Saeboflex Dynamic Hand Orthosis for Inpatient Rehabilitation Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485641
• Other study ID #: E-516-05
• Status: Completed
• Phase: N/A
• First received: June 11, 2007
• Last updated: June 12, 2007
• Start date: August 2005
• Est. completion date: January 2007

Study information

• Verified date: June 2007
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• SaeboFlex Dynamic Hand Orthosis

Procedure:
• Saebo F.T.M. Arm Training Program

Locations

Country	Name	City	State
United States	Kessler Institute for Rehabilitation	Chester	New Jersey
United States	Kessler Institute for Rehabilitation	East Orange	New Jersey
United States	Kessler Institute for Rehabilitation	Saddle Brook	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	Saebo, Inc.

Country where clinical trial is conducted

United States, 

External Links

•   KMRREC Website