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

Not Applicable

Completed

• Conditions: Gait Analysis
• Interventions: Device: 3D printing AFO, anterior AFO, off-the-shelf AFO

• Registration Number: NCT03965715
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-04-19
• Primary Completion: 2017-05-07
• Study Completion: 2019-02-07
• Status Verified: 2019-04
• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-29
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gait analysis with AFOs	3D printing AFO, anterior AFO, off-the-shelf AFO	Participants walk with AFOs under gait detection.
Satisfaction questionnaire	3D printing AFO, anterior AFO, off-the-shelf AFO	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

Primary Outcome Measures

Name	Time	Method
36-Item Short Form Survey (SF-36)	one month after intervention	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
Kinematic analysis	Baseline	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.
10 Meter Walk Test (10MWT)	Baseline	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.
Numerical rating scale	Baseline	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.
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)	Baseline	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.

Trial Locations

Locations (1)

National Cheng-Kung University; 🇨🇳 Tainan, Taiwan