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

JRCT ID: jRCTs032230039

Registered date:17/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cerebral infarction and cerebral hemorrhage patients with hemiplegia and sit-to-stand disorder
• Date of first enrollment: 17/11/2023
• Target sample size: 44
• Study type: Interventional
• Intervention(s): In the HAL group, an intervention program using a lumbar-type of HAL is performed for 20 minutes once a day for a total of 9 times. In the control group, an intervention program without a lumbar-type of HAL is performed for 20 minutes once a day for a total of 9 times.

Outcome(s)

• Primary Outcome: The amount of change from baseline to the end of the intervention in the Berg Balance Scale (BBS)

Secondary Outcome

The amount of change from baseline to the end of the intervention in the Fugl-Meyer assessment of the lower limbs
The amount of change from baseline to the end of the intervention in the Brunnstrom Recovery Stage of the upper, finger, and lower limbs
The amount of change from baseline to the end of the intervention in the isometric knee extensor muscle strength (both sides)
The amount of change from baseline to the end of the intervention in the Trunk Impairment Scale
The amount of change from baseline to the end of the intervention in the Functional Ambulation Category
The amount of change from baseline to the end of the intervention in the 30-second chair stand test
The amount of change from baseline to the end of the intervention in the Functional Independence Measure (motor, cognitive, and total score)
The amount of change from baseline to the end of the intervention in the modified Rankin Scale (Japanese version). However, the change in the score will be evaluated by scoring the grade, with grade 0 being 6 points and grade 6 being 0 points.
Occurrence of diseases, etc., the occurrence of defects in test equipment
The score prior to the intervention on the Mini-Mental State Examination (only pre-assessment)
The amount of change from baseline to the end of the intervention in the motion analysis of stand-up and walking (including gait speed, steps length, and cadence), muscle activity, motion test using an acceleration sensor, brain activity, a test of brain function (functional MRI, transcranial magnetic stimulation) (only possible case)

Key inclusion & exclusion criteria

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

Include criteria

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 18 years old, in addition to the signature of the person himself/herself, a signature by a parent or guardian is also needed)
3) Patients within 2 to 21 days after onset. (The day of stroke onset is treated as day 0)
4) Patients with Functional Ambulation Category (FAC) from 0 to 2.
5) Patients with FAC of 4 or more before onset.
6) Patients who can wear the lumbar-type 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 lumbar-type of HAL due to complications such as heart disease and musculoskeletal system, which are problems during exercise.
3) Patients who cannot attach lumbar-type of HAL bio-electrode due to skin diseases.
4) Patients who participated in other interventional 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, examination findings, etc.

Related Information

• Primary Sponsor: Matsumaru Yuji
• Source(s) of Monetary Support: University of Tsukuba Hospital