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

Sponsor

National Cheng-Kung University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03965715

Collaborator

(none)

Enrollment

Location

Arms

21.7

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gait Analysis	Device: 3D printing AFO, anterior AFO, off-the-shelf AFO	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 19, 2017

Actual Primary Completion Date :

May 7, 2017

Actual Study Completion Date :

Feb 7, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cheng-Kung University	Tainan		Taiwan	701

Sponsors and Collaborators

National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Cheng-Kung University Hospital

ClinicalTrials.gov Identifier:

NCT03965715

Other Study ID Numbers:

A-BR-106-005

First Posted:

May 29, 2019

Last Update Posted:

Jun 28, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Cheng-Kung University Hospital

3D printed technology

Ankle-Foot Orthosis (AFO)

Study Results

No Results Posted as of Jun 28, 2019