Completed
Home-Based Virtual Reality (VR) Treatment for Chronic Balance Problems in Adults With Traumatic Brain Injury
What is being tested
Virtual Reality Based Exercise
+ Standard Exercise
Behavioral
Who is being recruted
Brain Diseases+5
+ Brain Injuries
+ Central Nervous System Diseases
From 18 to 64 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: April 2013
Summary
Principal SponsorCraig Hospital
Last updated: February 6, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.The purpose of this study is to evaluate the effectivenes of a home-based physical therapy program designed to improve balance following traumatic brain injury by incorporating the use of a virtual reality system.
Principal SponsorCraig Hospital
Last updated: February 6, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
62 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 64 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Brain DiseasesBrain InjuriesCentral Nervous System DiseasesCraniocerebral TraumaNervous System DiseasesWounds and InjuriesTrauma, Nervous SystemBrain Injuries, Traumatic
Criteria
11 inclusion criteria required to participate
Has sustained a documented TBI that required an inpatient rehabilitation program
ambulates independently within the home (with assistive devices and/or orthotics as needed)
completes a 15 minute trial using a VR system in the absence of a negative physical or behavioral reaction
has active range of motion of bilateral upper extremities of at least 90 degrees of abduction to allow for control of the VR system
Show More Criteria
11 exclusion criteria prevent from participating
has a history of another medical illness or neurological disorder which may affect balance
has a history of psychiatric disorder requiring hospitalization
has cognitive impairment that precludes completion of baseline testing
has experienced a seizure within the last year
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center