Observational study on HAL lower limb model, non medical for non-acute stroke

JRCT ID: jRCT1030220498

Registered date:08/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-acute stroke
• Date of first enrollment: 16/12/2022
• Target sample size: 10
• Study type: Observational

Outcome(s)

• Primary Outcome: SAFETY

Secondary Outcome

2MWT
6MWT
10mWT
Functional Independence Measure:FIM
Functional Ambulation Categories:FAC
EuroQol 5 dimensions 5-level:EQ-5D-5L
Berg Balance Scale:BBS
Fugl-Meyer Assessment-LE:FMA- LE

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Non-acute stroke patients with gait disturbance due to stroke who can give written consent in person. Suppose the research subject has sufficient capacity to consent but has difficulty writing due to paralysis. In that case, a witness should be present to confirm that the subject agrees to participate in the research and to obtain written consent on their behalf.
2. Patients who are at least 18 years of age at the time consent is obtained
3. Patients who have had the first stroke for at least four weeks.
4. Patients who are unable to safely walk 10 m independently without a cane, walker or other aid and without holding on due to gait disturbance caused by stroke and who can walk at least 10 m with light assistance or by holding on or using a cane, walker or mobile hoist (lower limb prosthetic devices may be used when necessary).
5. Patients weighing 40 and 100 kg are within 150-190 cm in height and can be fitted with a HAL lower limb type for independence. However, even if the measurement is outside this range, patients should be able to be fitted if their body size, such as thigh length, lower leg length, and waist width, is appropriate.
6. Patients who can make either outpatient visits or hospital admissions per the study schedule during the study period.

Exclude criteria

1. Patients deemed difficult to perform gait training or assessment due to dyspnoea on exertion, heart failure, arrhythmia, and myocardial infarction.
2. Patients for whom it is deemed difficult to perform appropriate gait training or assessment due to cognitive impairment or higher brain dysfunction.
3. Patients with osteoarthritis of the hip or knee, poorly controlled rheumatoid arthritis, osteoarthritis and osteoarthritis of the skeletal system, such as scoliosis and scoliosis, who are considered to have severe deformities that make gait training difficult or worsen with gait training.
4. Patients with gait disorders due to diseases of the brain, spinal cord, peripheral nerves or muscles other than gait disorders due to stroke.
5. Patients with complications such as bleeding tendency or osteoporosis may cause problems in gait training.
6. Patients with serious hepatic, renal or cardiovascular disorders (serious disorders are judged regarding Grade 3 in the "Criteria for Classification of Severity of Adverse Reactions to Drugs and Other Products", Notification No. 80, Safety Division, Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare).

Related Information

• Primary Sponsor: Nakajima Takashi
• Source(s) of Monetary Support: CYBERDYNE INC.