Gait AnalysisNCT03965715
An Ankle-foot Orthosis Improves Gait Performance and Satisfaction in Stroke Patients
A study testing 3D printing AFO, anterior AFO, off-the-shelf AFO in people with Gait Analysis, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gait Analysis
- What is being tested?
- 3D printing AFO, anterior AFO, off-the-shelf AFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Apr 2017to 7 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to walk for at least 10 meters.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Energy-storable Ankle-foot Orthosis Using 3D Printing Technology
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
- Being tested
- 3D printing AFO, anterior AFO, off-the-shelf AFO
- Keywords
- 3D printed technology, Ankle-Foot Orthosis (AFO), Stroke, Gait parameters, Gait Analysis, kinetics, kinematics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printing AFO, anterior AFO, off-the-shelf AFODevice
Subjects wear different AFOs and performed gait analysis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: 3D printing AFO, anterior AFO, off-the-shelf AFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: one month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start19 Apr 2017
- Primary completion7 May 2017
- Study completion7 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait AnalysisStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965715
- Sponsor's protocol ID
- A-BR-106-005
- Status last verified
- Apr 2019
- First submitted
- 24 May 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Energy-storable Ankle-foot Orthosis Using 3D Printing Technology
- ClinicalTrials.gov ID
- NCT03965715
- Acronym / sponsor ID
- A-BR-106-005
- Conditions
- Gait Analysis
- Keywords
- 3D printed technology, Ankle-Foot Orthosis (AFO), Stroke, Gait parameters, Gait Analysis, kinetics, kinematics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 7 May 2017 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gait analysis with barefoot | No intervention | –Participants walk without assistance under gait detection. |
| Gait analysis with AFOs | Experimental | Device: 3D printing AFO, anterior AFO, off-the-shelf AFOParticipants walk with AFOs under gait detection. |
| Satisfaction questionnaire | Experimental | Device: 3D printing AFO, anterior AFO, off-the-shelf AFOUser 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Unable to walk for at least 10 meters.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printing AFO, anterior AFO, off-the-shelf AFOSubjects wear different AFOs and performed gait analysis. | Device | Gait analysis with AFOs, Satisfaction questionnaire |
Primary outcome
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.
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printing AFO, anterior AFO, off-the-shelf AFO in people with Gait Analysis, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic analysis (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.