Benefits of FES Cycling & LocomotorTraining Approaches after SCI

1. Benefits of FES Cycling & LocomotorTraining Approaches after SCI Deborah Backus, PT, PhD Associate Dir, SCI Research Shepherd Center Assistant Professor Emory University Atlanta, GA Academy Spinal Cord Injury Professionals Annual Meeting September 2011

2. Disclosures • Deborah Backus, PT, PhD has no financial interest or relationships to disclose • CME Staff Disclosures • Professional Education Services Group staff and planning committee have no financial interest or relationships to disclose. Academy Spinal Cord Injury Professionals Annual Meeting September 2011

3. Fact People with SCI, as well as their caregivers and clinicians, are seeking solutions to: • Increase function and recovery after SCI, as well as • Improve health and wellness Academy Spinal Cord Injury Professionals Annual Meeting September 2011

4. Potential Solutions? • Advances in neuroscience research • Development of new technology geared toward SCI • Much focus on “activity-based” interventions and programs Academy Spinal Cord Injury Professionals Annual Meeting September 2011

5. Learning Objectives Upon completion of this session, participants will: • Define activity-based interventions and discuss the relevance for improving neural activity and function, or health and wellness, in p with SCI; • Discuss the findings from relevant literature over the past 10 to 20 years related to the efficacy of activity-based interventions for improving health-related, neural and functional outcomes in p with spinal cord injury (SCI). Academy Spinal Cord Injury Professionals Annual Meeting September 2011

6. Activity-Based Interventions • Include any intervention focused on activating nerves, receptors & muscles below the level of injury rather than accommodating/compensating for the paralysis & sensory loss due to SCI by using the intact limbs only • Functional electrical stimulation cycling (FES cycling) • Locomotor training (LT) approaches Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

7. Rationale for Use of ABint for Neural & Functional Benefits? • Evidence from animal models of SCI: • Use of intense and repeated sensory stimulation, and intense motor practice, or exercise, can elicit plasticity throughout the neural axis (Hutchinson et al 2004;Ying wt al. 2008;Gazula et al. 2004;Goldschmidt et al. 2008; McDonald et al, 2002; Perez et al 2004) • Evidence from other patient populations (eg. Stroke): • Intense, focused, repeated active movement of impaired limbs, especially when combined with sensory augmentation, is beneficial for improving function, and inducing neural changes in the cerebral cortex • FES cycling and LT can provide these required elements

8. Question #1 What is the evidence in humans with SCI that the application of these principles will lead to neural changes and/or functional benefits?

9. What is required to improve health and wellness after SCI? • Need to place a demand on the cardiovascular, respiratory and musculoskeletal systems, generally using large muscle groups, BUT: • The large muscles are generally the ones that are paralyzed or weak • People with SCI have diminished cardiac responses • Autonomic dysregulation is a problem for most people with tetraplegia or high paraplegia • Both FES cycling and LT: • Activate large muscles • Place demand on the cardiovascular and respiratory systems

10. Question #2 What is the evidence that the use of activity-based interventions in humans with SCI will lead to health and wellness benefits?

11. Shepherd Center Systematic Review Group • Leadership team: Lesley Hudson, MS; David Apple, MD; Deborah Backus, PhD, PT • Reviewers: • Jennith Bernstein, PT • Amanda Gillot, PT • Jennifer Huggins, OT • Ashley Kim, PT • Elizabeth Sasso, PT • Kristen Casperson, PT • Brian Smith, PT • Anna Berry, PT • Angela Cooke, RN • Data coordinator: Rebecca Acevedo Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

12. Review conducted using a system for rating the rigor and meaning of disability research (Farkas, Rogers and Anthony, 2008). The first instrument in this system is: “Standards for Rating Program Evaluation, Policy or Survey Research, Pre-Post and Correlational Human Subjects” (Rogers, Farkas, Anthony & Kash, 2008) and “Standards for Rating the Meaning of Disability Research” (Farkas & Anthony, 2008). Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

13. Definitions • “Neural recovery” or “changes in neural function”: • Measurable changes in neural circuitry or neuronal activity at any level of the neural axis in response to injury or learning • “Functional ability”: • Includes any skill that leads to improved mobility (locomotion, bed mobility, transfers) or activities of daily living:

14. Definitions • “Exercise effects”: • Include changes or modifications in cardiorespiratory or vascular responses, metabolism, and muscle parameters (size, girth, volume, blood flow, metabolism) • “Health-related benefits”: • Include markers related to cardiac function and indicators of cardiac disease, and metabolic function and indicators of diabetes or other metabolic instability or disease Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

15. Study Designs • Experimental: Employed methods including a random assignment and a control group or a reasonably constructed comparison group • Quasi-experimental: No random assignment, but either with a control group or a reasonably constructed comparison group • Descriptive: Neither a control group, nor randomization, is used. These included case studies and reports, studies employing repeated measures, and Pre-post designs. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

16. FES Cycling Studies ERGYS Muscle Power Restorative Therapies, Baltimore, MD Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

17. Neural-related Benefits of FES Cycling • Only one of 17 articles reviewed for neural and functional effects of FES Cycling in people with SCI between 1989 and 2009 (Griffin et al. 2008) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

18. Griffin et al. 2008 • Evaluated the efficacy of FES cycling on ASIA sensory and motor scores (neural, no functional data) • 18 adults with chronic paraplegia or tetraplegia • Majority classified with incomplete injuries (n=13) • Remainder classified as complete • The method for determining these classifications was not provided Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

19. Outcome Measures & Training (Griffin et al 2008) • ASIA assessed before and after a 10-week intervention • Training 2 to 3 times/week for 10 weeks on FES cycle in an inpatient hospital • Stimulation frequency for the FES cycle = 50 Hz • Maximal stimulation intensity = 140 mA, • Adjusted to maintain a cadence of 49 rpm • Resistance was only increased by 1 kp after subject was able to cycle for three consecutive sessions for 30 minutes without interruption Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

