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. Academy Spinal Cord Injury Professionals
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. Academy Spinal Cord Injury Professionals
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. Academy Spinal Cord Injury Professionals
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”: “Health-related benefits”:
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. Restorative Therapies, Baltimore, MD
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 (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
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Arnold et al. 1992 12
11***
1*** 7 5
3 months
22 yrs 10 2
16-46
Bhambhani et al. 2000 14 X* X na 3 4
1-29 yrs
26-65
Demchak et al. 2005 8
X## Na
17-50
Faghri et al. 1992 13
5**
3** 6
3-16 yrs 1
21-41
Fornusek & Davis 2008 9
1-11 yrs
26-48
Hooker et al. 1992 18
4***
3***
6 months
15 yrs 17
20-56
Johnston et al. 2007
2-8 yrs
7, 9
Johnston et al. 2009 30 22 11 19
1-12 yrs
5 to 13
Theisen et al. 2002
yrs
25-41
Zbogar et al. 2008
yrs
19-51
Red rows have control group
* The only description of completeness is: “All the SCI subjects had an upper motor neuron injury with complete lower limb paralysis.” (Bhambhani et al. 2000, p. 631); ** Frankel classification (American Spinal Injury Association, 1990) (Faghri et al. 1992, p. 1086)
*** Classification was not reported in terms of AIS classification. The authors report that “Three quadriplegic subjects were diagnosed as neurologically incomplete with respect to lower limb motor function. Two subjects with paraplegia and two with quadriplegia were neurologically incomplete with respect to lower limb sensory loss and complete with respect to lower limb motor loss.” (Hooker et al, 1992, p. 471), or that “All of the patients had complete transections of the spinal cord, with the exeption of one patient with incomplete paraplegia who had sensation in his left leg.” (Arnold et al. 1992, p. 665).; ## Participants were recruited from an acute SCI unit, but the time post-SCI was not provided.

23. Summary: Participant Characteristics
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Arnold et al. 1992 12
11***
1*** 7 5
3 months
22 yrs 10 2
16-46
Bhambhani et al. 2000 14 X* X na 3 4
1-29 yrs
26-65
Demchak et al. 2005 8
X## Na
17-50
Faghri et al. 1992 13
5**
3** 6
3-16 yrs 1
21-41
Fornusek & Davis 2008 9
1-11 yrs
26-48
Hooker et al. 1992 18
4***
3***
6 months
15 yrs 17
20-56
Johnston et al. 2007
2-8 yrs
7, 9
Johnston et al. 2009 30 22 11 19
1-12 yrs
5 to 13
Theisen et al. 2002
yrs
25-41
Zbogar et al. 2008
yrs
19-51
Red rows have control group
* The only description of completeness is: “All the SCI subjects had an upper motor neuron injury with complete lower limb paralysis.” (Bhambhani et al. 2000, p. 631); ** Frankel classification (American Spinal Injury Association, 1990) (Faghri et al. 1992, p. 1086)
*** Classification was not reported in terms of AIS classification. The authors report that “Three quadriplegic subjects were diagnosed as neurologically incomplete with respect to lower limb motor function. Two subjects with paraplegia and two with quadriplegia were neurologically incomplete with respect to lower limb sensory loss and complete with respect to lower limb motor loss.” (Hooker et al, 1992, p. 471), or that “All of the patients had complete transections of the spinal cord, with the exeption of one patient with incomplete paraplegia who had sensation in his left leg.” (Arnold et al. 1992, p. 665).; ## Participants were recruited from an acute SCI unit, but the time post-SCI was not provided.

