Full Text View
Tabular View
No Study Results Posted
Related Studies
Saeboflex Dynamic Hand Orthosis for Inpatient Rehabilitation Stroke Patients
This study has been completed.
First Received: June 11, 2007   Last Updated: June 12, 2007   History of Changes
Sponsors and Collaborators: Kessler Medical Rehabilitation Research Center
Saebo, Inc.
Information provided by: Kessler Medical Rehabilitation Research Center
ClinicalTrials.gov Identifier: NCT00485641
  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

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources
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

Further study details as provided by Kessler Medical Rehabilitation Research Center:

Enrollment: 222
Study Start Date: August 2005
Study Completion Date: January 2007
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485641

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

Additional Information:
No publications provided

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

Keywords provided by Kessler Medical Rehabilitation Research Center:
Stroke
SaeboFlex
Hand function

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009