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

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

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.

Study Overview

• Status: Completed
• Conditions: Gait Analysis
• Intervention / Treatment: Device: 3D printing AFO, anterior AFO, off-the-shelf AFO

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • National Cheng-Kung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2017
• Primary Completion (Actual): May 7, 2017
• Study Completion (Actual): February 7, 2019

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Gait Analysis; kinematics; kinetics; Gait parameters; 3D printed technology; Ankle-Foot Orthosis (AFO)
• Other Study ID Numbers: A-BR-106-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No