24. Summary: Participant Characteristics
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Arnold et al. 1992 12
11***
1*** 7 5
3 months
22 yrs 10 2
16-46
Bhambhani et al. 2000 14 X* X na 3 4
1-29 yrs
26-65
Demchak et al. 2005 8
X## Na
17-50
Faghri et al. 1992 13
5**
3** 6
3-16 yrs 1
21-41
Fornusek & Davis 2008 9
1-11 yrs
26-48
Hooker et al. 1992 18
4***
3***
6 months
15 yrs 17
20-56
Johnston et al. 2007
2-8 yrs
7, 9
Johnston et al. 2009 30 22 11 19
1-12 yrs
5 to 13
Theisen et al. 2002
yrs
25-41
Zbogar et al. 2008
yrs
19-51
Red rows have control group
* The only description of completeness is: “All the SCI subjects had an upper motor neuron injury with complete lower limb paralysis.” (Bhambhani et al. 2000, p. 631); ** Frankel classification (American Spinal Injury Association, 1990) (Faghri et al. 1992, p. 1086)
*** Classification was not reported in terms of AIS classification. The authors report that “Three quadriplegic subjects were diagnosed as neurologically incomplete with respect to lower limb motor function. Two subjects with paraplegia and two with quadriplegia were neurologically incomplete with respect to lower limb sensory loss and complete with respect to lower limb motor loss.” (Hooker et al, 1992, p. 471), or that “All of the patients had complete transections of the spinal cord, with the exeption of one patient with incomplete paraplegia who had sensation in his left leg.” (Arnold et al. 1992, p. 665).; ## Participants were recruited from an acute SCI unit, but the time post-SCI was not provided.

25. Summary: Participant Characteristics
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Arnold et al. 1992 12
11***
1*** 7 5
3 months
22 yrs 10 2
16-46
Bhambhani et al. 2000 14 X* X na 3 4
1-29 yrs
26-65
Demchak et al. 2005 8
X## Na
17-50
Faghri et al. 1992 13
5**
3** 6
3-16 yrs 1
21-41
Fornusek & Davis 2008 9
1-11 yrs
26-48
Hooker et al. 1992 18
4***
3***
6 months
15 yrs 17
20-56
Johnston et al. 2007
2-8 yrs
7, 9
Johnston et al. 2009 30 22 11 19
1-12 yrs
5 to 13
Theisen et al. 2002
yrs
25-41
Zbogar et al. 2008
yrs
19-51
Red rows have control group
* The only description of completeness is: “All the SCI subjects had an upper motor neuron injury with complete lower limb paralysis.” (Bhambhani et al. 2000, p. 631); ** Frankel classification (American Spinal Injury Association, 1990) (Faghri et al. 1992, p. 1086)
*** Classification was not reported in terms of AIS classification. The authors report that “Three quadriplegic subjects were diagnosed as neurologically incomplete with respect to lower limb motor function. Two subjects with paraplegia and two with quadriplegia were neurologically incomplete with respect to lower limb sensory loss and complete with respect to lower limb motor loss.” (Hooker et al, 1992, p. 471), or that “All of the patients had complete transections of the spinal cord, with the exeption of one patient with incomplete paraplegia who had sensation in his left leg.” (Arnold et al. 1992, p. 665).; ## Participants were recruited from an acute SCI unit, but the time post-SCI was not provided.

26. Summary: Participant Characteristics
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Arnold et al. 1992 12
11***
1*** 7 5
3 months
22 yrs 10 2
16-46
Bhambhani et al. 2000 14 X* X na 3 4
1-29 yrs
26-65
Demchak et al. 2005 8
X## Na
17-50
Faghri et al. 1992 13
5**
3** 6
3-16 yrs 1
21-41
Fornusek & Davis 2008 9
1-11 yrs
26-48
Hooker et al. 1992 18
4***
3***
6 months
15 yrs 17
20-56
Johnston et al. 2007
2-8 yrs
7, 9
Johnston et al. 2009 30 22 11 19
1-12 yrs
5 to 13
Theisen et al. 2002
yrs
25-41
Zbogar et al. 2008
yrs
19-51
Red rows have control group
* The only description of completeness is: “All the SCI subjects had an upper motor neuron injury with complete lower limb paralysis.” (Bhambhani et al. 2000, p. 631); ** Frankel classification (American Spinal Injury Association, 1990) (Faghri et al. 1992, p. 1086)
*** Classification was not reported in terms of AIS classification. The authors report that “Three quadriplegic subjects were diagnosed as neurologically incomplete with respect to lower limb motor function. Two subjects with paraplegia and two with quadriplegia were neurologically incomplete with respect to lower limb sensory loss and complete with respect to lower limb motor loss.” (Hooker et al, 1992, p. 471), or that “All of the patients had complete transections of the spinal cord, with the exeption of one patient with incomplete paraplegia who had sensation in his left leg.” (Arnold et al. 1992, p. 665).; ## Participants were recruited from an acute SCI unit, but the time post-SCI was not provided.

