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FNS and Weight Support Treadmill Training for Gait Component Restoration Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on FNS and Weight Support Treadmill Training for Gait Component Restoration conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. FNS and Weight Support Treadmill Training for Gait Component Restoration Clinical research trials and FNS and Weight Support Treadmill Training for Gait Component Restoration healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including FNS and Weight Support Treadmill Training for Gait Component Restoration. FNS and Weight Support Treadmill Training for Gait Component Restoration Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a FNS and Weight Support Treadmill Training for Gait Component Restoration clinical trial. Participants typically obtain the most effective healthcare available for their FNS and Weight Support Treadmill Training for Gait Component Restoration condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > FNS and Weight Support Treadmill Training for Gait Component Restoration  FNS and Weight Support Treadmill Training for Gait Component Restoration
FNS and Weight Support Treadmill Training for Gait Component Restoration
For Condition: Stroke
Status: Recruiting
Sponsor(s): Department of Veterans Affairs ,
Synopsis: To date, conventional rehabilitation is not able to restore normal, safe, gait for many individuals with stroke. We have identified nine gait component deficits which respond to the FNS-IM intervention. This study will test a refined treatment protocol of 3 months duration to restore volitional gait by restoring those nine gait components simultaneously. In addition, we will incorporate into the treatment protocol a promising non-invasive technique of partial body weight-supported (BWS) gait training on a treadmill. BWS and FNS-IM have the potential to provide additive effects for the patient and restore volitional gait more quickly and more completely than would otherwise be possible with one technique alone.
Details: Stroke is the third leading cause of disability in the United States. To date, conventional rehabilitation is not able to restore normal, safe, gait for many individuals with stroke. We have identified nine gait component deficits which respond to the FNS-IM intervention. This study will test a refined treatment protocol of 3 months duration to restore volitional gait by restoring those nine gait components simultaneously. In addition, we will incorporate into the treatment protocol a promising non-invasive technique of partial body weight-supported (BWS) gait training on a treadmill. BWS and FNS-IM have the potential to provide additive effects for the patient and restore volitional gait more quickly and more completely than would otherwise be possible with one technique alone. Therefore, our first hypothesis is HYPOTHESIS I: BWS combined with FNS-IM, simultaneously applied to nine critical gait components, will restore volitional normal, safe gait to patients with chronic stroke within 3 months. An advantage of BWS gait training is that it is non-invasive. Consequently, we must demonstrate the additive advantage of FNS-IM technique alone. Therefore the second hypothesis is: HYPOTHESIS II: FNS-IM plus BWS will restore volitional gait more quickly and completely for patients with chronic stroke compared with BWS alone. A total of thirty six chronic stroke patients will be randomly divided into two treatment groups (1) FNS-IM plus BWS; (2) BWS alone. Outcome measures for hypothesis testing will be threefold : 1) Gait normality (kinematics of nine gait components); 2) Safety (number of falls); 3) Functionality (gait speed, walking endurance, and CHART, a handicap measure of mobility and activity level). Data will be collected every four weeks during the three months of treatment. Maintenance of gains will be monitored at two additional data collections at six months and one year following the end of the treatment period. Results of this study have the potential to provide the following clinically applicable information: 1. For patients with stroke, a refined treatment protocol of 3 months duration for restoration of normal, safe, volitional gait which is practical within the current healthcare milieu. 2. A definitive recommendation regarding the most effective treatment for chronic stroke patients: (1) BWS plus FNS-IM or (2) BWS alone. RESEARCH OBJECTIVES 1. Build stimulators and electrodes. 2. Obtain measures pre and post intervention for the two groups (FNS-IM + BWS; and BWS alone) to detect gains in: a) gait pattern; b) safety; c) functional capability; and d) quality of life. 3. Analyze data for the group receiving FNS-IM + BWS, in order to test Hypothesis I. 4. Produce therapy protocols for FNS-IM and BWS intervention, and treatment progression. 5. Test Hypothesis II by comparing the two treatment groups (BWS vs BWS + FNS-IM).
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Stroke patients
Total Enrollment: 36
Location and Contact Information:
Overall Study Official:
JohnFryer, , Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development service
VAMC, Cleveland *Recruiting*
Cleveland, Ohio,
United States
Recruiting Janis Daly 216-791-3800
Additional Information:
Study ID Numbers: B2226;
Study Start Date: August 2000
Record last reviewed: January 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00011596
Other Stroke Studies:
1. 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.
2. Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS)
3. Motor Learning in Stroke Patients and Healthy Volunteers
4. Warfarin Versus Aspirin Recurrent Stroke Study
5. FNS and Weight Support Treadmill Training for Gait Component Restoration
Related Studies:
Other Stroke Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
FNS and Weight Support Treadmill Training for Gait Component Restoration
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