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

Gait Analysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965715
• Other study ID #: A-BR-106-005
• Status: Completed
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: February 7, 2019

Study information

• Verified date: April 2019
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 7, 2019
• Est. primary completion date: May 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gait Analysis

Intervention

Device:
• 3D printing AFO, anterior AFO, off-the-shelf AFO
Subjects wear different AFOs and performed gait analysis.

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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