Effects of early robot-assisted gait training on improvement of gait independence in patients with hemiparetic stroke

Phase 2

Recruiting

• Conditions: Stroke

• Registration Number: JPRN-jRCTs042230040
• Lead Sponsor: Otaka Yohei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. patients whose consent to participate in this study has been obtained in writing from the individual or his/her surrogate
2. patients whose age is between 16 and 90 years old
3. patients with hemiplegia due to first-ever supratentorial cerebral infarction or cerebral hemorrhage
4. patients with 6 or less points in the total score of the Stroke Impairment Asssessment Set lower limb motor items at the pre-intervention evaluation
5. patients with 1 or less points in Functional Ambulation Category at the pre-intervention evaluation.
6. patients with 4 points on the E item and 6 points on the M item in the Glasgow Coma Scale at the pre-intervention evaluation.
7. patients who weigh more than 35 kg and less than 100 kg
8. patients with height between 140 cm and 190 cm

Exclusion Criteria

1. patients with a history of stroke, excluding patients who had no symptoms of previous stroke despite imaging findings that indicated a history of stroke.
2. patients who had gait disorder before stroke due to neuromuscular or locomotor diseases.
3 patients who have participated in other intervention studies on motor function of lower limb and trunk and gait
4 patients with a history of epileptic seizures within 2 years, including seizures caused by the current stroke
5.patients with cardiovascular or respiratory disease that makes exercise therapy difficult
6. patients with uncontrolled hypertension
7. patients with severe osteoporosis of the lower limbs or spine.
8. patients with heterotopic ossification of the lower extremity leading to joint range of motion limitation
9. patients who are pregnant or may become pregnant
10. patients with infectious diseases which require isolation
11. patients with urinary or fecal incontinence to the point of welwalk contamination
12. patients who are unable to wear the robotic leg due to oversized or deformed lower limbs or pressure ulcers
13. other patients who are deemed inappropriate by the attending physician, principal investigator, or research assistants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified