Augmented Reality and Treadmill Training After Traumatic Brain Injury
- Conditions
- Traumatic Brain Injury
- Interventions
- Behavioral: Augmented RealityBehavioral: Over ground training/standard of careBehavioral: Treadmill training
- Registration Number
- NCT04553848
- Lead Sponsor
- Craig Hospital
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Augmented Reality+ Treadmill training Augmented Reality 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. Augmented Reality+ Treadmill training 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. Treadmill training Treadmill training Participants allocated to this group will receive treadmill training with body weight support (BWS) using the C-Mill training system. Over ground training/standard of care 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.
- Primary Outcome Measures
Name Time Method Community Balance and Mobility Scale Baseline to Week 8 13 activities scored from 0-96, higher numbers reflect greater balance
- Secondary Outcome Measures
Name Time Method 10 meter walk test Baseline, Week 4, and Week 8 total time to walk 10 meters
Activities-Specific Confidence Scale Baseline, Week 4, and Week 8 16 item measure, scored from 0 to 100. Higher scores reflect great confidence of task
Timed Up and Go Cognitive Test 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
6 minute walk test Baseline, Week 4, and Week 8 distance walked in 6 minutes
Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8 systolic and diastolic, mm/Hg
Timed Up and Go Manual 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
Global Impression of Change Week 1, Week 2, Week 3, Week 4, and Week 8 9 point Likert scale. Higher positive score reflects great improvement
Timed Up and Go 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
CNS Vital Signs - Reaction Time Domain 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.
Physical Activity Enjoyment Scale 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
CNS Vital Signs - Cognitive Flexibility Domain 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.
CNS Vital Signs - Executive Functioning Domain 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.
Heart Rate Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8 heart rate beats per minute
CNS Vital Signs - Psychomotor Speed Domain 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.
Trial Locations
- Locations (1)
Craig Hospital
🇺🇸Englewood, Colorado, United States