SaeboVR Upper Extremity Therapy Software
SaeboVR is an FDA-cleared software system, used with the Microsoft Kinect, intended to be used to support repetitive task practice for rehabilitation of adults in a clinical or home setting consistent with Standard of Care for upper extremity (UE) rehabilitation. The system is based on simulated activities of daily living (ADLs) for the UE within a virtual world. SaeboVR uses a Microsoft Kinect Sensor to track patient shoulder and elbow movements, which are translated into equivalent movements of a graphical avatar that represents the patient in a virtual environment.
An NIH-funded clinical study was conducted by the University of Virginia (UVa) and UVa HealthSouth from February 2016 to February 2017 to assess the efficacy of the system (under the name Virtual Occupational Therapy Application, or VOTA) for use in UE rehabilitation. The study was performed under an NICHD Phase II SBIR grant (2R44HD071745-02) to Barron Associates, Inc., the developer of the SaeboVR system.
Primary investigational hypothesis: Practice of virtual ADLs would lead to an improvement in UE motor function in chronic stroke survivors, as measured by an UE sub-scale of the Fugl-Meyer assessment (FMEU) and the Wolf Motor Function Test (WMFT).
Study design: A within-subjects non-interventional control period was used to control for spontaneous recovery. Prior to using the system, all participants underwent an initial “pre-control” assessment followed by 8 weeks with no prescribed UE therapy. Participants then completed a “post-control” assessment before commencing the 8 weeks of virtual ADL therapy, during which they attended 3 sessions per week, each approximately 1 hour in duration (24 total therapy sessions). A “post-intervention” assessment was conducted after the final interventional session.
Study results: A total of 15 stroke patients meeting study inclusion and exclusion criteria completed both the control and interventional periods, as well as all three assessment sessions. The study population consisted of 9 females and 6 males. The mean age was 67.7 years (range [46, 91]). All participants were 8 months or more post-stroke and did not engage in any other form of UE therapy during their participation period.
- Mean change in the FMUE score was 6.1 (95% CI: [3.8, 8.4 units], p<0.001) for the intervention, and 0.5 (95% CI: [-1.8, 2.8 units], p=1.000) for the control (Ho: Δ Intervention = Δ Control; rejected with p=0.004).
- Mean time-to-complete the 15 WMFT tasks improved by an average of 5.1 seconds (95% CI: [-10.0, -0.3], p=0.036) for the intervention, and was 0.3 seconds worse (95% CI: [-4.6, 5.1], p=1.000) for the control.
- Mean WMFT Functional Assessment score improved by 0.48 units (95% CI: [0.19, 0.77], p=0.001) for the intervention, and was worse by 0.11 units (95% CI: [-0.40, 0.18], p=1.000) for the control.
A clinically important and statistically significant improvement in upper extremity function was found for chronic stroke patients (N = 15) who used SaeboVR for virtual ADL practice.
Adams, R.J., Lichter, M.D., Ellington, A., White, M., Armstead, K., Patrie, J.T., and Diamond, P.T. (2018) Virtual Activities of Daily Living for Recovery of Upper Extremity Motor Function. IEEE Transactions on Neural Systems and Rehabilitation Engineering, 26:1, 252-260.
Ellington, A., Adams, R., White, M., & Diamond, P. (2015). Behavioral intention to use a virtual instrumental activities of daily living system among people with stroke. American Journal of Occupational Therapy, 69, 1-8.
Adams, R.J., Lichter, M.D., Krepkovich, E.T., Ellington, A., White, M., and Diamond, P.T. (2015). Assessing Upper Extremity Motor Function in Practice of Virtual Activities of Daily Living. IEEE Transactions on Neural Systems and Rehabilitation Engineering, 23:2.