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Augmented Reality and Treadmill Training After Traumatic Brain Injury

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04553848
Recruitment Status : Not yet recruiting
First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Candace Tefertiller, Craig Hospital

Tracking Information
First Submitted Date  ICMJE September 3, 2020
First Posted Date  ICMJE September 18, 2020
Last Update Posted Date September 18, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
Community Balance and Mobility Scale [ Time Frame: Baseline to Week 8 ]
13 activities scored from 0-96, higher numbers reflect greater balance
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • 10 meter walk test [ Time Frame: Baseline, Week 4, and Week 8 ]
    total time to walk 10 meters
  • 6 minute walk test [ Time Frame: Baseline, Week 4, and Week 8 ]
    distance walked in 6 minutes
  • Timed Up and Go [ Time Frame: Baseline, Week 4, and Week 8 ]
    received verbal instructions to stand up from chair, walk 3 meters, cross a line marked on the floor, turn around, walk back and sit down
  • Timed Up and Go Cognitive Test [ Time Frame: Baseline, Week 4, and Week8 ]
    receive verbal instructions to stand up from a chair, walk 3 meters, cross a line marked on the floor, turn around, walk back and sit down while counting backward by threes from a randomly selected number between 20 and 100
  • Timed Up and Go Manual [ Time Frame: Baseline, Week 4, and Week 8 ]
    receive verbal instructions to stand up from a chair, walk 3 meters as quickly and safely as possible, cross a lined marked on the floor, turn around, walk back and sit down while holding a cup filled with water
  • Activities-Specific Confidence Scale [ Time Frame: Baseline, Week 4, and Week 8 ]
    16 item measure, scored from 0 to 100. Higher scores reflect great confidence of task
  • CNS Vital Signs - Psychomotor Speed Domain [ Time Frame: Baseline, Week 4, and Week 8 ]
    In-office neurocognitive test that is a non-invasive clinical procedure designed to efficiently and objectively assess a broad spectrum of brain function performance or domains under challenge. Finger tapping test and symbol digit coding will be aggregated to arrive at one reported value representing the psychomotor speed domain. Above average domain scores indicate a standard score (SS) greater than 109 or a Percentile Rank (PR) greater than 74, indicating a high functioning test subject. Average is a SS 90-109 or PR 25-74, indicating normal function. Low Average is a SS 80-89 or PR 9-24 indicating a slight deficit or impairment. Below Average is a SS 70-79 or PR 2-8, indicating a moderate level of deficit or impairment. Very Low is a SS less than 70 or a PR less than 2, indicating a deficit and impairment.
  • CNS Vital Signs - Executive Functioning Domain [ Time Frame: Baseline, Week 4, and Week 8 ]
    In-office neurocognitive test that is a non-invasive clinical procedure designed to efficiently and objectively assess a broad spectrum of brain function performance or domains under challenge. Shifting attention score will represent the executive functioning domain. Above average domain scores indicate a standard score (SS) greater than 109 or a Percentile Rank (PR) greater than 74, indicating a high functioning test subject. Average is a SS 90-109 or PR 25-74, indicating normal function. Low Average is a SS 80-89 or PR 9-24 indicating a slight deficit or impairment. Below Average is a SS 70-79 or PR 2-8, indicating a moderate level of deficit or impairment. Very Low is a SS less than 70 or a PR less than 2, indicating a deficit and impairment.
  • CNS Vital Signs - Reaction Time Domain [ Time Frame: Baseline, Week 4, and Week 8 ]
    In-office neurocognitive test that is a non-invasive clinical procedure designed to efficiently and objectively assess a broad spectrum of brain function performance or domains under challenge. Stroop test score will represent the reaction time domain. Above average domain scores indicate a standard score (SS) greater than 109 or a Percentile Rank (PR) greater than 74, indicating a high functioning test subject. Average is a SS 90-109 or PR 25-74, indicating normal function. Low Average is a SS 80-89 or PR 9-24 indicating a slight deficit or impairment. Below Average is a SS 70-79 or PR 2-8, indicating a moderate level of deficit or impairment. Very Low is a SS less than 70 or a PR less than 2, indicating a deficit and impairment.
  • CNS Vital Signs - Cognitive Flexibility Domain [ Time Frame: Baseline, Week 4, and Week 8 ]
    In-office neurocognitive test that is a non-invasive clinical procedure designed to efficiently and objectively assess a broad spectrum of brain function performance or domains under challenge. Shifting attention test and Stroop test scores will be aggregated to arrive at one reported value representing the cognitive flexibility domain. Above average domain scores indicate a standard score (SS) greater than 109 or a Percentile Rank (PR) greater than 74, indicating a high functioning test subject. Average is a SS 90-109 or PR 25-74, indicating normal function. Low Average is a SS 80-89 or PR 9-24 indicating a slight deficit or impairment. Below Average is a SS 70-79 or PR 2-8, indicating a moderate level of deficit or impairment. Very Low is a SS less than 70 or a PR less than 2, indicating a deficit and impairment.
  • Physical Activity Enjoyment Scale [ Time Frame: Week 1, Week 2, Week 3, and Week 4 ]
    scale of participant enjoyment in the moment. 7-point bipolar rating scale, eleven items are reverse scored. Higher total score reflect greater levels of enjoyment
  • Global Impression of Change [ Time Frame: Week 1, Week 2, Week 3, Week 4, and Week 8 ]
    9 point Likert scale. Higher positive score reflects great improvement
  • Heart Rate [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8 ]
    heart rate beats per minute
  • Blood Pressure [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8 ]
    systolic and diastolic, mm/Hg
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Augmented Reality and Treadmill Training After Traumatic Brain Injury
Official Title  ICMJE Augmented Reality and Treadmill Training After Traumatic Brain Injury
Brief Summary Up to 40 participants will be enrolled in this study in order to obtain complete data on 30 participants. The investigators will be assessing if Augmented reality in combination with treadmill training is safe and feasible to use in the clinical environment with participants who have chronic TBI and if there is a signal of effect that this intervention may be more beneficial than treadmill training alone or standard of care.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Behavioral: Augmented Reality
    Augmented Reality (AR) systems are computer-based applications that allow an individual to view a simulated environment and dynamically interact within this environment in real-time. Augmented reality activities will be chosen by the therapist based on the primary deficits assessed during baseline testing.
  • Behavioral: Treadmill training
    The goal of each session will be to increase balance and mobility challenge by increasing speed and minimizing BWS. Appropriate BWS will be chosen at the beginning of each training session. Participants will walk for 1 minute on the treadmill at 30%, 20% and 10% BWS. Maximum walking speed will be determined at each level of BWS and the participant will spend the remainder of the session ambulating with BWS at which they were able to achieve maximum walking speed. Additional BWS will be provided up to 30% of the participant's total body weight if the treating therapist identifies safety concerns or unfavorable gait kinematics. If a safe and kinematically appropriate gait pattern is unable to be achieved at up to 30% BWS, the previously determined walking speed will be reduced to achieve a safe and appropriate walking pattern. Participants will be encouraged not to use upper extremity support while ambulating with BWS.
  • Behavioral: Over ground training/standard of care

