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Summary of Clinical Data


Rationale:

Worldwide there are 85 million stroke survivors with approximately 15.3 and 7 million distributed across China1 and the United States2 respectively. Motor system impairments occur in 80% of patients3 with less than 10% achieving full recovery. Persistent impairments cause activity limitations, participation restrictions, reduced quality of life, and decreased well-being4.

Stoke Neuro-Rehabilitation Evidenced-Based Practices:

High intensity repetitive task practice delivered via robot-assisted therapy (or constraint induced movement therapy) is recommended to improve motor function in individuals in sup-acute and chronic care settings. These therapies have achieved the highest level of evidential support by the AHA (Class I, Level of Evidence A)4 and the Cochrane Review5.

Number of Studies:

To date, the Motus Hand and Motus Foot have been variously utilized in 24 peer-reviewed publications ranging from engineering sensor design, basic cortical network plasticity, multi-site randomized control trials, to large multi-state healthcare system implementation studies.

Chief Findings

Arm and Hand Function:

Motus Hand improves active and passive range of motion, fine and gross motor function, and strength6-11.

Activities of Daily Living:

Following 3-months of Motus Hand rehabilitation, stroke survivors increased their levels of independence in daily activities (required less assistance from either a person or device to accomplish daily tasks)10,11.

Lower Extremity Function:

Following 3-months of Motus Foot rehabilitation, stroke survivors have increased dorsiflexion force that is maintained over 4 weeks following the intervention. The Motus Foot improves gait speed and walking endurance (distance) in chronic stroke survivors7,12,13.

Cortical Networks:

Positive changes in cortical network behavior (as assessed by dynamic causal modeling) indicate that 3-months of Motus Hand rehabilitation can assist with normalization of cortical function14.

Quality of Life:

The Motus Hand improves quality of life and reduces depression symptoms7,8,10,15.

Cost:

The Motus Hand and Motus Foot have been shown to reduce cost of delivering stroke rehabilitation by between 55-65% to the healthcare system. Savings were realized through large reduction in transportation and time-costs of delivering care in a traditional clinical setting7,10.

Combination Therapies:

The Motus Hand works synergistically with existing neurorehabilitation options in two primary ways. Data support ability to amplify functional improvements when combined with standard clinical care. The Motus Hand® can also act as a bridge therapy (alternative) when insurance benefits are exhausted6,8,9.

Efficacy in Home:

To date, the Motus Hand and Motus Foot are the only robotic based neurorehabilitation therapies that have been fully deployed in the home environment. Further, their therapeutic index and safety profiles remain high even when utilized without real-time oversight of a licensed therapist7-10,15.

ionicons-v5-e

1. Wang, W. et al. Prevalence, incidence, and mortality of stroke in China: results from a nationwide population-based survey of 480 687 adults. Circulation 135, 759-771 (2017).

2. Mozaffarian, D. et al. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. circulation 131, e29-e322 (2015).

3. Rathore, S. S., Hinn, A. R., Cooper, L. S., Tyroler, H. A. & Rosamond, W. D. Characterization of incident stroke signs and symptoms: findings from the atherosclerosis risk in communities study. Stroke 33, 2718-2721 (2002).

4. Winstein, C. J. et al. Guidelines for adult stroke rehabilitation and recovery: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 47, e98-e169 (2016).

5. Mehrholz, J., Pohl, M., Platz, T., Kugler, J. & Elsner, B. Electromechanical and robot‐assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database of Systematic Reviews (2018).

6. Kutner, N. G., Zhang, R., Butler, A. J., Wolf, S. L. & Alberts, J. L. Quality-of-life change associated with robotic-assisted therapy to improve hand motor function in patients with supacute stroke: a randomized clinical trial. Physical therapy 90, 493-504 (2010).

7. Housley, S. et al. Increasing access to cost effective home-based rehabilitation for rural veteran stroke survivors. Austin journal of cerebrovascular disease & stroke 3, 1 (2016).

8. Linder, S. M. et al. Improving quality of life and depression after stroke through telerehabilitation. American Journal of Occupational Therapy 69, 6902290020p6902290021-6902290020p6902290010 (2015).

