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OpenTrials
Completed

NCT Number: NCT04553848

Augmented Reality and Treadmill Training After Traumatic Brain Injury

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Craig Hospital

Englewood, Colorado, 80113, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Augmented Reality

Behavioral

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.

Treadmill training

Behavioral

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.

Over ground training/standard of care

Behavioral

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

Primary outcomes

  1. Community Balance and Mobility Scale

    Time frame: Baseline to Week 8

    13 activities scored from 0-96, higher numbers reflect greater balance

Secondary outcomes

  1. 10 meter walk test

    Time frame: Baseline, Week 4, and Week 8

    total time to walk 10 meters

  2. 6 minute walk test

    Time frame: Baseline, Week 4, and Week 8

    distance walked in 6 minutes

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. Heart Rate

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8

    heart rate beats per minute

  14. Blood Pressure

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8

    systolic and diastolic, mm/Hg

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 18, 2020
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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