FINGER Robot Therapy Study

University of California Irvine (UCI)

Status: Completed

Conditions: Cerebrovascular Accident

Treatments: Device: FINGER I; Device: FINGER II

Study type: Interventional

Funder types: Other

Identifiers

NCT02048826

HS#2008-6432

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups

FINGER I

Experimental group

Description:

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

Treatment:

Device: FINGER I

Device: FINGER II

FINGER II

Experimental group

Description:

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

Treatment:

Device: FINGER I

Device: FINGER II