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

Stroke Clinical Trial

Official title:

A Pilot Study Investigating the Feasibility of Using a Functional Tone Management (F.T.M.) Arm Training Program With the SaeboFlex Dynamic Hand Orthosis on an Inpatient Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489580
• Other study ID #: E-519-05
• Status: Completed
• Phase: N/A
• First received: June 20, 2007
• Last updated: July 23, 2007
• Start date: August 2005
• Est. completion date: May 2006

Study information

• Verified date: July 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: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia
• 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	East Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	Saebo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand grip strength (measured using dynamometry)		At admission and at discharge
Secondary	Length of Stay (days)		The duration of the subject's inpatient hospital stay.
Secondary	Stroke Impact Scale Score		At admission and at discharge
Secondary	Action Research Arm Test Score		At admission and at discharge
Secondary	Ashworth Assessment (Upper Extremity) Scores		At admission and at discharge
Secondary	Fugl-Meyer Assessment (Upper Extremity) Scores		At admission and at discharge
Secondary	Goniometric Range of Motion Evaluation, Passive and Active (Shoulder, Elbow, and Wrist)		At admission and at discharge
Secondary	Assessment of Active Range of Motion (Fingers, as ¼ range, ½ range, ¾ range or full range)		At admission and at discharge

External Links

•   KMRREC website