9. Wolf, S. L. et al. The HAAPI (Home Arm Assistance Progression Initiative) trial: a novel robotics delivery approach in stroke rehabilitation. Neurorehabilitation and neural repair 29, 958-968 (2015).

10. Butler, A. J. et al. Expanding tele-rehabilitation of stroke through in-home robot-assisted therapy. Int J Phys Med Rehabil 2, 1-11 (2014).

11. Rosenstein, L., Ridgel, A. L., Thota, A., Samame, B. & Alberts, J. L. Effects of combined robotic therapy and repetitive-task practice on upper-extremity function in a patient with chronic stroke. American Journal of Occupational Therapy 62, 28-35 (2008).

12. J. Lynskey, B. T., G. Abruzzo. Home-based robot-assisted ankle rehabilitation for chronic stroke survivors. (2014).

13. Peterson, S. Home-based Robot Assisted Ankle Rehabilitation for Chronic Stroke Survivors. (2014).

14. Bajaj, S. et al. Dominance of the unaffected hemisphere motor network and its role in the behavior of chronic stroke survivors. Frontiers in human neuroscience 10, 650 (2016).

15. Cherry, C. O. B. et al. Expanding stroke telerehabilitation services to rural veterans: a qualitative study on patient experiences using the robotic stroke therapy delivery and monitoring system program. Disability and Rehabilitation: Assistive Technology 12, 21-27 (2017).

Complete list of Scientific Resources for The Motus Hand and Foot.

2004, Koeneman, E. J., Schultz, R. S., Wolf, S. L., Herring, D. E., & Koeneman, J. B.. A pneumatic muscle hand therapy device. IEEE.

The development of a pneumatic muscle driven hand therapy device, the Mentor trade mark, reinforces the need for volitional activation of joint movement while concurrently offering knowledge of results about range of motion, muscle activity or resistance to movement. The device is well tolerated and has received favorable comments from stroke survivors, their caregivers, and therapists.

2005, Bharadwaj, K., Sugar, T. G., Koeneman, J. B., & Koeneman, E. J. Design of a Robotic Gait Trainer using Spring Over Muscle Actuators for Ankle Stroke Rehabilitation. Journal of Biomechanical Engineering, 127(6), 1009. doi:10.1115/1.2049333

The device is a parallel robot that incorporates two pneumatically powered, double-acting, compliant, spring over muscle actuators as actuation links which move the ankle in dorsiflexion/plantarflexion and inversion/eversion. The compliant muscles will assist the patient in a reasonable gait pattern without forcing them to follow an exact pattern. *precursor to the Foot Mentor

2005, He, J., Koeneman, E. J., Schultz, R. S., Huang, H., Wanberg, J., Herring, D. E., … & Koeneman, J. B.. Design of a robotic upper extremity repetitive therapy device. In 9th International Conference on Rehabilitation Robotics, ICORR (pp. 95-98). IEEE.

The development of a pneumatic muscle (PM) driven therapeutic device, the RUPERT™, has the potential of providing a low cost and safe take-home method of supplementing therapy in addition to in the clinic treatment. The device can also provide real-time, objective assessment of functional improvement from the therapy. *RUPERT is the precursor to the Hand Mentor

2007, Sugar, T. G., He, J., Koeneman, E. J., Koeneman, J. B., Herman, R., Huang, H., … & Swenson, P. Design and control of RUPERT: a device for robotic upper extremity repetitive therapy. IEEE transactions on neural systems and rehabilitation engineering, 15(3), 336-346.

We have tested the device on stroke survivors performing two critical activities of daily living (ADL): reaching out and self feeding. The future improvement of the device involves increased degrees-of-freedom and interactive control to adapt to a user’s physical conditions. *RUPERT is the precursor to the Hand Mentor

2008, Balasubramanian, S., Wei, R., & He, J. (2008, August). Rupert closed loop control design.IEEE Engineering in Medicine and Biology Society (pp. 3467-3470). IEEE.

