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Completed

NCT Number: NCT02048826

FINGER Robot Therapy Study

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.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine

Irvine, California, 92697, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FINGER I

Device

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

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Study of Influence of Timing on Motor Learning

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jan 29, 2014
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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