Effect of Gait Relearning Robot for Individuals After Stroke

Phase 3

• Conditions: Gait disorder after stroke; Post-stroke, Gait disorders, lower limb; Gait disorders

• Registration Number: JPRN-jRCTs052200011
• Lead Sponsor: Maki Takakuni

Brief Summary

As a result of this study, there was no difference in walking speed between the two groups before and after training. However, the RAGT group showed a significant improvement in walking speed at follow-up evaluation, whereas the control group showed no change in walking speed. In addition, the joint angle range of motion during walking showed a significant increase after training only in the RAGT-treated group.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-12
• Study Completion: 2022-02-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Individuals with hemiplegia after first stroke.
2.Individuals within 6 months after the onset of stroke.
3.Individuals who can walk independently using walking aids (canes, walkers, AFO, etc.).
4.Individuals who have walking ability that were classified Functional Ambulation Category II or more, and motor function estimated as Brunnstrom Recovery Stage II-VI.

Exclusion Criteria

1.Individuals who have high cognitive decline and higher brain dysfunction, and it is difficult to understand with the research explanation.
2.Individuals with movement restriction due to respiratory, cardiovascular, urological and digestive diseases.
3.Individuals with orthopedic or other neurological diseases that limit gait.
4.Individuals with a pulse at rest of 120 / min or more, diastolic blood pressure of 120 mmHg or more, systolic blood pressure of 200 mmHg or more.
5.Individuals who are receiving the rTMS or TDCS within 3 month.
6.Individuals who have received the BT-X within 3 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ten meter walk test

Secondary Outcome Measures

Name	Time	Method
1)Fugl-Meyer Assessment on Lower Extremity<br>2)Function Independent Measure Walk item<br>3)Modified Ashworth scale<br>4)Functional Ambulation Categories<br>5)Berg Balance Scale<br>6)Timed Up and Go test (TUG)<br>7)kinematic gait analysis<br>8)Electromyography<br>9)questionnaires for therapist<br>10)questionnaires for patient