An adaptive robot control strategy combining a PID-based feedback controller and an Iterative Learning Controller (ILC) is proposed for performing passive reaching tasks. Additionally, a fuzzy rule-base for estimating the learning rate for the ILC is also proposed. The proposed control scheme has the ability to adapt to different subjects for performing different reaching tasks. *RUPERT is the precursor to the Hand Mentor

2008, Rosenstein et al. “Effects of Combined Robotic Therapy and Repetitive-Task Practice on Upper-Extremity Function in a Patient With Chronic Stroke.”

The Hand Mentor provides an effective means to improve upper-extremity motor functioning and functional performance in daily tasks followed this client’s engagement in distal initiation of movement during an RTP exercise regimen that was robotically reinforced.

2010, Kutner et al. “Quality-of-Life Change Associated With Robotic-Assisted Therapy to Improve Hand Motor Function in Patients With Subacute Stroke: A Randomized Clinical Trial.”

The Hand Mentor is an effective adjunct to deliver intensive rehabilitation important in upper limb functional recovery. The Hand Mentor therapy group had a greater increase in rating of mood and a greater increase in rating of social participation. The Hand Mentor therapy group had significant improvements in stroke recovery rating Robotic-assisted therapy may be an effective alternative or adjunct to the delivery of intensive task practice interventions to enhance hand function recovery in patients with stroke.

2011, Zhang, H., Austin, H., Buchanan, S., Herman, R., Koeneman, J., & He, J. Feasibility studies of robot-assisted stroke rehabilitation at clinic and home settings using RUPERT. In 2011 IEEE International Conference on Rehabilitation Robotics (pp. 1-6). IEEE.

The system was tested in two studies. The first study involved receiving therapeutic training during three time weekly clinic visits for 4 weeks. The second study set up the robot-assisted rehabilitation system at the patients’ homes, where the therapeutic training was practiced on a daily base. Patients’ performances were assessed using clinical evaluation tools, including Wolf Motor Function Test and Fugl Meyer Assessment (FMA), both before and after the training. Both two patients in the home-application setting demonstrated functional improvement after the training. They also demonstrated significant increase in the movement smoothness on reaching some target. Both clinical tests and objective statistical tests from robot sensory data agree on the functional improvement. *RUPERT is the precursor to the Hand Mentor

2011, Zhang, H., Austin, H., Buchanan, S., Herman, R., Koeneman, J., & He, J.. Feasibility study of robot-assisted stroke rehabilitation at home using RUPERT. In The 2011 IEEE/ICME International Conference on Complex Medical Engineering (pp. 604-609). IEEE.

The therapeutic effect of repetitive therapy is best realized by long term and multiple intensive sessions per day. Our approach provides valuable information on determining therapy intensity and repetitions and monitoring progress. After one week, participants increased the practice intensity to twice a day with evidence of competency in motor control for more demanding tasks.

2013, Linder et al. “Incorporating robotic-assisted telerehabilitation in a home program to improve arm function following stroke: a case study”

The Hand Mentor robotic-assisted therapy paired with a HEP can be successfully delivered within a home environment to a person with stroke.When combined with a home exercise program, the Hand Mentor provides similar or greater improvements in upper limb function that home exercise alone. Robotic assisted therapy is an efficacious adjunct to a HEP program to elicit substantial improvements in upper extremity motor function especially in those persons with stroke who lack access to stroke rehabilitation centers.

2014, Butler et al. “Expanding Tele-rehabilitation of Stroke Through In-home Robot-assisted Therapy”

Individuals were able to make functional improvements in the use of their impaired extremities poststroke using the Hand Mentor telerehabilitation device in the home. The in-home service delivery regimen reduced the cost of therapy while expanding access to a rehabilitation modality for individuals who would not otherwise have received services.

2015, Wolf et al. “The HAAPI Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation.”

The Hand Mentor improves upper limb function to the same extent as traditional therapy interventions (home exercise program). The device is portable and has a wireless and Web-based capability of transmitting data from a home to a secured base station. As a result, the TR component may be a practical and valuable approach to delivering poststroke care when limited resources, manpower shortages, long distances, or compromised patient mobility restrict or limit access to other treatment locations; however, a more detailed selection of users will be required before this approach could become better than a home-based exercise program.

2015, Cherry et al. “Expanding stroke telerehabilitation services to rural veterans: a qualitative study on patient experiences using the robotic stroke therapy delivery and monitoring system program.”