27. Summary: Participant Characteristics
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Arnold et al. 1992 12
11***
1*** 7 5
3 months
22 yrs 10 2
16-46
Bhambhani et al. 2000 14 X* X na 3 4
1-29 yrs
26-65
Demchak et al. 2005 8
X## Na
17-50
Faghri et al. 1992 13
5**
3** 6
3-16 yrs 1
21-41
Fornusek & Davis 2008 9
1-11 yrs
26-48
Hooker et al. 1992 18
4***
3***
6 months
15 yrs 17
20-56
Johnston et al. 2007
2-8 yrs
7, 9
Johnston et al. 2009 30 22 11 19
1-12 yrs
5 to 13
Theisen et al. 2002
yrs
25-41
Zbogar et al. 2008
yrs
19-51
Red rows have control group
* The only description of completeness is: “All the SCI subjects had an upper motor neuron injury with complete lower limb paralysis.” (Bhambhani et al. 2000, p. 631); ** Frankel classification (American Spinal Injury Association, 1990) (Faghri et al. 1992, p. 1086)
*** Classification was not reported in terms of AIS classification. The authors report that “Three quadriplegic subjects were diagnosed as neurologically incomplete with respect to lower limb motor function. Two subjects with paraplegia and two with quadriplegia were neurologically incomplete with respect to lower limb sensory loss and complete with respect to lower limb motor loss.” (Hooker et al, 1992, p. 471), or that “All of the patients had complete transections of the spinal cord, with the exeption of one patient with incomplete paraplegia who had sensation in his left leg.” (Arnold et al. 1992, p. 665).; ## Participants were recruited from an acute SCI unit, but the time post-SCI was not provided.

28. Summary: Participant Characteristics
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Arnold et al. 1992 12
11***
1*** 7 5
3 months
22 yrs 10 2
16-46
Bhambhani et al. 2000 14 X* X na 3 4
1-29 yrs
26-65
Demchak et al. 2005 8
X## Na
17-50
Faghri et al. 1992 13
5**
3** 6
3-16 yrs 1
21-41
Fornusek & Davis 2008 9
1-11 yrs
26-48
Hooker et al. 1992 18
4***
3***
6 months
15 yrs 17
20-56
Johnston et al. 2007
2-8 yrs
7, 9
Johnston et al. 2009 30 22 11 19
1-12 yrs
5 to 13
Theisen et al. 2002
yrs
25-41
Zbogar et al. 2008
yrs
19-51
Red rows have control group
* The only description of completeness is: “All the SCI subjects had an upper motor neuron injury with complete lower limb paralysis.” (Bhambhani et al. 2000, p. 631); ** Frankel classification (American Spinal Injury Association, 1990) (Faghri et al. 1992, p. 1086)
*** Classification was not reported in terms of AIS classification. The authors report that “Three quadriplegic subjects were diagnosed as neurologically incomplete with respect to lower limb motor function. Two subjects with paraplegia and two with quadriplegia were neurologically incomplete with respect to lower limb sensory loss and complete with respect to lower limb motor loss.” (Hooker et al, 1992, p. 471), or that “All of the patients had complete transections of the spinal cord, with the exeption of one patient with incomplete paraplegia who had sensation in his left leg.” (Arnold et al. 1992, p. 665).; ## Participants were recruited from an acute SCI unit, but the time post-SCI was not provided.

