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Use of Interactive Gaming for Enhanced Function After Spinal Cord Injury

Primary Purpose

Paraplegia and Tetraplegia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Video gaming for enhanced function after spinal cord injury.
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paraplegia and Tetraplegia focused on measuring spinal cord injury, video gaming, functional improvement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Neurologic level of injury at or below cervical level 5 (C5) through C8 [tetraplegia] and at or below T1 through L3 [paraplegia]; persons with incomplete lesions at higher levels may be eligible, decided on a case by case basis depending on functional ability, Complete and incomplete injury allowed, Physical capability (ie, sufficient voluntary motor function) to participate in unassisted resistive exercise, determined as a minimum of grade 3 (by manual muscle testing) on elbow and wrist extension, Use of either a manual or power wheelchair as primary mobility, Absence of significant medical complications, Normal or nearly normal cognitive function (ie, minimal cognitive impairment may be allowed on a case by case basis), Willingness to participate for the duration of the study.

Exclusion Criteria:

Use of ambulation for mobility, Concurrently participating in any other exercise intervention or sports program, Medical condition that would interfere in gaming either short term or during extended play.

Sites / Locations

  • Va Palo Alto Health Care System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Video game play

Arm Description

Changes in upper limb; strength, active range of motion, electromyographic activity as well as heart rate response.

Outcomes

Primary Outcome Measures

Increased Electromyographic actvity of upper the upper arm with video gaming.
EMG will be measured at baseline testing for video game play and post testing after the videogaming is completed.

Secondary Outcome Measures

Increased heart rate with Video gaming
Baseline heart rate will be measured across all video games to see whcih elicit elevated hear rates consistent with appropriate exercise response.

Full Information

First Posted
February 17, 2012
Last Updated
December 8, 2014
Sponsor
VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01537978
Brief Title
Use of Interactive Gaming for Enhanced Function After Spinal Cord Injury
Official Title
Use of Interactive Gaming After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether there are functional improvements in arm muscles and movments for spinal cord injured indviduals after performing video gaming.
Detailed Description
Today, Nintendo's Wii has become integrated into our popular culture replete with its own vocabulary and marketed promise of achieving fitness through video gaming. Recently the term "Wii-habilitation" has gained popularity to represent application of interactive gaming into the therapeutic setting as a form of rehabilitation. However, this technology remains largely untested in the rehabilitation field despite seemingly widespread use. Interactive gaming may indeed contribute to an important problem in rehabilitation, especially for persons with spinal cord injury (SCI) who use manual wheelchairs for primary mobility and depend on their upper extremity for independence. Individuals with SCI will benefit tremendously by maximization of early rehabilitation post-injury and effective ongoing conditioning focused on the upper extremity through a continuum of care model that supports life-long health habits. Further, traditional exercise therapy targets components of function such as range of motion and strength, but often relies on isolated movements and repetitions which might not be the most effective method. Alternately, video interactive gaming can provide an engaging, variable, challenging, and fun activity-based approach that could enhance both adherence to exercise and functional outcomes. A video gaming system can be readily implemented in a clinical setting and affordably deployed for home use with minimal instruction, is easy to use for continuation of therapy, and is well-suited to the SCI population for whom exercise options are limited. A wide variety of activities and games are available that utilize upper extremity movements "playing" real world sports such as golf, tennis, and bowling; multiple options for play are available which add variety and contribute to a comprehensive work-out. Players must grade whole upper limb forces to play the various games paralleling a traditional exercise regimen; visual and auditory feedback add interest and fun to the sessions. Interactive gaming allows for single and multiple player options and thus lends itself readily to promotion of social engagement. Real-life scenarios may contribute to self-motivation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraplegia and Tetraplegia
Keywords
spinal cord injury, video gaming, functional improvement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video game play
Arm Type
Experimental
Arm Description
Changes in upper limb; strength, active range of motion, electromyographic activity as well as heart rate response.
Intervention Type
Other
Intervention Name(s)
Video gaming for enhanced function after spinal cord injury.
Other Intervention Name(s)
Nintendo Wii Video gaming
Intervention Description
Spinal cord injured indviduals will play Nintendo Wii sports games for an 8 week period.
Primary Outcome Measure Information:
Title
Increased Electromyographic actvity of upper the upper arm with video gaming.
Description
EMG will be measured at baseline testing for video game play and post testing after the videogaming is completed.
Time Frame
Testing session 1 - at the start of the study ("week 0"). This is called the baseline testing session.
Secondary Outcome Measure Information:
Title
Increased heart rate with Video gaming
Description
Baseline heart rate will be measured across all video games to see whcih elicit elevated hear rates consistent with appropriate exercise response.
Time Frame
Testing session 1 - at the start of the study ("week 0"). This is called the baseline testing session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Neurologic level of injury at or below cervical level 5 (C5) through C8 [tetraplegia] and at or below T1 through L3 [paraplegia]; persons with incomplete lesions at higher levels may be eligible, decided on a case by case basis depending on functional ability, Complete and incomplete injury allowed, Physical capability (ie, sufficient voluntary motor function) to participate in unassisted resistive exercise, determined as a minimum of grade 3 (by manual muscle testing) on elbow and wrist extension, Use of either a manual or power wheelchair as primary mobility, Absence of significant medical complications, Normal or nearly normal cognitive function (ie, minimal cognitive impairment may be allowed on a case by case basis), Willingness to participate for the duration of the study. Exclusion Criteria: Use of ambulation for mobility, Concurrently participating in any other exercise intervention or sports program, Medical condition that would interfere in gaming either short term or during extended play.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatrice J Kiratli, PhD
Organizational Affiliation
US Department of Veterans Affairs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Va Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

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Use of Interactive Gaming for Enhanced Function After Spinal Cord Injury

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