Usability and Reliability of a New Physical Therapy Tool
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy Normals |
Device: Rehabilitation Measurement Tool |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | An Evaluation of a Novel Motion Tracking Enabled Knee Physical Therapy Application With Healthy Patients to Assess Reliability and Usability |
- Reliability [ Time Frame: 30 minutes, patients followed for duration of set-up, initialization, and completion of RMT exercise protocol ] [ Designated as safety issue: No ]We have designed and plan to implement a measure, which quantifies the length of time for the subject to set-up and initialize the system which will be used to test inter-reliability of patients using the Reflexion Measurement Tool to complete the exercise protocol. After the patient completes the exercise protocol we will ask the patient to complete the Reflexion Usability Scale to provide their user feedback and experience.
- Usability [ Time Frame: 30 minutes, patients followed for duration of set-up, initialization, and completion of RMT exercise protocol ] [ Designated as safety issue: No ]The number of interactions required by the study coordinator in order for the subject to correctly set up, initialize and complete the set protocol of physical therapy exercises using the Rehabilitation Measurement Tool. The study coordinator will use the Reflexion Usability Scale to quantify and measure outcome while subject is using the system to complete the exercise protocol.
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Rehabilitation Measurement Tool
This single arm consists of all subjects which will interact with the tool under invstigation.
|
Device: Rehabilitation Measurement Tool
The Rehabilitation Measurement Tool represents a telerehabilitation tool for physical therapy.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Healthy males and femailes, ages 18-35
Inclusion Criteria:
- Healthy Males and Females
- Age 18-35
Exclusion Criteria:
- 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
Contacts and Locations More Information
Publications:
| Responsible Party: | Reflexion Health, Inc. |
| ClinicalTrials.gov Identifier: | NCT01727856 History of Changes |
| Other Study ID Numbers: | NMCSD.2012.0060, NIH CTSA 8KL2TR000110-05 |
| Study First Received: | November 1, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Reflexion Health, Inc.:
|
rehabilitation physical therapy telemedicine |
ClinicalTrials.gov processed this record on May 16, 2013