A Pilot Study Investigating the Feasibility of the Saebo Arm Training Program on an Inpatient Population

NCT ID: NCT00489580

Last Updated: 2007-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-05-31

Brief Summary

Study Objectives:

1. To document the safe and effective application of the F.T.M. Arm Training Program using the SaeboFlex to an inpatient post stroke rehabilitation population.

2. To compare functional improvements in hand and UE use achieved with the F.T.M. program as compared to generally applied therapeutic treatment approaches.

3. To develop recommendations for an inpatient retraining protocol that could then be evaluated in a multi-center trial.

4. To document the retention of UE and hand improvements after SaeboFlex training is discontinued as well as the carry over of these gains into daily function after therapy has been discontinued.

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 past two years. It is currently an accepted modality of treatment for the management of hand paresis in the acquired brain injury population. During that time, two factors, other than the severity of the initial injury, were identified as having a significant affect on the outcomes achieved in 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 proper treatment dosage and treatment protocol for the application of the F.T.M. Program to the inpatient post stroke rehabilitation population. Additionally, information on functional outcome measures will be collected and compared to a matched control group that undergoes the standard therapeutic protocol.

Conditions

Stroke; Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

SaeboFlex Dynamic Hand Orthosis

Intervention Type: DEVICE

Saebo F.T.M. Arm Training Program

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older,
• Must be seen within three full working days of admission for screening
• Alert and Oriented to person and place with the ability to complete at a minimum a one step verbal command,
• Demonstrated active range of motion of 10 degrees shoulder flexion / abduction and 10 degrees of elbow flexion / extension
• 1/4 range of volitional finger flexion when the affected hand is passively positioned in a minimum of 15degrees of wrist extension with the MCP's at neutral and PIP's / DIP's in extension
• Patient must be independent with seated posture in a chair with a firm seat and back support but no arm rests
• Patient can maintain independent seated balance when unaffected upper extremity is fully outstretched in any direction
• Admitted to inpatient stroke rehabilitation at Kessler Institute

Exclusion Criteria

• Inpatient physician unwilling to clear patient to participate
• Medically unsuitable for therapeutic intervention,
• Using the affected hand and arm, able to volitionally grasp and release a racquet ball x10 at maximal volitional shoulder flexion with wrist extension of 10 degrees or more.
• Flaccidity in the affected UE or hand
• Fixed joint deformities, contractures or joint hypermobility that prevents proper joint positioning in the orthosis.
• Hx of rheumatoid arthritis, carpal tunnel syndrome or other hand neuropathy
• Moderate to severe weeping or pitting edema
• No previous stroke prior to the one prompting admission

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saebo, Inc.

INDUSTRY

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Principal Investigators

Elie P Elovic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kessler Medical Rehabilitation Research & Education Center

Locations

Kessler Institute for Rehabilitation

East Orange, New Jersey, United States

Countries

United States

Other Identifiers

E-519-05

Identifier Type: -

Identifier Source: org_study_id