29. Summary: Outcome Measures
Cardio/
Resp
Muscular
Metabolic
Vascular
Other
Arnold et al. 1992 X
Bhambhani et al. 2000
Demchak et al. 2005
ave weekly power output
Faghri, Glaser, Faghri 1992
Fornusek & Davis et al. 2008
Power output
Hooker et al. 1992
Johnston et al. 2007
Lipid levels, BMD
Johnston et al. 2009
Lipids, cholesterol
Theisen et al. 2002
Zbogar et al. 2008

30. Summary: Outcome Measures
Cardio/
Resp
Muscular
Metabolic
Vascular
Other
Arnold et al. 1992 X
Bhambhani et al. 2000
Demchak et al. 2005
ave weekly power output
Faghri, Glaser, Faghri 1992
Fornusek & Davis et al. 2008
Power output
Hooker et al. 1992
Johnston et al. 2007
Lipid levels, BMD
Johnston et al. 2009
Lipids, cholesterol
Theisen et al. 2002
Zbogar et al. 2008

31. Representation of FES Cycling Parameters in RCT
Conditioning
Cycling
Other info or training
Device(s) used
Stim parameters
Freq
Duration
Demchak et al. 2005
30 reps of knee ext with estim and 1 kg weight or able to cycle with 2.4 watts
Began at 2 watts; 50rpm
Increased every 3, 30 min sessions by 6.1 watts
Stimaster Clinical Ergometry system
2 watts; max stim 140 mA
30 mins/day;
3 days/wk
13 weeks
Johnston et al. 2009
Lower extremity stretching prior to cycling
At home; 50rpm
RT300-P (FES) or RT100 (passive)
33Hz, 140mA
1 hour/day, 3X/wk
6 months

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 )
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 Studies Methodological 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 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 ; 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
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
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Adams et al. 2006 1 X 27
Carvalho & Cliquet 2005 21
24-40
Carvalho et al. 2005 31
23-40
Carvalho, Zanchetta, Sereni, Cliquet 2005
22-51
Ditor et al. 2005 6
19-57
Giangregorio et al. 2005 5
19-40
Giangregorio et al. 2006 14
20-53
Israel et al. 2006 12
X (1)
15-59
*Frankel classification was used to determine completeness (American Spinal Injury Association, 1990);
** Defined as “complete”, with no AIS classification provided;
***subjects were patients in an acute care setting; time post-SCI not defined further
# reported motor complete vs. motor incomplete; no AIS classification

41. Summary of participant characteristics in LT Studies
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Adams et al. 2006 1 X 27
Carvalho & Cliquet 2005 21
24-40
Carvalho et al. 2005 31
23-40
Carvalho, Zanchetta, Sereni, Cliquet 2005
22-51
Ditor et al. 2005 6
19-57
Giangregorio et al. 2005 5
19-40
Giangregorio et al. 2006 14
20-53
Israel et al. 2006 12
X (1)
15-59
*Frankel classification was used to determine completeness (American Spinal Injury Association, 1990);
** Defined as “complete”, with no AIS classification provided;
***subjects were patients in an acute care setting; time post-SCI not defined further
# reported motor complete vs. motor incomplete; no AIS classification

42. Summary of participant characteristics in LT Studies
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Adams et al. 2006 1 X 27
Carvalho & Cliquet 2005 21
24-40
Carvalho et al. 2005 31
23-40
Carvalho, Zanchetta, Sereni, Cliquet 2005
22-51
Ditor et al. 2005 6
19-57
Giangregorio et al. 2005 5
19-40
Giangregorio et al. 2006 14
20-53
Israel et al. 2006 12
X (1)
15-59
*Frankel classification was used to determine completeness (American Spinal Injury Association, 1990);
** Defined as “complete”, with no AIS classification provided;
***subjects were patients in an acute care setting; time post-SCI not defined further
# reported motor complete vs. motor incomplete; no AIS classification

