FINGER Robot Therapy Study

March 23, 2021 updated by: David Reinkensmeyer, University of California, Irvine

Study of Influence of Timing on Motor Learning

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Device: 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
Experimental: 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
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
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed
Time Frame: 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.
From baseline to 1-month post therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor and Strength Measure Using Action Research Arm Test Measured as a Score
Time Frame: 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.
From baseline to 1-month post therapy
Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score
Time Frame: 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.
From baseline to 1-month post therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: David Reinkensmeyer, PhD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS#2008-6432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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