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

NCT ID: NCT03965715

Last Updated: 2019-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2019-02-07

Brief Summary

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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.

Detailed Description

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Conditions

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Gait Analysis

Keywords

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3D printed technology Ankle-Foot Orthosis (AFO) Stroke Gait parameters Gait Analysis kinetics kinematics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Gait analysis with barefoot

Participants walk without assistance under gait detection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Gait analysis with AFOs

Participants walk with AFOs under gait detection.

Group Type EXPERIMENTAL

3D printing AFO, anterior AFO, off-the-shelf AFO

Intervention Type DEVICE

Subjects wear different AFOs and performed gait analysis.

Satisfaction questionnaire

User feedback from the participants was obtained by questionnaire, the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and SF-36, to compare the satisfaction of AFOs

Group Type EXPERIMENTAL

3D printing AFO, anterior AFO, off-the-shelf AFO

Intervention Type DEVICE

Subjects wear different AFOs and performed gait analysis.

Interventions

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3D printing AFO, anterior AFO, off-the-shelf AFO

Subjects wear different AFOs and performed gait analysis.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* First stroke
* At least 6 months post-stroke
* Able to stand for at least one minute without any assistive devices
* Able to walk for at least 10 meters.

Exclusion Criteria

* Unable to walk for at least 10 meters.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cheng-Kung University

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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A-BR-106-005

Identifier Type: -

Identifier Source: org_study_id