WiiMote Game Controller as a Device to Study Movement Disorders

This study has been terminated.
(Lack of study participants, no data published.)
Sponsor:
Collaborators:
National Parkinson Foundation
Robertson County Parkinson Support Group
Information provided by (Responsible Party):
Thomas L Davis, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00802191
First received: December 2, 2008
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

Purpose of the study:

The purpose of this study is to investigate the Wii remote game control device for use in the study of Movement Disorders. The term "Movement Disorders" refers to a group of abnormal medical conditions characterized by involuntary body movements. Current treatment of these disorders is primarily geared to improve symptoms. Rating scales are usually used to grade response to treatment. These rating scales require special training, take a lot of time, and often present with great variability. Thus, the development of a simple device to perform efficacy measurements offers a great advantage over current methods and is less costly.


Condition
Parkinson Disease
Essential Tremor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: WiiMote Game Controller as a Device to Study Movement Disorders

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Enrollment: 250
Study Start Date: August 2007
Study Completion Date: August 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control Group
Participants with no movement disorders.
Movement Disorders Participants
Participants have a movement disorder

Detailed Description:

The expected length of taking part in this study will depend on whether or not subjects are chosen for a group to look at the reproducibility of the data collected from the Wii remote. If subjects agree to take part in the study, basic data including age, gender, ethnicity, and medications will be collected. If subjects have been diagnosed with a movement disorder, that diagnosis will also be recorded. This data will be secured in a HIPAA compliant computer system and recorded data will be given a unique random code. During the Wii remote portion of the study, subjects will be asked to hold the Wii remote controller in several different positions and perform various movements with the controller.

These include:

  1. Holding the controller still with the elbow straight and then the elbow bent.
  2. Tapping the control button as fast as you can.
  3. Rotation of your wrist as fast as you can.
  4. Bending at the wrist and at the elbow as fast as you can.
  5. Walking 30 feet.
  6. Attaching the controller to your arm with a Velcro strap and repeating the motions performed while holding the controller.

These maneuvers will be done first with the right and then the left hand. We expect that this series will take about 5 minutes.

If subjects have Parkinson's disease they will also be asked to undergo Part III (Motor Sub-Scale) of the Unified Parkinson's Disease Rating Scale. This scale measures various aspects such as finger tapping, hand opening and closing and walking on a scale of 0 - 4. We expect that this portion of the examination will take about 5 minutes.

If subjects carry the diagnosis of Essential Tremor, they will be asked to undergo Standard Measure of EssentialTremor that includes drawing of spirals and pouring of water from one glass to another. Again, we estimate that this scale will take about 5 minutes.

If subjects carry the diagnosis of Parkinson's disease or Essential Tremor and have deep brain stimulation surgery, results of using the Wii™ Remote game controller (handheld or attached using a Velcro strap) will be done during a clinical programming appointment. The information obtained will not be used for any clinical use and will not interfere with the normal standard of care.

A sub-set of patients will be asked to repeat these measures at various times to see if there is either a learning curve, or if the measures are repeatable over time. Subjects may decline this at any point in time.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

18 Years and older, females of childbearing potential, healthy volunteers and adults with movement disorders.

Criteria

Inclusion Criteria:

  1. Men and women, aged 18 or older, with abnormal movements (including tremor, chorea, dystonia, myoclonus, and tic) and normal controls (subjects without abnormal movements).
  2. Subjects must be willing and able to comply with study procedures.
  3. Patients must be willing and able to give meaningful, written informed consent.

Exclusion Criteria:

1. Significant cognitive impairment which, in the opinion of the Investigator, would interfere with the ability to complete all the tests required in the protocol.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802191

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2551
Sponsors and Collaborators
Vanderbilt University
National Parkinson Foundation
Robertson County Parkinson Support Group
Investigators
Principal Investigator: Thomas L Davis, MD Department of Neurology/Movement Disorders
  More Information

No publications provided

Responsible Party: Thomas L Davis, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00802191     History of Changes
Other Study ID Numbers: TDavis Wii
Study First Received: December 2, 2008
Last Updated: August 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Movement Disorders
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 22, 2014