Back to resultsAugmented Reality and Treadmill Training After Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Augmented Reality
Treadmill training
Over ground training/standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
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).
Sites / Locations
- Craig Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Augmented Reality+ Treadmill training
Treadmill training
Over ground training/standard of care
Arm Description
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.
Participants allocated to this group will receive treadmill training with body weight support (BWS) using the C-Mill training system.
Participants allocated to this group will receive over ground balance and mobility training that would be considered standard of care in outpatient rehabilitation.
Outcomes
Primary Outcome Measures
Community Balance and Mobility Scale
13 activities scored from 0-96, higher numbers reflect greater balance
Secondary Outcome Measures
10 meter walk test
total time to walk 10 meters
6 minute walk test
distance walked in 6 minutes
Timed Up and Go
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
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
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
16 item measure, scored from 0 to 100. Higher scores reflect great confidence of task
CNS Vital Signs - Psychomotor Speed Domain
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
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
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
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
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
9 point Likert scale. Higher positive score reflects great improvement
Heart Rate
heart rate beats per minute
Blood Pressure
systolic and diastolic, mm/Hg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04553848
Brief Title
Augmented Reality and Treadmill Training After Traumatic Brain Injury
Official Title
Augmented Reality and Treadmill Training After Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Craig Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Augmented Reality+ Treadmill training
Arm Type
Experimental
Arm Description
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.
Arm Title
Treadmill training
Arm Type
Active Comparator
Arm Description
Participants allocated to this group will receive treadmill training with body weight support (BWS) using the C-Mill training system.
Arm Title
Over ground training/standard of care
Arm Type
Active Comparator
Arm Description
Participants allocated to this group will receive over ground balance and mobility training that would be considered standard of care in outpatient rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
Augmented Reality
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treadmill training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Over ground training/standard of care
Intervention Description
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 Outcome Measure Information:
Title
Community Balance and Mobility Scale
Description
13 activities scored from 0-96, higher numbers reflect greater balance
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
10 meter walk test
Description
total time to walk 10 meters
Time Frame
Baseline, Week 4, and Week 8
Title
6 minute walk test
Description
distance walked in 6 minutes
Time Frame
Baseline, Week 4, and Week 8
Title
Timed Up and Go
Description
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
Time Frame
Baseline, Week 4, and Week 8
Title
Timed Up and Go Cognitive Test
Description
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
Time Frame
Baseline, Week 4, and Week8
Title
Timed Up and Go Manual
Description
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
Time Frame
Baseline, Week 4, and Week 8
Title
Activities-Specific Confidence Scale
Description
16 item measure, scored from 0 to 100. Higher scores reflect great confidence of task
Time Frame
Baseline, Week 4, and Week 8
Title
CNS Vital Signs - Psychomotor Speed Domain
Description
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.
Time Frame
Baseline, Week 4, and Week 8
Title
CNS Vital Signs - Executive Functioning Domain
Description
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.
Time Frame
Baseline, Week 4, and Week 8
Title
CNS Vital Signs - Reaction Time Domain
Description
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.
Time Frame
Baseline, Week 4, and Week 8
Title
CNS Vital Signs - Cognitive Flexibility Domain
Description
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.
Time Frame
Baseline, Week 4, and Week 8
Title
Physical Activity Enjoyment Scale
Description
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
Time Frame
Week 1, Week 2, Week 3, and Week 4
Title
Global Impression of Change
Description
9 point Likert scale. Higher positive score reflects great improvement
Time Frame
Week 1, Week 2, Week 3, Week 4, and Week 8
Title
Heart Rate
Description
heart rate beats per minute
Time Frame
Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8
Title
Blood Pressure
Description
systolic and diastolic, mm/Hg
Time Frame
Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
12. IPD Sharing Statement
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Augmented Reality and Treadmill Training After Traumatic Brain Injury
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