Saeboflex Dynamic Hand Orthosis for Inpatient Rehabilitation Stroke Patients
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Purpose
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 |
|---|---|
|
Stroke |
Device: SaeboFlex Dynamic Hand Orthosis Procedure: Saebo F.T.M. Arm Training Program |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Cross-Sectional Time Perspective: Prospective |
| 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criterion:
- All patients admitted to the Stroke Rehabilitation Program at the Kessler Institute for Rehabilitation locations (East Orange, Saddlebrook, and Chester).
- Approval from treating physician.
Contacts and Locations| United States, New Jersey | |
| Kessler Institute for Rehabilitation | |
| Chester, New Jersey, United States, 07930 | |
| Kessler Institute for Rehabilitation | |
| East Orange, New Jersey, United States, 07018 | |
| Kessler Institute for Rehabilitation | |
| Saddle Brook, New Jersey, United States, 07663 | |
| Principal Investigator: | Elie P Elovic, M.D. | Kessler Medical Rehabilitation Research & Education Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00485641 History of Changes |
| Other Study ID Numbers: | E-516-05 |
| Study First Received: | June 11, 2007 |
| Last Updated: | June 12, 2007 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Kessler Foundation:
|
Stroke SaeboFlex Hand function |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 23, 2013