A Pilot Study Investigating the Feasibility of the Saebo Arm Training Program on an Inpatient Population
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|ClinicalTrials.gov Identifier: NCT00489580|
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : July 25, 2007
- 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.
- To compare functional improvements in hand and UE use achieved with the F.T.M. program as compared to generally applied therapeutic treatment approaches.
- To develop recommendations for an inpatient retraining protocol that could then be evaluated in a multi-center trial.
- 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.
|Condition or disease||Intervention/treatment|
|Stroke Hemiplegia||Device: SaeboFlex Dynamic Hand Orthosis Procedure: Saebo F.T.M. Arm Training Program|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||August 2005|
|Study Completion Date :||May 2006|
- Hand grip strength (measured using dynamometry) [ Time Frame: At admission and at discharge ]
- Length of Stay (days) [ Time Frame: The duration of the subject's inpatient hospital stay. ]
- Stroke Impact Scale Score [ Time Frame: At admission and at discharge ]
- Action Research Arm Test Score [ Time Frame: At admission and at discharge ]
- Ashworth Assessment (Upper Extremity) Scores [ Time Frame: At admission and at discharge ]
- Fugl-Meyer Assessment (Upper Extremity) Scores [ Time Frame: At admission and at discharge ]
- Goniometric Range of Motion Evaluation, Passive and Active (Shoulder, Elbow, and Wrist) [ Time Frame: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489580
|United States, New Jersey|
|Kessler Institute for Rehabilitation|
|East Orange, New Jersey, United States, 07018|
|Principal Investigator:||Elie P Elovic, M.D.||Kessler Medical Rehabilitation Research & Education Center|