Clinical trial NCT02048826: FINGER Robot Therapy Study
Official title: Study of Influence of Timing on Motor Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: stroke
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed
timeFrame: From baseline to 1-month post therapy
Secondary outcomes:
measure: Motor and Strength Measure Using Action Research Arm Test Measured as a Score
timeFrame: From baseline to 1-month post therapy
measure: Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score
timeFrame: From baseline to 1-month post therapy
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: David Reinkensmeyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingemanson ML, Rowe JR, Chan V, Wolbrecht ET, Reinkensmeyer DJ, Cramer SC. Somatosensory system integrity explains differences in treatment response after stroke. Neurology. 2019 Mar 5;92(10):e1098-e1108. doi: 10.1212/WNL.0000000000007041. Epub 2019 Feb 6.