Improving Balance in TBI Using Virtual Reality
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02298231|
Recruitment Status : Unknown
Verified October 2016 by Kessler Foundation.
Recruitment status was: Recruiting
First Posted : November 21, 2014
Last Update Posted : October 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Other: Standard of Care Balance Intervention Other: Mystic Isle Balance Intervention Other: Mystic Isle Balance Intervention with Dual Task||Not Applicable|
Traumatic Brain injury (TBI) is a major health concern for the U.S. military and civilian populations, resulting in more than 5.3 million people who require rehabilitation and assistance for the short and long-term consequences of TBI. TBI impairs the integration and organization of the visual, auditory and somatosensory inputs that permit body position awareness, in relation to self and the environment. Even minor impairments in any of these systems can cause balance dysfunction (BDF), which is one of the most disabling aspects of TBI. BDF affects over 65% of all individuals with TBI. When cognitive deficits are present, BDF may become more pronounced, particularly when attempting to engage in more than one task at a time (i.e., dual task). Treating BDF in patients with TBI can be challenging, as traditional treatments do not consistently replicate everyday life environments. Virtual reality (VR) interventions enable clinicians to systematically deliver and control dynamic, interactive, multisensory stimuli. The proposed study will implement and evaluate a novel, low-cost, VR rehabilitation tool (Mystic Isle; MI) targeting somatosensory, vestibular, and vision systems through a double-blind RCT. Given the importance of dual-task skills for real-world functioning, the investigators will also evaluate the relative effectiveness of dual task (balance and cognitive) VR training to improve balance.
Preliminary case, feasibility and efficacy studies have been conducted using MI with rehabilitation populations. Findings demonstrate that customized VR using full-body movement tracking is motivating, feasible for balance training in neurorehabilitation populations, and results in improved balance and motor action planning. The proposed study will directly evaluate the effectiveness of a low-cost, interactive, multisensory, VR training using MI to improve balance and global functioning. The investigators will evaluate the relative effectiveness of dual task (balance and cognitive) VR training to improve balance, the long-term effectiveness of such training, and the utility of a balance maintenance program for facilitating longer-term treatment effects.
A total of 180 participants (Service Members, Veterans, civilians) with mild to severe TBI and documented balance impairments will be randomly assigned into one of three balance treatment groups: 1) Standard of care (control condition); 2) MI; 3) MI dual task (balance plus cognitive). All groups will undergo 2 treatment sessions/week x 6 weeks (i.e. 12 sessions). Following completion of the treatment protocol, participants in the MI training group will be randomly assigned to a maintenance training group (2 sessions/month x 4 months) or a non-maintenance group. All participants will undergo baseline, immediate (6 weeks), and long-term (4 months) follow-up assessments of: 1) static and dynamic balance and 2) community integration, self-efficacy, quality of life, and cognitive function. This design will allow us to assess the efficacy of MI as a customizable balance treatment in TBI, and to evaluate the impact of this remediation program on overall functioning.
The following hypotheses are proposed: 1) Participants completing both MI training conditions will exhibit significantly improved balance relative to the control group; 2) Participants completing both MI training conditions will demonstrate significantly greater improvements in global functioning relative to the control group; 3) Participants receiving the MI dual task training (balance and cognitive) will exhibit significantly greater improvements in balance relative to those in the single task MI training; 4) Participants completing both MI training conditions will sustain treatment gains for up to 4 months following treatment relative to baseline performance; the control group will maintain or decrease balance between follow-up sessions; and 5) Participants receiving maintenance training will maintain better balance over the 4 month follow-up period compared to the non-maintenance group.
The proposed study is poised to make an important contribution to enhancing balance function in service members and civilians with TBI, thereby promoting recovery of physical and social functioning and overall quality of life.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Improving Balance in TBI Using a Low-Cost Customized Virtual Reality Rehabilitation Tool|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: Group 1
Standard of Care Balance (SCB) Treatment
Other: Standard of Care Balance Intervention
Standard balance therapy as performed by a physical therapist
Experimental: Group 2
Mystic Isle (MI) Balance Training
Other: Mystic Isle Balance Intervention
Balance therapy using virtual reality
Experimental: Group 3
Mystic Isle (MI) Dual Task Training
Other: Mystic Isle Balance Intervention with Dual Task
Balance therapy using virtual reality and performing cognitive tasks
- Balance Assessment [ Time Frame: 4 months ]Physical tasks scored based on performance, e.g., 10 Meter walk, Balance Tasks and Computerized Sensory Organization Test
- Global Functioning evaluating the impact of the intervention on everyday life [ Time Frame: 4 months ]Questionnaires
- Neuropsychological Assessment examining changes in cognitive functioning [ Time Frame: 4 months ]Questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298231
|Contact: Kathleen Goworek||973-324-3560 ext email@example.com|
|Contact: Lea Frank||973-324-3581 ext firstname.lastname@example.org|
|United States, New Jersey|
|West Orange, New Jersey, United States, 07052|
|Contact: Kate Chervin 973-324-3560 ext 3560 email@example.com|
|Principal Investigator:||Karen J Nolan, PhD||Kessler Foundation|
|Principal Investigator:||Denise Krch, PhD||Kessler Foundation|