CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Rehabilitation Measurement Tooldevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01727856
NCT01727856N/ACompleted

An Evaluation of a Novel Motion Tracking Enabled Knee Physical Therapy Application With Healthy Patients to Assess Reliability and Usability

Reflexion Health, Inc.·observational·Posted Nov 16, 2012·Updated Nov 6, 2014

In Brief

An observational study evaluating Rehabilitation Measurement Tool for Healthy Normals. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Rehabilitation exercise conducted at home following injury improves clinical and functional outcomes. Optimum compliance with prescribed exercise regimens requires regular patient instruction, performance assessment, monitoring and general encouragement from healthcare staff. Exercise at home though convenient for patients is not conducive for provision of the professional support needed to maximize prescribed regimen effectiveness. Software in development by Reflexion Health Inc. along with the Naval Medical Center San Diego (NMCSD) is being designed to facilitate remote staff-patient interaction during at-home rehabilitative exercise sessions. Microsoft Kinect® will serve as the hardware platform for the designed software package tentatively called, "Reflexion." Kinect® contains a marker-less/controller-less motion tracking camera. The final Reflexion software will rely on a "Rehabilitation Measurement Tool (RMT)" to detect cardinal plane skeletal joint movement and its velocity utilizing the embedded Kinect® camera while also providing patient visual feedback via an avatar on a television screen. In this observational minimal risk study, RMT/Kinect® functional reliability and usability will be assessed. Twenty healthy subjects will physically set-up and turn-on the hardware/software system; receive exercise directions from the RMT; then conduct a series of knee exercises similar to those prescribed after anterior cruciate ligament (ACL) repair. An initial limited data set, obtained by Reflexion Health, provided validity and reliability measures. Eighteen degrees of absolute difference was detected between manual goniometry and Kinect® measurements in relevant planes of movement utilized during prescribed ACL exercise. Good relative agreement between RMT and goniometry scores was obtained (ICC = 0.89). A correctable systematic bias toward underestimation by the RMT will allow for future more accurate estimations of joint positioning improving face validity. RMT functional reliability and general usability will be expressed in this study utilizing descriptive statistics and scaled questionnaires. Hardware component malfunction (Kinect® camera, laptop, PC, or LCD television/monitor) as well as RMT internally logged software errors and failure will tallied and measured to ascertain RMT reliability. User-RMT interaction quality will be evaluated with video recordings of each set-up and exercise session. Specifically, usability measures will include: need for additional assistance setting-up or operating the RMT; number of attempts required by the subject to interact with a specific feature: time spent on specific elements during the session. Participant feedback will be elicited post-session using two scaled questionnaires: System Usability Scale (SUS)and Reflexion Usability Scale (RUS). Findings from the study will guide software modifications needed prior to implementation of future clinical studies within the NMCSD population.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Normals
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 16, 2012
Enrollment StartOct 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.6 years ago

Interventions

Rehabilitation Measurement Tooldevice

The Rehabilitation Measurement Tool represents a telerehabilitation tool for physical therapy.