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Saeboflex Dynamic Hand Orthosis for Inpatient Rehabilitation Stroke Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00485641
Enrollment
222
Registered
2007-06-13
Start date
2005-08-31
Completion date
2007-01-31
Last updated
2007-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, SaeboFlex, Hand function

Brief 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

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.

Interventions

Sponsors

Saebo, Inc.
CollaboratorINDUSTRY
Kessler Foundation
Lead SponsorOTHER

Study design

Observational model
DEFINED_POPULATION
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026