Effectiveness in robot-assisted gait training using R325FS

JRCT ID: jRCTs042230126

Registered date:11/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 11/01/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Training program combining robot-assisted gait training using the R325FS and exercise therapy

Outcome(s)

• Primary Outcome: Percentage of individuals who achieved gait independence

Secondary Outcome

1) Performance during robot-assisted gait training using the R325FS that has an impact on gait independence
2) Usability of the device

Key inclusion & exclusion criteria

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

Include criteria

1. Individuals who have obtained written consent to participate in this study from the individual or his/her surrogate
2. Individuals over 16 years old
3. Individuals with hemiparetic stroke within 180 days of stroke onset
4. Individuals who scored 2 or more on FIM comprehension, social interaction, problem solving, and memory
5. Individuals whose weight is between 35 kg and 100 kg
6. Individuals whose height is between 140 cm and 190 cm

Exclude criteria

1. Individuals with uncontrolled hypertension/hypotension
2. Individuals with uncontrolled cardiac or respiratory dysfunction
3. Individuals with a pacemaker device
4. Individuals with lower extremity hemodynamic disturbances that contraindicate exercise therapy
5. Individuals with fracture susceptibility of the lower limbs or spine (e.g., severe osteoporosis)
6. Individuals with heterotopic ossification of the lower extremity leading to joint range of motion limitation
7. Individuals who are pregnant or may be pregnant
8. Individuals with infectious diseases requiring isolation
9. Individuals who are unable to wear the robotic leg for any reason
10. Other individuals who are deemed inappropriate by the attending physician, principal investigator, or research assistants

Related Information

• Primary Sponsor: Otaka Yohei
• Source(s) of Monetary Support: TOYOTA MOTOR CORPORATION