Use of Interactive Gaming for Enhanced Function After Spinal Cord Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by VA Palo Alto Health Care System.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Beatrice Jenny Kiratli PhD, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT01537978
First received: February 17, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Paraplegia and Tetraplegia
Other: Video gaming for enhanced function after spinal cord injury.
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Use of Interactive Gaming After Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Increased Electromyographic actvity of upper the upper arm with video gaming. [ Time Frame: Testing session 1 - at the start of the study ("week 0"). This is called the baseline testing session. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Testing session 1 - at the start of the study ("week 0"). This is called the baseline testing session. ] [ Designated as safety issue: No ]
    Baseline heart rate will be measured across all video games to see whcih elicit elevated hear rates consistent with appropriate exercise response.


Estimated Enrollment: 15
Study Start Date: February 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Video game play
Changes in upper limb; strength, active range of motion, electromyographic activity as well as heart rate response.
Other: Video gaming for enhanced function after spinal cord injury.
Spinal cord injured indviduals will play Nintendo Wii sports games for an 8 week period.
Other Name: Nintendo Wii 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  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: NCT01537978

Contacts
Contact: Jeff Jaramillo, MSPT 650-493-5000 ext 62286 jeffrey.jaramillo@va.gov
Contact: Daniel Fong, BS 650-493-5000 ext 69323 daniel.fong3@va.gov

Locations
United States, California
Va Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Jeff Jaramillo, MSPT    650-493-5000 ext 62286    Jeffrey.jaramillo@va.gov   
Principal Investigator: Jenny Kiratli, PhD         
Sponsors and Collaborators
VA Palo Alto Health Care System
Investigators
Principal Investigator: Beatrice J Kiratli, PhD Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Beatrice Jenny Kiratli PhD, Director Clinical Research Spinal Cord Injury, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01537978     History of Changes
Other Study ID Numbers: 18834
Study First Received: February 17, 2012
Last Updated: February 17, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Palo Alto Health Care System:
spinal cord injury, video gaming, functional improvement

Additional relevant MeSH terms:
Spinal Cord Injuries
Paraplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014