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New treatment option for Traumatic Brain Injury
Official title Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance
ClinicalTrials.gov ID: NCT06473987
What this study is testing
- What it's testing
- Problems with walking and balance are common after traumatic brain injury (TBI). Walking and balance problems limit independence and increase risk for injuries due to falls.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Be between 18-65 years of age.
- Be a person living with TBI for at least 6 months.
- Be able to follow directions and commands.
- Be able to speak and understand English well as evaluated by a test I will be given by the researchers.
- Not have amnesia (as determined by study staff based on a Post Traumatic Amnesia O-log score of \> 20 on 2 consecutive days)
You likely can't join if
- I have uncontrolled or unstable seizure disorder (such as epilepsy).
- I have pre-existing condition that makes it difficult for me to exercise (such as diagnosed high blood pressure that is not controlled, heart...
- I have muscle or nervous system problems other than TBI (such as spinal cord injury, multiple sclerosis, or Parkinson's disease)
- Have any joint or muscle tightness that would limit my movement while walking.
- I have any medical issue that prevents me from supporting my weight (such as bone or muscle injuries, pain, or severe muscle spasms).
- I have been diagnosed with cognitive (thinking) problems prior to TBI.
See the full eligibility criteria
- Be between 18-65 years of age.
- Be a person living with TBI for at least 6 months.
- Be able to follow directions and commands.
- Be able to speak and understand English well as evaluated by a test I will be given by the researchers.
- Not have amnesia (as determined by study staff based on a Post Traumatic Amnesia O-log score of \> 20 on 2 consecutive days)
- Have approval from a physician to participate.
- Have no history of injury or problems with my legs in the past 6 months or any medical issue which would interfere with my ability to bear weight on my legs and walk (such as a bone or muscle injury).
- No double vision (diplopia) or other vision problems (such as nystagmus, as determined by study staff)
- Have joint passive range of motion within normal functional limits for walking as determined by study staff.
- Have a walking speed of less than 0.8 m/s as determined by study staff.
- Be able to stand for 5 minutes.
- I have uncontrolled or unstable seizure disorder (such as epilepsy).
- I have pre-existing condition that makes it difficult for me to exercise (such as diagnosed high blood pressure that is not controlled, heart disease, irregular heart rate or rhythm, or congestive heart failure).
- I have muscle or nervous system problems other than TBI (such as spinal cord injury, multiple sclerosis, or Parkinson's disease)
- Have any joint or muscle tightness that would limit my movement while walking.
- I have any medical issue that prevents me from supporting my weight (such as bone or muscle injuries, pain, or severe muscle spasms).
- I have been diagnosed with cognitive (thinking) problems prior to TBI.
- I have severe dizziness (Dizziness Handicap Inventory score greater than 54 (as measured by study staff).
- I have skin issues that would prevent me from wearing a safety harness.
The study team makes the final eligibility decision.
Where it's taking place
- West Orange, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Orange, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.