Saeboflex Dynamic Hand Orthosis for Inpatient Rehabilitation Stroke Patients

June 12, 2007 updated by: Kessler Foundation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

222

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • 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
        • Kessler Institute for Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

Saebo, Inc.

Investigators

  • Principal Investigator: Elie P Elovic, M.D., Kessler Medical Rehabilitation Research & Education Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 12, 2007

First Posted (ESTIMATE)

June 13, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2007

Last Update Submitted That Met QC Criteria

June 12, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-516-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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