- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00101543
Gait Training For Acute Stroke: Functional Neuromuscular Stimulation (FNS) and Weight Supported Treadmill Training
February 3, 2009 updated by: US Department of Veterans Affairs
Gait Training For Acute Stroke: FNS and Weight Supported Treadmill Training
Conventional rehabilitation does not restore normal, safe gait to many stroke survivors.
Functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM) improved persistent gait deficits for patients with chronic stroke (1-7 years post stroke), but required a long protocol of 6-18 months.
For chronic deficits, a shortened response to treatment (3 months) was obtained by combining FNS-IM with body weight-supported treadmill training (BWSTT).
Gains included strength, coordination, gait kinematics, walking endurance, and quality of life.
Gait deficits treated in the chronic phase are more resistant to treatment than in the early recovery phase, because chronic, abnormal movement patterns are more ingrained.
Therefore, during the early recovery phase, it is likely that a relatively greater treatment response will be obtained.
The purpose of the proposed work is to test the combination FNS-IM + BWSTT during the early recovery phase following stroke.
Hypothesis I is: FNS-IM + BWSTT will restore volitional gait more completely for subjects during the early recovery phase following stroke, compared to BWSTT alone.
Subjects will be admitted at 1-11 months after stroke.
Thirty five subjects will be randomized to one of the two treatment groups.
They will be treated for 48 sessions, four sessions/week.
Primary outcome measures will be: kinematic swing phase gait components, energy cost of gait, and an index of walking endurance.
Secondary outcome measures will be kinematic stance phase gait components and gait speed.
The second set of hypotheses will test the relationship between restoration of mobility and measurements of impairment, function and quality of life.
Study Overview
Status
Completed
Conditions
Detailed Description
Conventional rehabilitation does not restore normal, safe gait to many stroke survivors.
Functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM) improved persistent gait deficits for patients with chronic stroke (1-7 years post stroke), but required a long protocol of 6-18 months.
For chronic deficits, a shortened response to treatment (3 months) was obtained by combining FNS-IM with body weight-supported treadmill training (BWSTT).
Gains included strength, coordination, gait kinematics, walking endurance, and quality of life.
Gait deficits treated in the chronic phase are more resistant to treatment than in the early recovery phase, because chronic, abnormal movement patterns are more ingrained.
Therefore, during the early recovery phase, it is likely that a relatively greater treatment response will be obtained.
The purpose of the proposed work is to test the combination FNS-IM + BWSTT during the early recovery phase following stroke.
Hypothesis I is: FNS-IM + BWSTT will restore volitional gait more completely for subjects during the early recovery phase following stroke, compared to BWSTT alone.
Subjects will be admitted at 1-11 months after stroke.
Thirty five subjects will be randomized to one of the two treatment groups.
They will be treated for 48 sessions, four sessions/week.
Primary outcome measures will be: kinematic swing phase gait components, energy cost of gait, and an index of walking endurance.
Secondary outcome measures will be kinematic stance phase gait components and gait speed.
The second set of hypotheses will test the relationship between restoration of mobility and measurements of impairment, function and quality of life.
Additionally, co-variates will be assessed at entry into the study: gender, age, mood, co-morbidities, time since stroke, and weeks of prior rehabilitation.
Data for outcome measures will be collected at weeks 1, 6, 12, and 6 months after the end of treatment.
For Hypothesis I testing, contrasts will be made between the two treatment groups.
A separate regression model will be analyzed for each outcome measure.
The post-test score for a given primary outcome measure will serve as the dependent variable in a regression model.
The two independent variables will be the treatment assignment information (as a dichotomous variable) and the pretest score on the given outcome measure (the covariate).
In additional model analyses for the second set of hypotheses, the relationships will be ascertained between mobility restoration and impairment, function, and quality of life.
Mobility deficits following stroke pose a significant economic, social, and psychological hardship to the individual and to society.
Development of techniques that improve lower extremity function will improve the quality of life and reduce associated health care costs for patients after stroke.
The results of the proposed study have the potential to provide a new acute stroke treatment that will increase the rate of recovery, produce a more comprehensive recovery of motor function, safer gait, greater functional independence, and enhanced quality of life.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Cleveland VA Medical Center; Research Service
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stroke 1-11 months ago
- Inability to move leg normally
Exclusion Criteria:
- Pacemaker
- Progressive medical condition (i.e. Parkinsons Disease)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
January 10, 2005
First Submitted That Met QC Criteria
January 10, 2005
First Posted (Estimate)
January 11, 2005
Study Record Updates
Last Update Posted (Estimate)
February 5, 2009
Last Update Submitted That Met QC Criteria
February 3, 2009
Last Verified
January 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A3102R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Electrical Stimulation with Intramuscular Electrodes
-
US Department of Veterans AffairsCompleted
-
Kindyle BrennanCompletedNeck Pain | Shoulder Pain | Myofascial PainUnited States
-
University of Mary Hardin-BaylorCompletedNeck Pain | Shoulder Pain | Myofascial PainUnited States
-
MetroHealth Medical CenterEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do Sul; Coordenação de Aperfeiçoamento de... and other collaboratorsUnknownMyofascial Pain SyndromesBrazil
-
The University of Hong KongCompletedOocyte Retrieval | Transcutaneous Electric Nerve StimulationChina
-
Yonsei UniversityUnknownDisease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)Korea, Republic of
-
University of MichiganUnited States Department of DefenseRecruitingAmputation | Prostheses and ImplantsUnited States
-
Louis Stokes VA Medical CenterUnited States Department of Defense; Case Western Reserve UniversityRecruiting
-
Synapse BiomedicalJohns Hopkins University; Stanford University; University Hospitals Cleveland...UnknownAmyotrophic Lateral Sclerosis (ALS)United States, France