The Hand Mentor provides a valuable rehabilitation tool to extend effective, evidence-based and specialized rehabilitation services for upper and lower limb rehabilitation especially for those with difficulty accessing therapy services because they had exhausted their benefits or because traveling to outpatient therapy was too cumbersome due to distance were able to perform therapeutic activities in the home daily (or at least multiple times per week). Participants who were still receiving formal therapy services either in-home or in the clinic were able to perform therapeutic activities in the home on the days they were not attending/receiving formal therapy

2015, Linder et al. “Improving Quality of Life and Depression After Stroke Through Telerehabilitation.”

The Hand Mentor improves quality of life and depression symptoms when utilized in the stroke survivor’s home. The results of this study provide several relevant contributions to the field of occupational therapy: Robot-assisted therapy with the Hand Mentor, improved QOL and depression measures in people less than 6 months after stroke. An 8-wk program was sufficient time to observe changes in the QOL and depression measures for this client population. Use of a robot-assisted device in the home provided an objective way for therapists to remotely monitor people after stroke through an electronic database system and a weekly phone conversation. For people after stroke with limited access to traditional therapy, home-based interventions may be a valuable intervention for continued nonmotor recovery.

2015, Andrew J. Butler, Justiss Kallos, Stephen N. Housley, Michelle C. LaPlaca, Stephen F. Traynelis, and Steven L. Wolf, “Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke.”

A relatively short duration of Hand Mentor rehabilitation (18 hours) provides significant improvement in upper limb function, grip strength, quality of life and depressive symptoms.

2016, Ostadabbas, “A Tongue-Controlled Robotic Rehabilitation: A Feasibility Study in Stroke Survivors.”

The Hand Mentor can be successfully adapted with other assistive technologies to provide new hybrid rehabilitation paradigms.

2016, Housley, “Improving upper extremity function and quality of life with a tongue driven exoskeleton: a pilot study quantifying stroke rehabilitation.”

Significant improvements in tracking performance translated into improvements in the UE portion of the Fugl-Meyer Motor Assessment, range of motion, and all subscores for the Stroke Impact Scale. Regression modeling found daily training time to be a significant positive predictor of decreases in tracking error, indicating the presence of a potential dose-response relationship. The results of this pilot study indicate that the TDS-HM system can elicit significant improvements in moderate to severely impaired stroke survivors. This pilot study gives preliminary insight into the volume of treatment time required to improve outcomes.

2016, Housley, “Increasing Access to Cost Effective Home-Based Rehabilitation for Rural Veteran Stroke Survivors.”

Home-based, robotic therapy provided by the Hand Mentor reduced costs (65%), while expanding access to a rehabilitation modality for people who would not otherwise have received care. Those who participated made clinically meaningful improvements in the use of their impaired extremities using a robotic device in the home.

2016, Bajaj, S., Housley, S. N., Wu, D., Dhamala, M., James, G. A., & Butler, A. J. (2016). Dominance of the unaffected hemisphere motor network and its role in the behavior of chronic stroke survivors. Frontiers in human neuroscience, 10, 650.

Results of the present study uncovered an important brain-behavior relationship that can be induced by the Hand Mentor intervention between the connectivity in the unaffected brain hemisphere and the motor behavior of the affected hands in stroke patients. Findings reported in this study strengthened our understanding of stroke conditions and brain plasticity in stroke survivors.

2018, Housley, Stephen N., Kathleen Fitzgerald, and Andrew J. Butler. “Telerehabilitation Robotics: Overview of approaches and clinical outcomes.” Rehabilitation Robotics. Academic Press, 2018. 333-346.

Telerehabilitation robotics is one of the newest additions to technologically mediated health care that combines established features of robot-assisted rehabilitation and telehealthcare to provide rehabilitation services at a distance. Several studies have documented clinically and statistically significant improvements in upper and lower extremity functioning, while several feasibility studies have documented improvements in high-fidelity kinematics. Telerehabilitation robotic delivery has also been shown to expand access to rehabilitation services. The only fully deployed telerehabilitation robotics platform is the Hand Mentor.