FINGER Robot Therapy Study

Not Applicable

Completed

Brief Summary: The purpose of this study is to determine the effectiveness of training hand movement using FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users to play computer games using those movements.

Detailed Description: Robotic devices can be used to retrain movement after stroke. However, it is unclear how best to assist in movement. Providing physical assistance may improve the flow of proprioceptive information to the nervous system, which may help a person relearn to move a limb. On the other hand, assisting movement with a robot may cause a person to "slack", not trying as hard during therapy. This study will test the effect of different levels of assistance on recovery of finger function during robot-assisted therapy after stroke.

Recruitment & Eligibility

Inclusion Criteria

Age 18 to 80 years of age
Have history of stroke affecting the arm, at least 6 months prior to enrollment
have arm and/or hand weakness as measured on a standard clinical scale
do not have active major psychological problems, or problems affecting the stroke-affected arm or hand besides the stroke
do not have active major brain disease other than the stroke
have absence of pain in the stroke-affected arm and hand

Exclusion Criteria

severe stiffness of the arm or hand as measured on a standard clinical scale
severe problems speaking or understanding speech as measured on a standard clinical scale
severe reduced level of consciousness
severe loss ability to sense movement of your limbs as measured on a standard clinical scale
currently pregnant
difficulty in understanding or complying with the instructions given by the researcher
inability to perform the experimental task that will be studied
increased pain with movement of the stroke-affected arm or hand

Exclusion criteria that will prevent subjects from participating in the MRI:

Subjects having any implanted metal such as metallic splinters, metallic surgical clips, prosthetic heart valves, pacemakers, neuro-stimulation devices, orthodontic work that contains ferromagnetic materials,
Subjects whose occupation or activities may cause accidental lodging of ferromagnetic materials, or that may have imbedded metal fragments from military activities, unless cleared by a screening head CT scan
Subjects with tattoo(s) presenting metallic or ferromagnetic color ingredients or with facial make-up
Subjects who have claustrophobia
Subjects who are currently pregnant or breastfeeding.

Arm && Interventions

Group	Intervention	Description
FINGER II	FINGER II	Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER II	FINGER I	Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I	FINGER I	Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I	FINGER II	Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program

Primary Outcome Measures

Name	Time	Method
Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed	From baseline to 1-month post therapy	The primary endpoint was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 seconds, from baseline to 1-month post-therapy. The higher the scores, the better arm and hand function indicated.

Secondary Outcome Measures

Name	Time	Method
Motor and Strength Measure Using Action Research Arm Test Measured as a Score	From baseline to 1-month post therapy	We compared the change in Action Research Arm Test (ARAT) scores from the baseline evaluation to 1-month post-therapy evaluation. The ARAT is a 57-point scale, 0 being the minimum scoreand 57 being the maximum score, that measures upper extremity function, coordination, and dexterity. The higher scores indicate a better outcome.
Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score	From baseline to 1-month post therapy	The primary outcome measure was the change in Upper Extremity Fugl-Meyer score on a scale of 0 to 66 at one-month post-therapy. The higher the scores, the better arm and hand function indicated.