20. Neural Outcomes (Griffin et al. 2008) • Significant improvements in ASIA LEMS scores & sensory scores • Improvements coincided with increases in cycling power over the duration of the intervention period • Suggest that the FES cycle might be a viable alternative for improving motor function in the lower extremities for individuals with incomplete SCI • BUT requires much more study Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

21. Health-related Benefits of FES Cycling • 10 papers report on cardiorespiratory, pulmonary, metabolic, muscle or vascular effects of FES Cycling in people with SCI between 1989 and 2009 • Experimental approach n=2 • Quasi-experimental approach n=1 • Descriptive n=7 Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

22. Summary: Participant Characteristics

23. Summary: Participant Characteristics

24. Summary: Participant Characteristics

25. Summary: Participant Characteristics

26. Summary: Participant Characteristics

27. Summary: Participant Characteristics

28. Summary: Participant Characteristics

29. Summary: Outcome Measures

30. Summary: Outcome Measures

31. Representation of FES Cycling Parameters in RCT

32. Results from RCTs (Demchak et al 2005 & Johnston et al. 2009) • Those who exercise with FES cycling demonstrated a non-significant 63% increase in muscle CSA after training (p=0.172), which was 171% greater than the CSA in persons in the SCI control group (p=0.05) (Demchak et al. 2005) • Children were safe using FES cycling • Children who used FES had greater increases in VO2 than those who used passive cycling (Johnston et al. 2009) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

33. Other Findings from FES Cycling Studies • All people with acute or chronic SCI were able to increase time and resistance with FES cycling (Faghri et al. 1992; Hooker et al. 1992) • Participants all demonstrated an acute exercise response (Faghri et al. 1992; Bhambhani et al 2000) • Increase in small artery compliance by 63% (p=0.05) (Zbogar et al. 2008) • Muscle oxygenation responses were quite different from able-bodied participants (Bhambani et al. 2000) • Exercising at different cadences did not appear to affect cardiorespiratory or muscle oxygenation outcomes (Fornusek et al. 2008) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

34. Other Findings from FES Cycling Studies • People with tetraplegia do not respond the same as those with paraplegia (cardiorespiratory and vascular responses) • People with tetraplegia may have more autonomic disruption • Exercise programs designed for people with tetraplegia may need to be different from those with paraplegia • Passive cycling may lead to cardiorespiratory benefits in some people with SCI • Requires careful comparison between passive and FES cycling in people with SCI • Cost/value Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

35. Summary: FES Cycling StudiesMethodological Considerations • Each study addressed different health-related problems in people with different levels, chronicity and completeness of SCI • Difficult to draw conclusions for the general SCI population • Training duration was different for these studies • Demchak et al. -13 weeks • Johnston et. al. - 6 months • Bhambhani et al. - a single testing session • Difficult to know which training paradigm would lead to the changes reported, and if another paradigm would lead to better or worse effects Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

36. Locomotor Training Studies Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

37. Neural & Functional Benefits of LT • Purpose: To evaluate all literature between 1998 and 2008 related to the efficacy for improving neural activity and function with the use of locomotor training (LT) • 40 articles pulled from the literature and 21 articles met rigor and meaningfulness criteria: • Experimental (n=3) • Quasi-experimental (n=2) • Descriptive (n=16) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

38. Neural & Functional-related Benefits of LT • Humans with INcomplete SCI trained on treadmill with manual facilitation and assistance can improve gait and overground walking (Adams et al. 2006; Hicks et al. 2005; Hornby et al, 2005; Behrman AL & Harkema SJ, 2000; Wernig et al. 1995) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

39. Health-related benefits of LT • n=8 • No reports of randomized controlled trials (RCT) evaluating the exercise or health-related benefits of BWSTT in SCI • 3 employed a control group in a quasi-experimental design, but no randomization • Remaining 5 used a descriptive study design • Used different approaches to BWSTT • BWSTT • Manual (M) • Robotic (R) • BWSTT combined with neuromuscular electrical stimulation (NMES) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

40. Summary of participant characteristics in LT Studies

41. Summary of participant characteristics in LT Studies

42. Summary of participant characteristics in LT Studies

43. Summary of participant characteristics in LT Studies

44. Summary of participant characteristics in LT Studies

45. Summary of interventions & outcome measures in the LT studies

46. Summary of interventions & outcome measures in the LT studies

47. Summary of interventions & outcome measures in the LT studies

48. Health-related Benefits of LT • Increased muscle mass acutely (Giangregorio et al. 2005), and chronically (Adams et al. 2006): • Increases in muscle fiber area and in type 1 fibers (Adams et al. 2006) • Increased in femoral artery compliance (Ditor et al. 2005) • Increased VO2, VCO2, and energy consumption (Carvalho et al. 2005, 2006) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

49. Methodological Considerations LT Studies • The data varies based on the training paradigm, the participant characteristics (level, extent and chronicity of injury), and the outcome measures used • Studies employing similar participants training with identical programs, and receiving the same outcome measures will provide valuable insight related to the positive and negative health effects of BWSTT Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

50. Conclusions from Systematic Reviews • The evidence related to neural and functional effects suggests that only people with INcomplete SCI benefit from these approaches • There are health benefits following FES cycling or LT for people with either complete or incomplete SCI • Changes in heart rate and blood pressure vary based on level of injury • People with SCI who desire pursuing FES cycling or LT should discuss which approach is best for them individually with their health care provider based on the level, extent and chronicity of their SCI. • NOT ONE SIZE FITS ALL Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation