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NCT03965715

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

Completed NA Last updated 28 June 2019
What this trial tests

NA trial testing 3D printing AFO, anterior AFO, off-the-shelf AFO in Gait Analysis in 20 participants. Completed in 7 February 2019.

Timeline
19 April 2017
Primary endpoint
7 May 2017
7 February 2019

Quick facts

Lead sponsorNational Cheng-Kung University Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment20
Start date19 April 2017
Primary completion7 May 2017
Estimated completion7 February 2019
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

National Cheng-Kung University Hospital

Who can join

Eligibility, any sex, with Gait Analysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Gait Analysis

Currently open trials in the same condition.

Other National Cheng-Kung University Hospital trials

Trials by the same sponsor.

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Data sources for this page

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