Traumatic Brain InjuryNCT02298231
Improving Balance in TBI Using Virtual Reality
A study testing Mystic Isle Balance Intervention and Mystic Isle Balance Intervention with Dual Task in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
This research study evaluates the effectiveness of a low-cost Virtual Reality-based (VR) training system in providing a customized balance treatment in a skilled clinical setting. Participants will be assigned to one of three treatment groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Mystic Isle Balance Intervention and Mystic Isle Balance Intervention with Dual Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with a mild to severe Traumatic Brain Injury (TBI). My TBI severity will be categorized by research study staff based on length of loss of consciousness (LOC), alteration of consciousness/mental state (AOC) or post-traumatic amnesia (PTA).
- Must be out of PTA, as indicated by O-log score of > 24 on 2 consecutive days as determined by study staff.
- Be at least 3 months post injury.
- Speak English.
- As determined by study personnel, have at least 20/60 acuity in worst eye according to the Snellen Eye Exam.
- As determined by study personnel, receive an acceptable score on the Token Test.
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- Balance dysfunction as determined by impairment on standing balance measures (Sensory Organization Test)
- Be able and willing to comply with study procedures, including follow-up requirements.
- Be willing and able to give informed consent
Who cannot join
- Have an unstable or uncontrolled seizure disorder.
- Have a diagnosis of excessive fluid surrounding my brain.
- Have severe cardiac disease (e.g. heart attack or heart failure).
- Have uncontrolled or unstable orthostatic hypotension (blood pressure drops suddenly when one stands, causing one to feel light headed or dizzy).
- Have had a lower limb injury in the past 90 days.
- Have any other injury that affects one's ability to balance.
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- Have a pre-existing condition that significantly affects one's alignment or function of one's lower limb while standing.
- Be on any medication that may affect one's balance, strength, or muscle coordination (e.g. Botox, Baclofen).
- Have significant neurological history (e.g.epilepsy that began before TBI, multiple sclerosis) other than TBI.
- Have significant psychiatric history (i.e. schizophrenia).
- Have a history of significant drug abuse.
- Have had physical or occupational therapy or treatment for balance disorder in the past 30 days.
- Have difficulty following or responding to commands that would limit study participation.
- Be currently enrolled in another research study that is likely to affect participation in this research study.
- Have any underlying medical conditions that would limit study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Kate Chervin, 973-324-3560 ext. 3560, kgoworek@kesslerfoundation.org
About this study
Official title: Improving Balance in TBI Using a Low-Cost Customized Virtual Reality Rehabilitation Tool
This research study evaluates the effectiveness of a low-cost Virtual Reality-based (VR) training system in providing a customized balance treatment in a skilled clinical setting. Participants will be assigned to one of three treatment groups.
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Standard of Care Balance Intervention, Mystic Isle Balance Intervention, Mystic Isle Balance Intervention with Dual Task
- Keywords
- Traumatic Brain Injury, Balance, TBI, Veterans, Virtual Reality
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Balance InterventionOther
Standard balance therapy as performed by a physical therapist
Mystic Isle Balance InterventionOther
Balance therapy using virtual reality
Mystic Isle Balance Intervention with Dual TaskOther
Balance therapy using virtual reality and performing cognitive tasks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Standard of Care Balance (SCB) Treatment Receives: Other: Standard of Care Balance Intervention |
| Group 2 | Experimental | Mystic Isle (MI) Balance Training Receives: Other: Mystic Isle Balance Intervention |
| Group 3 | Experimental | Mystic Isle (MI) Dual Task Training Receives: Other: Mystic Isle Balance Intervention with Dual Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Assessment
Physical tasks scored based on performance, e.g., 10 Meter walk, Balance Tasks and Computerized Sensory Organization Test
Measured: 4 months
Secondary outcomes (2)
Global Functioning evaluating the impact of the intervention on everyday life
Questionnaires
Measured: 4 months
Neuropsychological Assessment examining changes in cognitive functioning
Questionnaires
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startApr 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Fort Belvoir Community Hospital, University of Southern California, VA Office of Research and Development, Kessler Institute for Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Karen J Nolan, PhD, Principal investigator, Kessler FoundationDenise Krch, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298231
- Sponsor's protocol ID
- R-831-14
- Status last verified
- Oct 2016
- First submitted
- 5 Nov 2014
- Last updated
- 14 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Balance in TBI Using a Low-Cost Customized Virtual Reality Rehabilitation Tool
- ClinicalTrials.gov ID
- NCT02298231
- Acronym / sponsor ID
- R-831-14
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Balance, TBI, Veterans, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Fort Belvoir Community Hospital, University of Southern California, VA Office of Research and Development, Kessler Institute for Rehabilitation
- Study start
- Apr 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study evaluates the effectiveness of a low-cost Virtual Reality-based (VR) training system in providing a customized balance treatment in a skilled clinical setting. Participants will be assigned to one of three treatment groups.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Standard of Care Balance InterventionStandard of Care Balance (SCB) Treatment |
| Group 2 | Experimental | Other: Mystic Isle Balance InterventionMystic Isle (MI) Balance Training |
| Group 3 | Experimental | Other: Mystic Isle Balance Intervention with Dual TaskMystic Isle (MI) Dual Task Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have been diagnosed with a mild to severe Traumatic Brain Injury (TBI). My TBI severity will be categorized by research study staff based on length of loss of consciousness (LOC), alteration of consciousness/mental state (AOC) or post-traumatic amnesia (PTA).
- Must be out of PTA, as indicated by O-log score of > 24 on 2 consecutive days as determined by study staff.
- Be at least 3 months post injury.
- Speak English.
- As determined by study personnel, have at least 20/60 acuity in worst eye according to the Snellen Eye Exam.
Key exclusion criteria (15 listed)
- Have an unstable or uncontrolled seizure disorder.
- Have a diagnosis of excessive fluid surrounding my brain.
- Have severe cardiac disease (e.g. heart attack or heart failure).
- Have uncontrolled or unstable orthostatic hypotension (blood pressure drops suddenly when one stands, causing one to feel light headed or dizzy).
- Have had a lower limb injury in the past 90 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care Balance InterventionStandard balance therapy as performed by a physical therapist | Other | Group 1 |
| Mystic Isle Balance InterventionBalance therapy using virtual reality | Other | Group 2 |
| Mystic Isle Balance Intervention with Dual TaskBalance therapy using virtual reality and performing cognitive tasks | Other | Group 3 |
Primary outcome
Balance Assessment
Time frame: 4 months
Physical tasks scored based on performance, e.g., 10 Meter walk, Balance Tasks and Computerized Sensory Organization Test
2 secondary outcomes
Global Functioning evaluating the impact of the intervention on everyday life
Time frame: 4 months
Neuropsychological Assessment examining changes in cognitive functioning
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen J Nolan, PhD principal investigator
Kessler Foundation
Denise Krch, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mystic Isle Balance Intervention and Mystic Isle Balance Intervention with Dual Task in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Goworek (973-324-3560 ext. 3560, kgoworek@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Assessment (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016; AzTrials last refreshed its copy on 2 Nov 2026.