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

Completed

Phase N/A Results N/A

Trial Description

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

Interventions

  • SaeboFlex Device
    Other Names: functional dynamic orthosis
    Intervention Desc: The SaeboFlex allows individuals suffering from neurological impairments such as stroke the ability to incorporate their hand functionally in therapy and at home by supporting the weakened wrist, hand, and fingers. The SaeboFlex is a custom fabricated orthosis that is non-electrically based and is purely mechanical.
  • SaeboFlex Dynamic Hand Orthosis Device
  • Saebo F.T.M. Arm Training Program Procedure

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized into a study group (who will have application of the F.T.M. Program to the inpatient post stroke rehabilitation population) and a matched control group that undergoes the standard therapeutic protocol. Information on functional outcome measures will be collected and compared to the matched control group. Both groups will have hand grip strength (measured using dynamometry), Length of Stay (days), Stroke Impact Scale Score, Action Research Arm Test Score, Ashworth Assessment (Upper Extremity) Scores, Fugl-Meyer Assessment (Upper Extremity) Scores, Goniometric Range of Motion Evaluation, Passive and Active (Shoulder, Elbow, and Wrist), and Assessment of Active Range of Motion (Fingers, as ¼ range, ½ range, ¾ range or full range) will be assessed at admission and discharge.

Outcomes

Type Measure Time Frame Safety Issue
Primary Hand grip strength (measured using dynamometry)
Secondary Length of Stay (days); Stroke Impact Scale Score; Action Research Arm Test Score; Ashworth Assessment (Upper Extremity) Scores; Fugl-Meyer Assessment (Upper Extremity) Scores; Goniometric Range of Motion Evaluation, Passive and Active (Shoulder, Elbow, and Wrist); Assessment of Active Range of Motion (Fingers, as ¼ range, ½ range, ¾ range or full range).
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

Sponsors