Saeboflex Dynamic Hand Orthosis for Inpatient Rehabilitation Stroke Patients

This study has been completed.
Sponsor:
Collaborator:
Saebo, Inc.
Information provided by:
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00485641
First received: June 11, 2007
Last updated: June 12, 2007
Last verified: June 2007

June 11, 2007
June 12, 2007
August 2005
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Complete list of historical versions of study NCT00485641 on ClinicalTrials.gov Archive Site
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Saeboflex Dynamic Hand Orthosis for Inpatient Rehabilitation Stroke Patients
Screening of Inpatient Rehabilitation Stroke Patients for Their Potential to Qualify to Use the Saeboflex Dynamic Hand Orthosis

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

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.

Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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Stroke
  • Device: SaeboFlex Dynamic Hand Orthosis
  • Procedure: Saebo F.T.M. Arm Training Program
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
January 2007
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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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00485641
E-516-05
No
Not Provided
Kessler Foundation
Saebo, Inc.
Principal Investigator: Elie P Elovic, M.D. Kessler Medical Rehabilitation Research & Education Center
Kessler Foundation
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP