Clinical study to verify the effectiveness of a knee ankle foot orthosis with MR fluid in the knee joint

Phase 1

• Conditions: stroke

• Registration Number: JPRN-UMIN000034581
• Lead Sponsor: Kawasaki Medical School

Brief Summary

MR-KAFO is a brace which can adjust the braking force of the knee joint according to the gait cycle. We use a MR-KAFO for some stroke patients with hemiplegia. As a result, it was possible to train for them to walk with a gait closer to normal gait than with conventional ring-lock knee joint KAFO or AFO (Ankle Foot Orthosis). MR-KAFO may be indicated for a relatively long period of time in stroke patients with severe to moderate paralysis.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-20
• Study Completion: 2023-12-31
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients who have no adaptation for gait training due to prolonged consciousness disturbance 2) Patients who do not understand the contents of gait training at all or refuse to train, because of severe aphasia or higher brain dysfunction. 3) Patients who are strongly tired and can not perform the gait training, because of complications such as heart diseases and kidney diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation items are neurological findings, severity of paralysis (Brunnstrome stage, SIAS), measurement of range of motion in the joints, manual muscle testing in the sound side, activities of daily living (FIM), walking evaluation. In addition, we listen to opinions on whether physical therapists are easy to use in their gait training.