FINGER Robot Therapy Study

Cerebrovascular Accident Clinical Trial

Official title:

Study of Influence of Timing on Motor Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048826
• Other study ID #: HS#2008-6432
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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.

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Device:
• FINGER I
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
• FINGER II
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed	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.	From baseline to 1-month post therapy
Secondary	Motor and Strength Measure Using Action Research Arm Test Measured as a Score	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.	From baseline to 1-month post therapy
Secondary	Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score	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.	From baseline to 1-month post therapy