Functional and Physiological Responses to Lokomat Therapy (Pilot Study) (NCT00883142) | Clinical Trial Compass
CompletedNot Applicable
Functional and Physiological Responses to Lokomat Therapy (Pilot Study)
United States27 participantsStarted 2006-10
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients will have been evaluated on the Rehabilitation Service for entry into the clinical therapy program.
. Any patient who is already eligible for Lokomat therapy is a candidate for this research project.
Exclusion criteria
. Pregnant women
. History of fractures of the lower extremities
. Bone density study indicating bone loss greater than 5 standard deviations from normal.
. Fixed contractures of the ankles, knees or hips
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
This pilot study for power calculations on future studies that will characterize the potential benefits of Lokomat rehabilitation training on cardiovascular function, body composition and endocrine/metabolic function
Timeframe: After completion of 24 clinical Lokomat rehabilitation sessions
. Uncontrolled spasticity that significantly interferes with movement of lower extremities.
. Uncooperative, unmotivated patients or patients whom cannot follow instructions on a consistent basis or communicate effectively with the treating clinicians.
. Pressure ulcers over the greater trochanters, ischial tuberosities and sacrum.