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Sponsors and Collaborators: |
Kessler Medical Rehabilitation Research Center Saebo, Inc. |
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Information provided by: | Kessler Medical Rehabilitation Research Center |
ClinicalTrials.gov Identifier: | NCT00485641 |
The purpose of this study is to determine what the potential utility of the Functional Tone Management (F.T.M) Arm Training Program using the SaeboFlex in an inpatient stroke rehabiliation hospital
Condition | Intervention |
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Stroke |
Device: SaeboFlex Dynamic Hand Orthosis Procedure: Saebo F.T.M. Arm Training Program |
Study Type: | Observational |
Study Design: | Screening, Cross-Sectional, Defined Population, Prospective Study |
Official Title: | Screening of Inpatient Rehabilitation Stroke Patients for Their Potential to Qualify to Use the Saeboflex Dynamic Hand Orthosis |
Enrollment: | 222 |
Study Start Date: | August 2005 |
Study Completion Date: | January 2007 |
Therapeutic interventions for the recovery of hand function after a neurological injury have historically been very limited. A significant body of research now supports the use of an upper extremity retraining approach for functional recovery after neurological injury. Few therapeutic approaches offer any intervention specifically focused on grasp and release retraining. In an effort to address this deficit, the SaeboFlex dynamic hand orthosis was developed by occupational therapists. The F.T.M. Arm Training Program has been safely used by hundreds of occupational and physical therapists on over one thousand patients in outpatient neurological rehabilitation over the last 2 years. It is currently an accepted modality of treatment for the management of hand paresis in the acquired brain injury outpatient population. Two factors, other than the severity of the initial injury, have been clinically identified as having a significant affect on the outcomes achieved in F.T.M. Arm Training treatment. They are learned non-use and soft tissue shortening of the finger flexors. All treatment delivered to the subjects that partake in this study will be clinical care and the only research component of this study will be the assessment of outcomes. The purpose of this study is to explore the potential patient population that may qualify to use the SaeboFlex Dynamic Hand Orthosis as a therapeutic option in the inpatient population.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criterion:
United States, New Jersey | |
Kessler Institute for Rehabilitation | |
East Orange, New Jersey, United States, 07018 | |
Kessler Institute for Rehabilitation | |
Saddle Brook, New Jersey, United States, 07663 | |
Kessler Institute for Rehabilitation | |
Chester, New Jersey, United States, 07930 |
Principal Investigator: | Elie P Elovic, M.D. | Kessler Medical Rehabilitation Research & Education Center |
Study ID Numbers: | E-516-05 |
Study First Received: | June 11, 2007 |
Last Updated: | June 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00485641 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Stroke SaeboFlex Hand function |
Cerebral Infarction Stroke Vascular Diseases Brain Ischemia Central Nervous System Diseases |
Ischemia Brain Infarction Brain Diseases Infarction Cerebrovascular Disorders |
Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Brain Ischemia |
Central Nervous System Diseases Cardiovascular Diseases Brain Infarction Brain Diseases Cerebrovascular Disorders |