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

NCT03965715 | Completed

• 1 other identifier: A-BR-106-005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait Analysis

Keywords

3D printed technology; Ankle-Foot Orthosis (AFO); Stroke; Gait parameters; Gait Analysis; kinetics; kinematics

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Gait analysis with barefoot

NO INTERVENTION

Participants walk without assistance under gait detection.

Gait analysis with AFOs

EXPERIMENTAL

Participants walk with AFOs under gait detection.

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

Satisfaction questionnaire

EXPERIMENTAL

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

Interventions

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

Subjects wear different AFOs and performed gait analysis.

Gait analysis with AFOs; Satisfaction questionnaire

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to walk for at least 10 meters.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: April 19, 2017
• Primary Completion: May 7, 2017
• Study Completion: February 7, 2019
• Last Updated: June 28, 2019

Record last verified: 2019-04

Locations

TW (1)