The Effects of Passive Gait Training in Complete Motor Spinal Cord Injury (SCI)

NCT01349478 | Completed Phase 1

• 1 other identifier: SHEBA-11-8422-GZ-CTIL
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Motor Complete Spinal Cord Injury

Keywords

paraplegia; tetraplegia; passive gait training; O2 consumption; exercise capacity; CVD risk factors; spasticity; pain; bladder, bowel; well being

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Reduction of risk factors for CVD

  4 and 8 weeks

Study Arms (1)

study arm

EXPERIMENTAL

Device: LOKOMAT

Interventions

LOKOMAT DEVICE

Robot-assisted gait training,8 weeks,3 sessions a week,20-45 min each session.

Also known as: driven gait orthosis

study arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and non-pregnant non-lactating female
• At least 6 months after injury
• Complete (AIS A-B) cervical (C4-8) or thoracic (T1-T6) spinal cord injury according to American Spinal Injury Association (AIS) guidelines.
• Under 100 kg and between 155 - 200 cm of height

You may not qualify if:

• History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc).
• Severe concurrent medical diseases: infections, heart or lung, pressure sores, etc
• Unstable spine or unhealed limbs or pelvic fractures
• Psychiatric or cognitive situations that may interfere with the trial
• Spasticity above 3 degree according to Ashworth scale
• Reduced range of motion of knee/hip \> 15°

Sponsors & Collaborators

• Dr. Gabriel Zeilig: lead

Study Sites (1)

Sheba medical center

Tel Litwinsky, 52620, Israel

Location

Related Publications (17)

• 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

  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.

  PMID: 17597612 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.

  PMID: 11010069 BACKGROUND

• De Vivo MJ Long term survival and causes of death in Spinal Cord Injury Clinical Outcomes from the model systems 1995

  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.

  PMID: 19781509 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.

  PMID: 9863851 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.

  PMID: 10768544 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.

  PMID: 15456347 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.

  PMID: 2059132 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.

  PMID: 2784311 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.

  PMID: 17079746 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.

  PMID: 18566951 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.

  PMID: 15069022 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.

  PMID: 8584300 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.

  PMID: 11509069 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

  BACKGROUND

MeSH Terms

Conditions

Paraplegia; Quadriplegia; Muscle Spasticity; Pain

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Gabriel Zeilig

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 6, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 28, 2016

Record last verified: 2016-12

Locations

IL (1)