NCT01537978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

February 17, 2012

Last Update Submit

December 8, 2014

Conditions

Keywords

spinal cord injury, video gaming, functional improvement

Outcome Measures

Primary Outcomes (1)

  • 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.

    Testing session 1 - at the start of the study ("week 0"). This is called the baseline testing session.

Secondary Outcomes (1)

  • Increased heart rate with Video gaming

    Testing session 1 - at the start of the study ("week 0"). This is called the baseline testing session.

Study Arms (1)

Video game play

EXPERIMENTAL

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.

Interventions

Spinal cord injured indviduals will play Nintendo Wii sports games for an 8 week period.

Also known as: Nintendo Wii Video gaming
Video game play

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Va Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

ParaplegiaQuadriplegiaSpinal Cord Injuries

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Beatrice J Kiratli, PhD

    US Department of Veterans Affairs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Clinical Research Spinal Cord Injury

Study Record Dates

First Submitted

February 17, 2012

First Posted

February 23, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations