EFFECTS OF THE SAEBOFLEX® ORTHOSIS AND A HOME EXERCISE PROGRAM ON UPPER EXTREMITY RECOVERY IN INDIVIDUALS WITH CHRONIC (2006)

Purpose/Hypothesis: The SaeboFlex® is a dynamic orthosis that assists an individual who cannot grasp and release an object to open their hand. There is no literature on the effectiveness of the SaeboFlex®. The SaeboFlex® may help an individual with severe upper extremity (UE) involvement improve and ultimately qualify for Constraint-Induced Therapy (CIT) whose protocol has minimum motor criteria of active finger and wrist extension. Research has shown that CIT can improve arm function after stroke. The purpose of this pilot study was to examine the effects of the SaeboFlex® and a home exercise program (HEP) on the UE recovery of individuals with chronic hemiparesis who do not qualify for CIT. Number of Subjects: 5 subjects post-stroke (mean = 5.98 yrs post; 1 woman and 4 men) with hemiparesis began the study (mean age = 58.2 yrs). All were right-handed, 3 exhibited right and 2 left hemiparesis. One subject withdrew during the study without posttest measures due to conflicts with work/travel schedule. Materials/Methods: A single-group pretest-posttest design was used. Each subject was measured and fitted with a SaeboFlex® which was loaned to them by Saebo, Inc. for the 6-week intervention. The day of the fitting a caregiver and the subject were instructed on application of the SaeboFlex® and a HEP. Intervention consisted of wearing the SaeboFlex® while performing a HEP of grasp and release activities for 45 minutes, twice daily. The subjects were followed weekly to check the fit of the brace and review HEP compliance. Outcome measures included: Action Research Arm Test (ARAT), grip strength with a dynamometer, wrist extension passive ROM and wrist and finger extension manual muscle test (MMT). Grip strength and ROM were analyzed using a paired t test. The ARAT and MMT were analyzed using a Wilcoxon signed rank test. Results: The results of this pilot study showed a statistically significant increase in grip strength with a mean increase of 4.62 lbs. (p = .05). Wrist extension ROM showed trends toward improvement with a mean increase of 6.25 degrees (p = .06). Other outcome measures did not reach statistical significance: ARAT score mean increase was 3.75 points (p = .14), wrist extension and finger extension MMT increased an average of 1.33 grades (p = .14) and 0.75 grades (p = .18) respectively. Conclusions: Results from this pilot study seem to indicate improved grip strength and trends for improved wrist extension ROM following the use of the SaeboFlex® and HEP in individuals with chronic hemiparesis. This pilot study did not find significant improvements in UE function or finger or wrist extension strength. The pilot study results support the need for further research on the effectiveness of the SaeboFlex®. Clinical Relevance: The SaeboFlex® may be effective in helping an individual with hemiplegia and severe UE involvement begin to succeed with grasp and release activities and then qualify for CIT protocols. However, more research is needed with larger sample sizes, control groups and various intensities of intervention.