Saeboflex Dynamic Hand Orthosis for Inpatient Rehabilitation Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485641
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : June 13, 2007
Saebo, Inc.
Information provided by:
Kessler Foundation

Brief Summary:
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 or disease Intervention/treatment
Stroke Device: SaeboFlex Dynamic Hand Orthosis Procedure: Saebo F.T.M. Arm Training Program

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 222 participants
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
Study Start Date : August 2005
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00485641

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
Sponsors and Collaborators
Kessler Foundation
Saebo, Inc.
Principal Investigator: Elie P Elovic, M.D. Kessler Medical Rehabilitation Research & Education Center

Additional Information: Identifier: NCT00485641     History of Changes
Other Study ID Numbers: E-516-05
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: June 13, 2007
Last Verified: June 2007

Keywords provided by Kessler Foundation:
Hand function

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases