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The purpose of this study is to determine whether a three times per week, 2 month robotic assisted treadmill gait training program, will beneficially affect the fitness, physical and psychological well-being, and the vascular and metabolic cardiovascular risk factors in individuals with complete motor Spinal Cord Injury (SCI).
Cardiovascular morbidity and mortality are a source of increasing concern among people with SCI and their health providers. The importance of physical activity in reducing the risk of heart disease in this population is indisputable, but exercise opportunities for persons with SCI are limited by physiologic and functional factors. Decreased functional muscle mass, impaired autonomic control of myocardial function, and decreased venous return limits training responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOKOMAT | Device | Robot-assisted gait training,8 weeks,3 sessions a week,20-45 min each session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Electrical stimulation induced lower limb exercise capacity in individuals with SCI | The lower limb exercise capacity in response to electrical stimulation will be measured by the use of the ERGYS II system | 4 and 8 weeks of training |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of risk factors for CVD |
| 4 and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel Zeilig, M.D | Sheba Medical Center | Principal Investigator |
| Moshe Berg, Medical Student | Sheba Medical Center | Study Director |
| Evgeni gaidukov, M.D | Sheba Medical Center | Study Director |
| Shirley Ackerman-Laufer, B.A | Sheba Medical Center | Study Director |
| Shlomit Siman, B.A. | Sheba Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba medical center | Tel Litwinsky | 52620 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | American Spinal Injury Association/International Medical Society of Paraplegia International Standards for Neurological and Functional Classification of Spinal Cord Injury Patients. Chicago, IL: American Spinal Injury Association/International Medical Society of Paraplegia; 2000. | ||
| Background | Marino RJ Reference Manual American Spinal Cord Association 2000 | ||
| 17597612 | Background | Lucin KM, Sanders VM, Jones TB, Malarkey WB, Popovich PG. Impaired antibody synthesis after spinal cord injury is level dependent and is due to sympathetic nervous system dysregulation. Exp Neurol. 2007 Sep;207(1):75-84. doi: 10.1016/j.expneurol.2007.05.019. Epub 2007 Jun 2. | |
| 11010069 |
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| ID | Term |
|---|---|
| D010264 | Paraplegia |
| D011782 | Quadriplegia |
| D009128 | Muscle Spasticity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| Background |
| Bauman WA, Spungen AM, Adkins RH, Kemp BJ. Metabolic and endocrine changes in persons aging with spinal cord injury. Assist Technol. 1999;11(2):88-96. doi: 10.1080/10400435.1999.10131993. |
| Background | De Vivo MJ Long term survival and causes of death in Spinal Cord Injury Clinical Outcomes from the model systems 1995 |
| 19781509 | Background | Svircev JN. Cardiovascular disease in persons with spinal cord dysfunction-an update on select topics. Phys Med Rehabil Clin N Am. 2009 Nov;20(4):737-47. doi: 10.1016/j.pmr.2009.06.012. |
| 9863851 | Background | Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001. |
| 10768544 | Background | Teasell RW, Arnold JM, Krassioukov A, Delaney GA. Cardiovascular consequences of loss of supraspinal control of the sympathetic nervous system after spinal cord injury. Arch Phys Med Rehabil. 2000 Apr;81(4):506-16. doi: 10.1053/mr.2000.3848. |
| 15456347 | Background | Jacobs PL, Nash MS. Exercise recommendations for individuals with spinal cord injury. Sports Med. 2004;34(11):727-51. doi: 10.2165/00007256-200434110-00003. |
| 2059132 | Background | Bhambhani YN, Eriksson P, Steadward RD. Reliability of peak physiological responses during wheelchair ergometry in persons with spinal cord injury. Arch Phys Med Rehabil. 1991 Jul;72(8):559-62. |
| 2784311 | Background | Pollack SF, Axen K, Spielholz N, Levin N, Haas F, Ragnarsson KT. Aerobic training effects of electrically induced lower extremity exercises in spinal cord injured people. Arch Phys Med Rehabil. 1989 Mar;70(3):214-9. |
| 17079746 | Background | Israel JF, Campbell DD, Kahn JH, Hornby TG. Metabolic costs and muscle activity patterns during robotic- and therapist-assisted treadmill walking in individuals with incomplete spinal cord injury. Phys Ther. 2006 Nov;86(11):1466-78. doi: 10.2522/ptj.20050266. |
| 18566951 | Background | Hidler J, Hamm LF, Lichy A, Groah SL. Automating activity-based interventions: the role of robotics. J Rehabil Res Dev. 2008;45(2):337-44. doi: 10.1682/jrrd.2007.01.0020. |
| 15069022 | Background | Hutchinson KJ, Gomez-Pinilla F, Crowe MJ, Ying Z, Basso DM. Three exercise paradigms differentially improve sensory recovery after spinal cord contusion in rats. Brain. 2004 Jun;127(Pt 6):1403-14. doi: 10.1093/brain/awh160. Epub 2004 Apr 6. |
| 8584300 | Background | Thoumie P, Le Claire G, Beillot J, Dassonville J, Chevalier T, Perrouin-Verbe B, Bedoiseau M, Busnel M, Cormerais A, Courtillon A, et al. Restoration of functional gait in paraplegic patients with the RGO-II hybrid orthosis. A multicenter controlled study. II: Physiological evaluation. Paraplegia. 1995 Nov;33(11):654-9. doi: 10.1038/sc.1995.137. |
| 11509069 | Background | Eng JJ, Levins SM, Townson AF, Mah-Jones D, Bremner J, Huston G. Use of prolonged standing for individuals with spinal cord injuries. Phys Ther. 2001 Aug;81(8):1392-9. doi: 10.1093/ptj/81.8.1392. |
| Background | Mark S. Nash. Cardiovascular Fitness and Exercise Prescription after Spinal Cord Injury. Spinal Cord Medicine. Principles and Practice. Vernon W. Lin 2010 pages 848-855 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |