Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance
CMT
2 other identifiers
interventional
135
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 29, 2028
November 27, 2024
September 1, 2024
3.7 years
June 19, 2024
November 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (16)
10 Meter walk test
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
10 weeks
Timed Up and Go (TUG)
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.
10 weeks
Berg balance Assessment:
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.
10 weeks
Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])
This test assesses attention and working memory.
10 weeks
Flanker Inhibitory Control and Attention Test
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.
10 weeks
Symbol Digit Modalities Test (SDMT)
This test assesses processing speed without a motor component
10 weeks
Paced Auditory Serial Addition Test (PASAT)
This test assesses information processing speed \& ability and working memory
10 weeks
Letter-Number Sequencing (WAIS-IV)
This test assesses working memory
10 weeks
Delis-Kaplan Executive Function System
Selected subtests to assess executive function.
10 weeks
Hopkins Verbal Learning Test Revised
This test assesses acquisition and delayed recall of verbal information.
10 weeks
Temporal and spatial characteristics
This test assess gait deviations and symmetry
10 weeks
Fall Risk
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.
10 weeks
Balance
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.
10 weeks
Neurophysiological- Maximum increase in O2Hb concentration in cortical regions
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)
10 weeks
Participation Objective, Participation Subjective (POPS)
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 \[a) Domestic Life, b) Major Life Activities, c) Transportation, d) Interpersonal Interactions and Relationships, e) Community, Recreational and Civic Life\].
10 weeks
Quality of Life after Brain Injury (QOLIBRI)
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".
10 weeks
Secondary Outcomes (9)
6 Minute Walk Test
10 weeks
Dynamic Gait Index (DGI)
10 weeks
Walking While Talking Test
10 weeks
Area under the curve (AOC)
10 weeks
minimum change in O2Hb
10 weeks
- +4 more secondary outcomes
Study Arms (3)
Personalized cognitive-sensorimotor VR/AR training
EXPERIMENTALThinking task integrated walking and balance training program
Traditional dual-task training
ACTIVE COMPARATORWalking and balance training similar to standard of care group but will also perform additional thinking tasks during training.
Standard of Care
ACTIVE COMPARATORStandard walking and balance training
Interventions
Thinking task integrated walking and balance training program
Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training
Standard walking and balance training
Eligibility Criteria
You may qualify 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)
- 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.
You may not qualify 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kessler Foundationlead
- Massachusetts General Hospitalcollaborator
Study Sites (1)
Kessler Foundation
West Orange, New Jersey, 07052, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kiran K Karunakaran, PhD
Kessler Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single-blind randomized clinical trial
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2024
First Posted
June 25, 2024
Study Start
December 1, 2024
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
September 29, 2028
Last Updated
November 27, 2024
Record last verified: 2024-09