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OpenTrials
Completed

NCT Number: NCT03965715

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

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.

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Key information

Conditions

Gait Analysis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng-Kung University

Tainan, 701, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D printing AFO, anterior AFO, off-the-shelf AFO

Device

Subjects wear different AFOs and performed gait analysis.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
May 29, 2019
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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