WiiMote Game Controller as a Device to Study Movement Disorders

Parkinson Disease Clinical Trial

Official title:

WiiMote Game Controller as a Device to Study Movement Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00802191
• Other study ID #: TDavis Wii
• Status: Terminated
• Phase: N/A
• First received: December 2, 2008
• Last updated: August 29, 2014
• Start date: August 2007
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: August 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Essential Tremor
• Movement Disorders
• Parkinson Disease

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	National Parkinson Foundation, Robertson County Parkinson Support Group

Country where clinical trial is conducted

United States,