Usability and Reliability of a New Physical Therapy Tool

Completed

Conditions studied: Healthy Normals

In brief

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.

Key facts

Study ID

NCT01727856

Run by

Reflexion Health, Inc.

People needed

20

Starts

2012-10-01

Last updated by the study team

2014-11-06

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Males and Females
• Age 18-35

You may not qualify if…

• Active knee symptoms
• Enrollment in knee physical therapy within 3 months of evaluation
• External or implanted lower extremity prosthetics
• Administration of regularly scheduled pain medication for lower extremities including oral, topical, or intra-articular routes of delivery
• Surgery or procedures within 3 months prior to enrollment
• Previous History of traumatic Knee Injury that required surgical intervention and/or resulted in baseline knee functional disability
• Pregnant women
• Significant cognitive impairment
• Neurovestibular deficits resulting in impaired balance and proprioception
• Traumatic brain injury
• Loss of function or immobilization of both upper extremities

Where it is running

• Naval Medical Center San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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