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

July 23, 2007 updated by: Kessler Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • Kessler Institute for Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hand grip strength (measured using dynamometry)
Time Frame: At admission and at discharge
At admission and at discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of Stay (days)
Time Frame: The duration of the subject's inpatient hospital stay.
The duration of the subject's inpatient hospital stay.
Stroke Impact Scale Score
Time Frame: At admission and at discharge
At admission and at discharge
Action Research Arm Test Score
Time Frame: At admission and at discharge
At admission and at discharge
Ashworth Assessment (Upper Extremity) Scores
Time Frame: At admission and at discharge
At admission and at discharge
Fugl-Meyer Assessment (Upper Extremity) Scores
Time Frame: At admission and at discharge
At admission and at discharge
Goniometric Range of Motion Evaluation, Passive and Active (Shoulder, Elbow, and Wrist)
Time Frame: At admission and at discharge
At admission and at discharge
Assessment of Active Range of Motion (Fingers, as ¼ range, ½ range, ¾ range or full range)
Time Frame: At admission and at discharge
At admission and at discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

Saebo, Inc.

Investigators

  • Principal Investigator: Elie P Elovic, M.D., Kessler Medical Rehabilitation Research & Education Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (ACTUAL)

May 1, 2006

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (ESTIMATE)

June 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2007

Last Update Submitted That Met QC Criteria

July 23, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-519-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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