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

National Cheng-Kung University

Status: Completed

Conditions: Gait Analysis

Treatments: Device: 3D printing AFO, anterior AFO, off-the-shelf AFO

Study type: Interventional

Funder types: Other

Identifiers

NCT03965715

A-BR-106-005

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 3 patient groups

Gait analysis with barefoot

No Intervention group

Description:

Participants walk without assistance under gait detection.

Gait analysis with AFOs

Experimental group

Description:

Participants walk with AFOs under gait detection.

Treatment:

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

Satisfaction questionnaire

Experimental group

Description:

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

Treatment:

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