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Spinal Cord Injury clinical trials

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NCT ID: NCT00047619 Completed - Spinal Cord Injury Clinical Trials

Enhancement of Pressure Healing With Pulsatile Lavage

Start date: June 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the use of pulsatile lavage to enhance the healing of pressure ulcers in individuals with spinal cord injury (SCI). The goals will be achieved using a repeated-measures double-blinded randomized controlled study of individuals with SCI who have pelvic region pressure ulcers. A total of 60 subjects will be recruited to this study. Participants will be randomly assigned to a treatment or control group. Pulsatile lavage treatment will be administered to the treatment group daily for a 3 week period. The control group subjects will receive daily sham pulsatile lavage treatment for 3 weeks. All subjects will be monitored for a 3 week period and will continue to receive routine pressure ulcer care, i.e. dressings and bedrest with a regular turning regime during their participation in the study. All study participants will be monitored following the study period until complete closure of the pressure ulcer is achieved in order to determine total interval to final closure, including any surgical procedures required. In addition, the economic effects of pulsatile lavage treatment will be evaluated through monitoring of data collected in the Computerized Patient Record System (CPRS), including duration of admission, duration of total bedrest order and duration of treatment for pressure ulcer. This data will give an initial measure of the cost benefits that may be achieved with the use of pulsatile lavage for the treatment of pressure ulcers. Subjects will be recruited from the Louis Stokes Cleveland Veterans Affairs Medical Center (CVAMC). All individuals with spinal cord injury who are admitted to the SCI Unit with pelvic region pressure ulcers will be considered eligible for this study. Further selection criteria will be employed to screen potential participants as described below. On recruitment subjects will be randomly assigned to 2 groups of 20 subjects. The assessment methods employed will be the same for each volunteer. One group will participate in the pulsatile lavage intervention, the second group will act as controls.

NCT ID: NCT00047580 Completed - Stroke Clinical Trials

Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity.

Start date: June 2002
Phase: Phase 3
Study type: Interventional

This study is being conducted to compare the impact of somnolence (sleepiness) on cognition (awareness) as well as the safety and effectiveness of tizanidine hydrochloride capsules versus Zanaflex® (tizanidine hydrochloride tablets) taken while in the fed state (just after a meal) and in the fasted state (before a meal) in patients with moderate to severe spasticity.

NCT ID: NCT00041717 Completed - Spinal Cord Injury Clinical Trials

Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury

Start date: July 2002
Phase: Phase 3
Study type: Interventional

Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.

NCT ID: NCT00013338 Completed - Spinal Cord Injury Clinical Trials

Supported Treadmill Ambulation Training After Spinal Cord Injury

Start date: January 2000
Phase: Phase 2
Study type: Interventional

This is a randomized, controlled trial to compare supported treadmill ambulation training (STAT) to conventional gait training for improving gait speed, gait endurance, gait efficiency and muscle function in SCI subjects injured more than six months prior to start of training. Each subject will receive twelve weeks of either CGT or STAT, given as 20 minutes of training within a one-hour period per day, five days per week. These subjects will be studied baseline, 4,8 and 12 weeks of training, and three months after the end of training with a battery of tests designed to evaluate the subjects' gait and muscle function.

NCT ID: NCT00013325 Completed - Spinal Cord Injury Clinical Trials

Cardiac Disease and the Electrocardiogram in SCI Patients

Start date: October 1999
Phase: Phase 2
Study type: Observational

The purpose of this three-year study is to determine the prevalence and incidence of the different types of cardiac disease and ECG abnormalities in SCI patients. Study goals are: (i) delineation of the specific types of heart disease that occur in the SCI population as manifested both pre-clinically and clinically and (ii) demonstration of their association with ECG findings. This will enable validation of scores and algorithms using the inexpensive and widely available ECG for the prevention of heart disease as well as it's early treatment and rehabilitation in SCI patients. The findings will be helpful in demonstrating what cardiological tests are appropriate for the mandated annual evaluation of SCI patients.

NCT ID: NCT00013312 Completed - Spinal Cord Injury Clinical Trials

Effects of Acute SCI on Colonic Motility & Tone

Start date: April 1999
Phase: Phase 2
Study type: Interventional

This study will compare individuals with acute SCI to control patients in order to: 1. Determine if there are changes in colonic tone and sensation after SCI by comparing the fasting responses to the postprandial responses; 2. Determine if there are changes in colonic phasic motility after SCI by comparing the fasting responses to the postprandial responses; 3. Determine if colonic motor and sensory function after SCI change over time by repeating these studies six month later in SCI and control patients.

NCT ID: NCT00011609 Completed - Spinal Cord Injury Clinical Trials

Clinical Evaluation of a Wheelchair Mounted Robotic Arm

Start date: August 2000
Phase: Phase 2
Study type: Interventional

The primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (WMRA) to improve the functional independence of veterans with SCI. The study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm: 1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks.

NCT ID: NCT00011570 Completed - Spinal Cord Injury Clinical Trials

Electrical Control of Bladder in Spinal Cord Injury Patients

Start date: April 1998
Phase: Phase 2
Study type: Interventional

The investigators will continue their work with implanted stimulators to improve bladder and bowel function. Electrical stimulation produces simultaneous contraction of sphincters with the target organs, making emptying difficult. By optimizing electrode placement, employing a new electrode design and waveform choice, it is hoped to improve the 50% of subjects able to defecate with existing approaches. This is part of a multi-center study with multiple support sources, including Rehab R&D, PVA and a commercial stimulator company.

NCT ID: NCT00011557 Completed - Spinal Cord Injury Clinical Trials

Functional Magnetic Micturition in Patients w/SCI

Start date: January 1998
Phase: Phase 2
Study type: Interventional

This project will determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.

NCT ID: NCT00011544 Completed - Spinal Cord Injury Clinical Trials

Physical Performance Measures for Manual Wheelchair Users

Start date: January 1998
Phase: Phase 2
Study type: Interventional

The project is intended to modify the Functional Independence Measure (FIM) for manual wheelchair users. It will determine if the new measure is a better measure of community independence for manual wheelchair users than the FIM. During the Phase 1 of the study it will then use this new measure to determine whether a home exercise program increases functional independence in wheelchair users. In Phases II and III of the study 120 manual wheelchair users will participate to test and validate the new measure and to test the effectiveness of therapeutic exercise. Subjects will range in age from 20 to 79 yrs. and have a variety of disabilities.