A Pilot Study Investigating the Feasibility of the Saebo Arm Training Program on an Inpatient Population
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Status:
This study has been completed.
Purpose:
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.
Interventions:
SaeboFlex
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.
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Year Started:
2005
Year Finished:
2006
Design:
Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
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.
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.
Primary Outcome:
Hand grip strength (measured using dynamometry)
Secondary Outcome:
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).
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 9/23/2009
Reviewed on: 09/28/2009.
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