Augmented Reality and Treadmill Training After Traumatic Brain Injury

• ClinicalTrials.gov Identifier: NCT04553848
• Recruitment Status: Recruiting
• First Posted: September 18, 2020
• Last Update Posted: December 30, 2020
• Sponsor: Craig Hospital
• Information provided by (Responsible Party): Candace Tefertiller, Craig Hospital

Tracking Information

• First Submitted Date: September 3, 2020
• First Posted Date: September 18, 2020
• Last Update Posted Date: December 30, 2020
• Actual Study Start Date: October 19, 2020
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Augmented Reality and Treadmill Training After Traumatic Brain Injury
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Traumatic Brain Injury

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 11, 2020): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2021
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Kaitlin Hays, DPT; 3037898276; khays@craighospital.org

Contact: Angie Philippus, MS; 3037898030; aphilippus@craighospital.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04553848
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Candace Tefertiller, Craig Hospital
• Study Sponsor: Craig Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Craig Hospital
• Verification Date: December 2020