiratory disease with high grade. (6)The patient with the malignant tumor that does not cure radically. (7)The patient who cannot make the electrode adherent to the body surface by skin disease. (8)The patient who needs hospitalization treatment by the bone fracture, contusion, injury, and its complication in 3months before the pre-observation period. (9)The patient who the bleeding tendency and osteoporosis with the problem on the walking practice. (10)The patient who was included to other clinical trials in 3 months before the 1st inclusion, or has the plan to participate with others. (11)The patient who did walking practice using other robot equipment. (12)The patient who MD judged it no good to participate to the clinical trial. 2.2nd Exclusion (1)The patient who cannot do operation of HAL by CVC mode on the hip joint or knee joint at the end of pre-observation period. (2)The patient who MD judged it no good to participate to the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 10 m Maximum Walking Speed (10m MWS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Averaged step length and Cadence at 10m MWS 2. Asymmetry ratio at 10m MWS 3. 6-Minute walk Distance(6MD) 4. Functional Ambulation Categories (FAC) 5. Berg Balance Scale (BBS) 6. Fugl-Meyer Assessment (FMA) | — |
Countries
Japan
Contacts
Public ContactKoichi Hashimoto
University of Tsukuba, Tsukuba Clinical Research & Development Organization Clinical Research Service Center
Outcome results
None listed