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

NCT ID: NCT01349478

Last Updated: 2016-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-05-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Motor Complete Spinal Cord Injury

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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study arm

Group Type EXPERIMENTAL

LOKOMAT

Intervention Type DEVICE

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

Interventions

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LOKOMAT

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

Intervention Type DEVICE

Other Intervention Names

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driven gait orthosis

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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°
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Gabriel Zeilig

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Gabriel Zeilig

Dr. Gabriel Zeilig

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gabriel Zeilig, M.D

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Moshe Berg, Medical Student

Role: STUDY_DIRECTOR

Sheba Medical Center

Evgeni gaidukov, M.D

Role: STUDY_DIRECTOR

Sheba Medical Center

Shirley Ackerman-Laufer, B.A

Role: STUDY_DIRECTOR

Sheba Medical Center

Shlomit Siman, B.A.

Role: STUDY_DIRECTOR

Sheba Medical Center

Locations

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Sheba medical center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND

Marino RJ Reference Manual American Spinal Cord Association 2000

Reference Type 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.

Reference Type BACKGROUND
PMID: 17597612 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11010069 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 19781509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9863851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10768544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15456347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2059132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2784311 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17079746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18566951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15069022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8584300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11509069 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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SHEBA-11-8422-GZ-CTIL

Identifier Type: -

Identifier Source: org_study_id