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Saeboflex Dynamic Hand Orthosis for Inpatient Rehabilitation Stroke Patients

NCT ID: NCT00485641

Last Updated: 2007-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-01-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Interventions

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SaeboFlex Dynamic Hand Orthosis

Intervention Type DEVICE

Saebo F.T.M. Arm Training Program

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients admitted to the Stroke Rehabilitation Program at the Kessler Institute for Rehabilitation locations (East Orange, Saddlebrook, and Chester).
* Approval from treating physician.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saebo, Inc.

INDUSTRY

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Principal Investigators

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Elie P Elovic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kessler Medical Rehabilitation Research & Education Center

Locations

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Kessler Institute for Rehabilitation

Chester, New Jersey, United States

Site Status

Kessler Institute for Rehabilitation

East Orange, New Jersey, United States

Site Status

Kessler Institute for Rehabilitation

Saddle Brook, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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E-516-05

Identifier Type: -

Identifier Source: org_study_id