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NCT03965715
An Ankle-foot Orthosis Improves Gait Performance and Satisfaction in Stroke Patients
NA trial testing 3D printing AFO, anterior AFO, off-the-shelf AFO in Gait Analysis in 20 participants. Completed in 7 February 2019.
7 May 2017
Quick facts
| Lead sponsor | National Cheng-Kung University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 20 |
| Start date | 19 April 2017 |
| Primary completion | 7 May 2017 |
| Estimated completion | 7 February 2019 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- 3D printing AFO, anterior AFO, off-the-shelf AFO
Conditions studied
- Gait Analysis — all drugs for Gait Analysis →
Sponsor
National Cheng-Kung University Hospital
Who can join
Eligibility, any sex, with Gait Analysis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03965715
- Europe PMC full search
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Related trials
Other recruiting trials for Gait Analysis
Currently open trials in the same condition.
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Other National Cheng-Kung University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03965715 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cheng-Kung University Hospital
- Last refreshed: 28 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03965715.
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