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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00883142 |
Individuals with neurological deficiencies such as those who have spinal cord injury, stroke, traumatic brain injury, Parkinson's disease, and multiple sclerosis often lose their ability to ambulate over ground. Loss of functional mobility not only impedes everyday life, but may also affect many systems and organs in the body. The investigators are interested in obtaining a wide variety of data in order to obtain a better understanding of changes that occur as a result of receiving Lokomat therapy. The investigators will be studying body composition, cardiac, pulmonary, endocrine, metabolic, and molecular changes after a 12-week clinical therapy program.
Condition |
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Spinal Cord Injuries Multiple Sclerosis Stroke |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Functional and Physiological Responses to Lokomat Therapy (Pilot Study) |
Serum, plasma and for some muscle biopsy samples
Estimated Enrollment: | 80 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Description of the Clinical Lokomat Therapy program:
This is a 12-week program with 3 to 5 sessions per week. Each session includes: 15-20 minutes of patient set-up (set-up time becomes about 5 to 10 minutes after a few sessions), 5-10 minutes of warm-up, 20-40 minutes of Lokomat therapy, 5-10 minutes of cool-down, and 5-10 minutes to remove the patient from the system. During the Lokomat sessions, heart rate and blood pressure are monitored by the therapist and recorded. Work performed is measured and recorded in the Lokomat computer for time, speed, amount of weight bearing, and distance.
Description of the Research Component:
A pre and post, prospective study design will be employed. Baseline measurements (Please see below and Table 1 for detailed descriptions) will be performed prior to start of the Lokomat therapy program and then again after completion of the 12-week program. A chart review will be performed at baseline only for documentation of medical history and medications. In a subset of patients a muscle biopsy will be performed for gene expression at baseline and week 12.
As part of Clinical Care, during each of the Lokomat therapy sessions the following information is collected:
For Research purposes the following is being proposed:
Review and record work, HR, BP, Borg Scale from all clinical sessions
Baseline and Week 12 measurements (performed on a separate days or prior to the sessions):
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Lokomat Rehabilitation Clinic
Inclusion Criteria:
The inclusion criteria are based on the guidelines set by the clinical Lokomat therapy program.
Exclusion Criteria:
Contact: Pierre K Asselin | (718) 584-9000 ext 3124 | Pierre.Asselin@va.gov |
United States, New York | |
VA Medical Center, Bronx | Recruiting |
Bronx, New York, United States, 10468 | |
Contact: Pierre K Asselin 718-584-9000 ext 3124 Pierre.Asselin@va.gov | |
Principal Investigator: Ann M. Spungen, EdD | |
Sub-Investigator: Adrian Cristian |
Principal Investigator: | Ann M. Spungen, EdD | VA Medical Center, Bronx |
Responsible Party: | Department of Veterans Affairs ( Spungen, Ann - Principal Investigator ) |
Study ID Numbers: | B4162C-11 |
Study First Received: | April 16, 2009 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00883142 History of Changes |
Health Authority: | United States: Federal Government |
Lokomat Suspended walking Body Weight Supported Treadmill Training |
Autoimmune Diseases Cerebral Infarction Demyelinating Diseases Spinal Cord Diseases Stroke Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Sclerosis Trauma, Nervous System Body Weight Spinal Cord Injuries Multiple Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Autoimmune Diseases Demyelinating Diseases Immune System Diseases Spinal Cord Diseases Nervous System Diseases Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Sclerosis Trauma, Nervous System Spinal Cord Injuries Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |