MedTrace Logo

Usability and Reliability of a New Physical Therapy Tool

NCT01727856 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2014-11-06

No results posted yet for this study

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.

Conditions

  • Healthy Normals

Interventions

DEVICE

Rehabilitation Measurement Tool

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

Sponsors & Collaborators

  • United States Naval Medical Center, San Diego

    collaborator FED

  • Reflexion Health, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01727856 on ClinicalTrials.gov