Usability and Reliability of a New Physical Therapy Tool

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
Reflexion Health, Inc.
ClinicalTrials.gov Identifier:
NCT01727856
First received: November 1, 2012
Last updated: November 12, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by Reflexion Health, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Study Population

Healthy males and femailes, ages 18-35

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727856

Locations
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
Sponsors and Collaborators
Reflexion Health, Inc.
United States Naval Medical Center, San Diego
  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 September 16, 2014