43. Summary of participant characteristics in LT Studies
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Adams et al. 2006 1 X 27
Carvalho & Cliquet 2005 21
24-40
Carvalho et al. 2005 31
23-40
Carvalho, Zanchetta, Sereni, Cliquet 2005
22-51
Ditor et al. 2005 6
19-57
Giangregorio et al. 2005 5
19-40
Giangregorio et al. 2006 14
20-53
Israel et al. 2006 12
X (1)
15-59
*Frankel classification was used to determine completeness (American Spinal Injury Association, 1990);
** Defined as “complete”, with no AIS classification provided;
***subjects were patients in an acute care setting; time post-SCI not defined further
# reported motor complete vs. motor incomplete; no AIS classification

44. Summary of participant characteristics in LT Studies
AIS Classification
Level
Acute/Chronic
Sex
Age A B
C /D
Tetra
Para
Acute
Chronic M F
Adams et al. 2006 1 X 27
Carvalho & Cliquet 2005 21
24-40
Carvalho et al. 2005 31
23-40
Carvalho, Zanchetta, Sereni, Cliquet 2005
22-51
Ditor et al. 2005 6
19-57
Giangregorio et al. 2005 5
19-40
Giangregorio et al. 2006 14
20-53
Israel et al. 2006 12
X (1)
15-59
*Frankel classification was used to determine completeness (American Spinal Injury Association, 1990);
** Defined as “complete”, with no AIS classification provided;
***subjects were patients in an acute care setting; time post-SCI not defined further
# reported motor complete vs. motor incomplete; no AIS classification

45. Summary of interventions & outcome measures in the LT studies
Type
Freq
Duration
Outcome Measures M R
NMES
Cardio/
Resp
Muscular
Metabolic
Vascular
Adams et al. 2006 X
3x/wk
4 mos
Carvalho & Cliquet 2005
2x/wk
6 mos
Carvalho et al. 2005a 3X
test only
Carvalho, Zanchetta, Sereni, Cliquet 2005 1X
Ditor et al. 2005
3X/wk
Giangregorio et al. 2005
6-8 mos
Giangregorio et al. 2006
12-15 mos
Israel et al. 2006
M = manual
R = robotic

46. Summary of interventions & outcome measures in the LT studies
Type
Freq
Duration
Outcome Measures M R
NMES
Cardio/
Resp
Muscular
Metabolic
Vascular
Adams et al. 2006 X
3x/wk
4 mos
Carvalho & Cliquet 2005
2x/wk
6 mos
Carvalho et al. 2005a 3X
test only
Carvalho, Zanchetta, Sereni, Cliquet 2005 1X
Ditor et al. 2005
3X/wk
Giangregorio et al. 2005
6-8 mos
Giangregorio et al. 2006
12-15 mos
Israel et al. 2006
M = manual
R = robotic

47. Summary of interventions & outcome measures in the LT studies
Type
Freq
Duration
Outcome Measures M R
NMES
Cardio/
Resp
Muscular
Metabolic
Vascular
Adams et al. 2006 X
3x/wk
4 mos
Carvalho & Cliquet 2005
2x/wk
6 mos
Carvalho et al. 2005a 3X
test only
Carvalho, Zanchetta, Sereni, Cliquet 2005 1X
Ditor et al. 2005
3X/wk
Giangregorio et al. 2005
6-8 mos
Giangregorio et al. 2006
12-15 mos
Israel et al. 2006
M = manual
R = robotic

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

51. Conclusions: Further Study Required to:
Explore more fully the health-related effects of FES cycling and LT
Variable responses in arterial compliance and lipid profiles
Impact on ANS
Compare FES cycling & LT in relation to the benefits
Should include cost-benefit analyses
Elucidate the differential responses/benefits to FES cycling & LT approaches for different levels, completeness and chronicity of SCI
Compare FES cycling, LT approaches and upper extremity exercise for their relative contributions to health-related benefits in SCI
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

52. Thank you!
National Institute on Disability and Rehabilitation Research
Lesley Hudson, MS
David Apple, MD
Shepherd Center
Jennith Bernstein, PT
Amanda Gillot, PT
Ashley Kim, PT
Elizabeth Sasso, PT
Kristen Casperson, PT
Brian Smith, PT
Anna Berry, PT
Angela Cooke, RN
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