    Standard of care interventions to address balance and mobility deficits will be chosen from a list of commonly used interventions in outpatient therapy. The goal of each session will be to increase balance and mobility challenge in an over ground condition focusing treatment in the following areas:

    • Biomechanical Constraints
    • Stability Limits
    • Anticipatory Postural Adjustments
    • Reactive Postural Response
    • Sensory Orientation
    • Stability in Gait
Study Arms  ICMJE
  • Experimental: Augmented Reality+ Treadmill training
    Participants allocated to this group will receive treadmill training with body weight support (BWS) incorporating augmented feedback games chosen to address clinically perceived deficits using the C-Mill training system.
    Interventions:
    • Behavioral: Augmented Reality
    • Behavioral: Treadmill training
  • Active Comparator: Treadmill training
    Participants allocated to this group will receive treadmill training with body weight support (BWS) using the C-Mill training system.
    Intervention: Behavioral: Treadmill training
  • Active Comparator: Over ground training/standard of care
    Participants allocated to this group will receive over ground balance and mobility training that would be considered standard of care in outpatient rehabilitation.
    Intervention: Behavioral: Over ground training/standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sustained a TBI requiring inpatient rehabilitation
  • > 1 year post TBI
  • 18-65 years of age
  • Not currently participating in any other research study to address balance and gait impairment
  • Not currently participating in physical therapy
  • Ambulates with minimal assistance and/or assistive device
  • Self-report of ongoing balance deficits and mobility deficits
  • Score of 75 or below on CB&M
  • No history of other neurological disorders affecting balance
  • No seizures within the last year
  • No history of psychiatric disorder requiring hospitalization
  • Ability to follow directions and complete standardized instructions

Exclusion Criteria:

- No pregnant or lactating females (Potential female participants will be informed that risks to pregnant or lactating females are unknown; then they will be asked if they are pregnant or lactating, or if they could be pregnant. If there is any uncertainty, they will not be included in the study).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kaitlin Hays, DPT 3037898276 khays@craighospital.org
Contact: Angie Philippus, MS 3037898030 aphilippus@craighospital.org
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04553848
Other Study ID Numbers  ICMJE 1606744
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Candace Tefertiller, Craig Hospital
Study Sponsor  ICMJE Craig Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Craig Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP