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

Completed · Not applicable

Conditions studied: Stroke, Hemiplegia

In brief

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.

Key facts

Study ID

NCT00489580

Run by

Kessler Foundation

People needed

24

Starts

2005-08-01

Expected to finish

2006-05-01

Last updated by the study team

2007-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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