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

Study Overview
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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.

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

Conditions
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Gait Analysis

Intervention / Treatment
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* Device: 3D printing AFO, anterior AFO, off-the-shelf AFO


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Gait analysis with barefoot<br>Participants walk without assistance under gait detection. | |
| Experimental: Gait analysis with AFOs<br>Participants walk with AFOs under gait detection. | Device: 3D printing AFO, anterior AFO, off-the-shelf AFO<br>* Subjects wear different AFOs and performed gait analysis.<br>|
| Experimental: Satisfaction questionnaire<br>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 | Device: 3D printing AFO, anterior AFO, off-the-shelf AFO<br>* Subjects wear different AFOs and performed gait analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematic analysis | A total of 22 reflective markers were attached to the anatomical landmarks of participants, and a motion capture system with eight cameras was used to collect the kinematics data. | Baseline | 
| 10 Meter Walk Test (10MWT) | Each participant preformed three 10MWT trials under each condition, for a total of 9 trials, on the same day with sufficient time given to rest in between trials. | Baseline | 
| Numerical rating scale | Participant fatigue before and after the 10MWT for the 3 experimental conditions was measured via a 5-point numerical rating scale (NRS), with 1 indicating no fatigue and 5 indicating strong fatigue. | Baseline | 
| The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) | The 8 items of the questionnaire included Dimensions, Weight, Ease in Adjusting, Safety and Security, Durability , Ease of Use, Comfortable, and Effectiveness. Each item employed a 5-point scale, with 1-point representing not satisfied at all, and 5-point representing very satisfied. | Baseline | 
| 36-Item Short Form Survey (SF-36) | The eight-section questionnaire including vitality,physical functioning,bodily pain,general health perceptions, physical role functioning,emotional role functioning,social role functioning,mental health were surveyed to evaluate participant's quality of life | one month after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D printed technology, Ankle-Foot Orthosis (AFO), Stroke, Gait parameters, Gait Analysis, kinetics, kinematics