Study of the Robot-Assisted Gait Training using Biopotential Signals

JRCT ID: jRCTs042230088

Registered date:11/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: stroke
• Date of first enrollment: 05/12/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

HAL group: Emphasis is placed on the mode that senses signals from electrodes attached to the body and adjusts the amount of assistance. In the HAL group, a total of 10 HAL treatments will be performed over 4 weeks.
Control group: A group that receives only conventional rehabilitation therapy. In the control group, a total of 10 conventional rehabilitation treatments are performed over 4 weeks.

Outcome(s)

• Primary Outcome: Walking speed

Secondary Outcome

1)walking independence,
2)locomotor function
3)quality of life
4)endurance
5)spatiotemporal parameters
6)electromyography
7)motor evoked potential
8)resting brain activity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

(1) 18 years old or older but under 90 years old
(2) Ability to walk on their own or with assistance before onset
(3) Patients who have obtained written consent from the patient or family about participation in this study

Exclude criteria

(1) Difficulty in communication due to consciousness disorder, cognitive dysfunction, history of mental illness, or complications
(2) Difficulty wearing HAL due to body deformation
(3) difficulty to attach electrodes due to skin diseases, etc.
(4) Use of implanted active medical devices or electronic devices (e.g. pacemakers)
(5) Difficulty in intensive training due to heart disease or other physical conditions
(6) Extreme osteoporosis or unstable fracture
(7) When the investigator/subinvestigator deems it inappropriate

Related Information

• Primary Sponsor: Ueki Yoshino