A randomized controlled trial of HAL for the efficacy and safety in hemiplegic patients with acute stroke

JRCT ID: jRCTs032200151

Registered date:14/10/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke (cerebral infarction and cerebral hemorrhage)
• Date of first enrollment: 18/01/2021
• Target sample size: 40
• Study type: Interventional
• Intervention(s): In the HAL group, gait treatment using HAL lower limb type (for both legs or single leg) is performed for 20 minutes once a day for a total of 9 times. In the control group, conventional gait training is performed for 20 minutes once a day for a total of 9 times.

Outcome(s)

• Primary Outcome: Functional Ambulation Category (FAC)

Secondary Outcome

Mini-Mental State Examination (MMSE)
Brunnstrom Recovery Stage of lower limb
Fugl-Meyer Assessment of lower limb
Six-min walking distance (6MWD)
Comfortable gait speed, step length, cadence
Barthel Index (BI)
Functional Independence Measure (FIM)
Gait posture, motion analysis (muscle activity), evaluation using activity meter (amount of activity)
Stroke Specific QOL (SS-QOL)
Modified Rankin Scale (mRS)
Disease occurrence status
Test equipment failure

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following inclusion criteria and do not meet any of the exclusion criteria are eligible for this study enrollment.
1) Patients who can agree to the document by themselves. (However, if writing is difficult, set a writer.)
2) Patients aged 16 years or older. (If you are under 20 years old, in addition to the signature of the person himself/herself, signature by a parent or guardian is also need.
3) Patients within 7 to 21 days after onset.
4) Patients with Functional Ambulation Category (FAC) from 0 to 2.
5) Patients who can gait training using an all-in-one walker with a load-free function.
6) Patients who can be hospitalized for 4 weeks or more from the start date of the study.
7) Patients with FAC of 4 or more before onset.
8) The HAL group consists of patients who can wear the lower limb version of HAL. (Height is assumed to be 150 cm-190 cm, but the condition of use is not height, but for patients whose body size such as thigh length, lower leg length, waist width, etc. fits.)

Exclude criteria

1) Patients who have difficulty performing voluntary limb movements according to instructions due to consciousness disorder or cognitive decline.
2) Patients who have difficulty in training joint exercises or wearing HAL due to complications such as heart disease and musculoskeletal system, which are problems during exercise.
3) Patients who cannot attach HAL bio-electrode due to skin diseases.
4) Patients who participated in other studies within 12 weeks of the start of this clinical study.
5) Patient who is judged to be medically unstable by the principal investigator or member doctors after comprehensively considering physical findings, blood test findings, etc.

Related Information

• Primary Sponsor: Marushima Aiki
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research