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
  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
Official Title: Screening of Inpatient Rehabilitation Stroke Patients for Their Potential to Qualify to Use the Saeboflex Dynamic Hand Orthosis

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Sponsors and Collaborators
Kessler Foundation
Saebo, Inc.
Investigators
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:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014