NCT03965715

An Ankle-foot Orthosis Improves Gait Performance and Satisfaction in Stroke Patients

Development of Energy-storable Ankle-foot Orthosis Using 3D Printing Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

All participants were at least 6-month post-stroke and had unilateral limb involvement (8 right/4 left). The main inclusion criteria in selection of the participants in this study were as follows :(1) First stroke (2) At least 6 months post stroke (3) Able to stand for at least one minute without any assistive devices (4) Able to walk for at least 10 meters. All participants were instructed to walk with bare foot or with ankle-foot orthoses(AFOs) separately under gait detection of the motion capture system. Participants were further instructed to complete the 10 Meter Walk Test at a comfortable speed with BF or with AFOs separately. All participants were provided with sufficient rest between each trial. Patient demographics such as lower limb Brunnstrom stage and Modified Ashworth Scale (MAS) score were examined and recorded by experienced therapist. The satisfaction and outcome were measured by the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and SF-36. The kinematic and kinetic data were collected by Motion Analysis system.

Conditions

• Gait Analysis

Interventions

Type	Name	Description
DEVICE	3D printing AFO, anterior AFO, off-the-shelf AFO	Subjects wear different AFOs and performed gait analysis.

Timeline

• Start date: 2017-04-19
• Primary completion: 2017-05-07
• Completion: 2019-02-07
• First posted: 2019-05-29
• Last updated: 2019-06-28

Locations

1 site across 1 country: Taiwan