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NCT03329326
Comparison of Prosthetic Assessment Tools and Factors Influencing the Outcome
trial testing Functional tests and self-reported questionnaires in Amputation in 73 participants. Completed in 1 April 2019.
15 February 2019
Quick facts
| Lead sponsor | Medical University of Vienna |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 73 |
| Start date | 1 November 2017 |
| Primary completion | 15 February 2019 |
| Estimated completion | 1 April 2019 |
| Sites | 7 locations across Finland, Austria, Sweden, Germany, Norway |
Drugs / interventions tested
- Functional tests and self-reported questionnaires
Conditions studied
- Amputation — all drugs for Amputation →
- Prosthesis User — all drugs for Prosthesis User →
Sponsor
Medical University of Vienna
Who can join
Adults 16 to 85, any sex, with Amputation or Prosthesis User. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background and rational: A large number of instruments exists to assess upper limb prosthetic function. However, they differ substantially in terms of psychometric properties and content. Furthermore, there is no "gold standard" and nearly every single center uses a unique set of instruments. This fact prevents the linking of the commonly small (due to the limited number of patients in each center) data sets of different centers and makes comparisons between different fittings or treatment protocols difficult. To generate accepted evidence, we need large data sets with similar outcomes. With remarkable progress made in prosthetic research and rehabilitation in the recent years, the need to evaluate the impact of this intervention on daily life, including productivity, self-care and leisure becomes increasingly relevant. Moreover, self-reported instruments and observation-based instruments exist, but there is a lack of data if, for example, the self-reported instrument (which is easier and less health-professional's-time-consuming to perform) could "replace" a performance or observation-based instrument. Therefore, the aim of this study is to determine psychometric properties of the existing instruments (SHAP, DASH, SF-36 and ACMC) in a large international data set, to explore possible linkage between self-reported and performance or observation-based instruments and to develop state-of-the art recommendations/points to consider on how to assess functioning in prosthetic care.
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 NCT03329326
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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 NCT03329326 (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 Medical University of Vienna
- Last refreshed: 8 July 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/NCT03329326.
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