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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965715
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gait Analysis Device: 3D printing AFO, anterior AFO, off-the-shelf AFO Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 19, 2017
Actual Primary Completion Date : May 7, 2017
Actual Study Completion Date : February 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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.




Primary Outcome Measures :
  1. Kinematic analysis [ Time Frame: 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.

  2. 10 Meter Walk Test (10MWT) [ Time Frame: 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.

  3. Numerical rating scale [ Time Frame: 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.

  4. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) [ Time Frame: 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.

  5. 36-Item Short Form Survey (SF-36) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965715


Locations
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Taiwan
National Cheng-Kung University
Tainan, Taiwan, 701
Sponsors and Collaborators
National Cheng-Kung University Hospital
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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT03965715    
Other Study ID Numbers: A-BR-106-005
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cheng-Kung University Hospital:
3D printed technology
Ankle-Foot Orthosis (AFO)
Stroke
Gait parameters
Gait Analysis
kinetics
kinematics