N/A
Completed N=15
FRailty WAlking Patterns (FRAP) Study
Source: ClinicalTrials.gov NCT02755129 ↗Enrolled (actual)
15
Serious AEs
—
Results posted
Mar 2020
Primary outcomePrimary: Correlation of Gait Speed Between Reveal LINQ Accelerometer, Validation Accelerometer and/or Computer Assisted Rehabilitation System by Walking Exercises — 0.97; 0.93; 0.86; 0.91 Correlation Coefficient
Summary
The aim of this study is to evaluate sit-stand phases and gait speed detection using an externally worn Reveal LINQ (TM) compared to an external reference (3D accelerometer, and/or the Computer Assisted Rehabilitation Environment (CAREN) system) in one center in the Netherlands
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation of Gait Speed Between Reveal LINQ Accelerometer, Validation Accelerometer and/or Computer Assisted Rehabilitation System by Walking Exercises |
0.97; 0.93; 0.86; 0.91; 0.91; 0.91 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic Heart Failure in New York Heart Association (NHYA) class II and class III
- Willing to sign the informed consent form.
- At least 18 years of age.
Exclusion Criteria
- • Not able to walk continuously for a period of 6 minutes and perform the walking exercises as necessary for the study protocol.
- Any known allergy to Titanium
- Any concomitant conditions which in the opinion of the investigator would not allow accurate measurement of gait and frailty parameters with an externally worn device.
- Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
- Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
Data sourced from ClinicalTrials.gov (NCT02755129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.