Randomized controlled trial to prove the improvement efficacy of the walking program using the wearable assistive robot HAL for the patients with hemiparesis due to stroke.

Phase 2

• Conditions: The patient with hemiparesis due to cerebrovascular disease.

• Registration Number: JPRN-UMIN000024805
• Lead Sponsor: niversity of Tsukuba Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-14
• Study Completion: 2020-12-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
10 m Maximum Walking Speed (10m MWS)

Secondary Outcome Measures

Name	Time	Method
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)