NCT06473987 · Kessler Foundation
Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance
(CMT)
What this study is about
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.
View original scientific description
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. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/augmented reality (AR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training after a brain injury. The study will evaluate the differences between three intervention groups (n=45 each): 1) personalized cognitive integrated sensorimotor VR/AR training (CMT), 2) traditional dual-task training (CTRL), and 3) standard of care (SOC) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CMT.
Interventions
OTHER
Personalized cognitive-sensorimotor VR/AR training
Thinking task integrated walking and balance training program
OTHER
Traditional dual-task training
Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training
OTHER
Standard of Care
Standard walking and balance training
Primary outcome measures
10 Meter walk test
Time frame: 10 weeks
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Timed Up and Go (TUG)
Time frame: 10 weeks
TUG is a clinical test of functional gait abilities and dynamic balance. The participants will be asked to walk a distance of 3 meters from a seated position, turn around, walk back to the chair and sit back in the chair. The time taken to perform the task will be recorded using a stop watch. The TUG will be repeated multiple times. The participant may be asked to hold a plastic cup or count backwards by three from a randomly selected number while walking.
Berg balance Assessment:
Time frame: 10 weeks
This is a test that measures balance on a 5-point during routine tasks. The participant will be asked to perform 14 tasks involving: sitting, standing, reaching, lifting, and turning.
Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])
Time frame: 10 weeks
This test assesses attention and working memory.
Flanker Inhibitory Control and Attention Test
Time frame: 10 weeks
This test assesses the allocation of limited attentional capacities to deal with an abundance of environmental stimulation. The test measures attention and the ability to inhibit response that may interfere with the ability to achieve goals.
Symbol Digit Modalities Test (SDMT)
Time frame: 10 weeks
This test assesses processing speed without a motor component
Paced Auditory Serial Addition Test (PASAT)
Time frame: 10 weeks
This test assesses information processing speed \& ability and working memory
Letter-Number Sequencing (WAIS-IV)
Time frame: 10 weeks
This test assesses working memory
Delis-Kaplan Executive Function System
Time frame: 10 weeks
Selected subtests to assess executive function.
Hopkins Verbal Learning Test Revised
Time frame: 10 weeks
This test assesses acquisition and delayed recall of verbal information.
Temporal and spatial characteristics
Time frame: 10 weeks
This test assess gait deviations and symmetry
Fall Risk
Time frame: 10 weeks
The silver index will be measured using the Hunova (Movendo Srl., Italy) to quantify the risk of falls. The Silver Index tasks include static balance while eyes are open or closed, dynamic balance while standing on passive and elastic surfaces, limits of stability, reactive balance during perturbations, 6-meter walk, and sit-to-stand.
Balance
Time frame: 10 weeks
Root-mean-square of COM and COP displacements will be used to quantify static and dynamic balance during Silver Index tasks. COP will be obtained from Hunova. Whole body COM will be obtained using motion capture.
Neurophysiological- Maximum increase in O2Hb concentration in cortical regions
Time frame: 10 weeks
The change in the hemoglobin concentration in response to a metabolic event (neuronal) such as walking is known as the hemodynamic response (HDR) of the brain. The maximum increase following a task will be quantified as net cortical responsivity to task using functional near infrared spectroscopy (fNIRS)
Participation Objective, Participation Subjective (POPS)
Time frame: 10 weeks
POPS assesses perspectives of the respondent regarding participation in home \& community, and societal/normative ("outsider") evaluation. POPS consists of 26 items sorted into 5 categories \[a) Domestic Life, b) Major Life Activities, c) Transportation, d) Interpersonal Interactions and Relationships, e) Community, Recreational and Civic Life\].
Quality of Life after Brain Injury (QOLIBRI)
Time frame: 10 weeks
This assesses QoL in people with TBI and is a 37-item scale with six subscales. The first part assesses "satisfaction level" with Health-related Quality of Life (HRQOL) and is composed of 6 overall items and 29 items assigned to 4 subscales: a) thinking, b) feelings and emotion, c) autonomy in daily life, and d) social aspects. The second part is devoted to "bothered" questions and composed of 12 items in 2 subscales: a) negative feelings, and b) restrictions. Responses to the 'satisfaction' items are coded on a 1 to 5 scale, where 1= "not at all satisfied" and 5= "very satisfied". Responses to the 'bothered' items are reverse scored to correspond with the satisfaction items, where 1=" very bothered" and 5= "not at all bothered".
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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.
Exclusion criteria
- 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.
Where
- West Orange, New Jersey
Collaborators
Massachusetts General Hospital
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 27, 2024 · Source of record for eligibility and locations