Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton

After stroke, individuals often have great difficulty with using the affected hand in
functional tasks. The hand frequently suffers from finger flexor hypertonia as well as finger
extensor weakness. This leads to increased difficulty in grasp and release of objects.
HandSOME is a light weight wearable hand orthosis that increases range of motion and
decreases effort during grasping tasks. The goal of this study is to evaluate the HandSOME
device's effectiveness in the rehabilitation of stroke patients through an 8 week
intervention. Eligible subjects will use the device daily at home for 8 weeks with one visit
per week to the clinic to evaluate progress and troubleshoot problems with the device. The
hypotheses are that the gains from the 8 weeks of training will be statistically significant
and clinically important (defined as gains of greater than 10% of full scale) in the domains
of impairment, function and amount of arm use.

Inclusion Criteria:

1. Diagnosis of stroke more than six months prior to entry into the study

2. Impaired ability to open affected the hand

3. At least trace ability to extend the wrist and fingers

Exclusion Criteria:

1. Have cognitive deficits that could negatively affect their ability to complete the
protocols as evidenced by a score of 24 or less on the Folstein Mini-Mental State
Examination

2. Have excessive pain in any joint of the affected extremity that could limit ability to
cooperate with the protocols

3. Have serious uncontrolled medical problems as judged by the project therapist

4. Receiving oral or injected antispasticity medications during study treatment

5. MCP and IP passive extension limit > 30 degrees from full extension

6. Excessive tone in the fingers and thumb as determined by Ashworth scores >=3