Traumatic Brain InjuryNCT04553848
Augmented Reality and Treadmill Training After Traumatic Brain Injury
A study testing Augmented Reality and Treadmill training in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Augmented Reality and Treadmill training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Augmented Reality, Treadmill training, Over ground training/standard of care
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented RealityBehavioural
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 trainingBehavioural
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 careBehavioural
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 group | Role | What they receive |
|---|---|---|
| Augmented Reality+ Treadmill training | Experimental | 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. Receives: Behavioral: Augmented Reality; Behavioral: Treadmill training |
| Treadmill training | Active comparator | Participants allocated to this group will receive treadmill training with body weight support (BWS) using the C-Mill training system. Receives: Behavioral: Treadmill training |
| Over ground training/standard of care | Active comparator | Participants allocated to this group will receive over ground balance and mobility training that would be considered standard of care in outpatient rehabilitation. Receives: Behavioral: Over ground training/standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community Balance and Mobility Scale
13 activities scored from 0-96, higher numbers reflect greater balance
Measured: Baseline to Week 8
Secondary outcomes (14)
10 meter walk test
total time to walk 10 meters
Measured: Baseline, Week 4, and Week 8
6 minute walk test
distance walked in 6 minutes
Measured: Baseline, Week 4, and Week 8
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
Measured: Baseline, Week 4, and Week 8
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
Measured: Baseline, Week 4, and Week8
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
Measured: Baseline, Week 4, and Week 8
Activities-Specific Confidence Scale
16 item measure, scored from 0 to 100. Higher scores reflect great confidence of task
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
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
Measured: Week 1, Week 2, Week 3, and Week 4
Global Impression of Change
9 point Likert scale. Higher positive score reflects great improvement
Measured: Week 1, Week 2, Week 3, Week 4, and Week 8
Heart Rate
heart rate beats per minute
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8
Blood Pressure
systolic and diastolic, mm/Hg
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start19 Oct 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candace Tefertiller, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553848
- Sponsor's protocol ID
- 1606744
- Status last verified
- Jan 2022
- First submitted
- 3 Sep 2020
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality and Treadmill Training After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04553848
- Acronym / sponsor ID
- 1606744
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality+ Treadmill training | Experimental | Behavioral: Augmented Reality, Behavioral: Treadmill trainingParticipants 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 | Active comparator | Behavioral: Treadmill trainingParticipants 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 | Active comparator | Behavioral: Over ground training/standard of careParticipants allocated to this group will receive over ground balance and mobility training that would be considered standard of care in outpatient rehabilitation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented RealityAugmented 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. | Behavioural | Augmented Reality+ Treadmill training |
| Treadmill trainingThe 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. | Behavioural | Augmented Reality+ Treadmill training, Treadmill training |
| Over ground training/standard of careStandard 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 | Behavioural | Over ground training/standard of care |
Primary outcome
Community Balance and Mobility Scale
Time frame: Baseline to Week 8
13 activities scored from 0-96, higher numbers reflect greater balance
14 secondary outcomes
10 meter walk test
Time frame: Baseline, Week 4, and Week 8
6 minute walk test
Time frame: Baseline, Week 4, and Week 8
Timed Up and Go
Time frame: Baseline, Week 4, and Week 8
Timed Up and Go Cognitive Test
Time frame: Baseline, Week 4, and Week8
Timed Up and Go Manual
Time frame: Baseline, Week 4, and Week 8
Activities-Specific Confidence Scale
Time frame: Baseline, Week 4, and Week 8
CNS Vital Signs - Psychomotor Speed Domain
Time frame: Baseline, Week 4, and Week 8
CNS Vital Signs - Executive Functioning Domain
Time frame: Baseline, Week 4, and Week 8
CNS Vital Signs - Reaction Time Domain
Time frame: Baseline, Week 4, and Week 8
CNS Vital Signs - Cognitive Flexibility Domain
Time frame: Baseline, Week 4, and Week 8
Physical Activity Enjoyment Scale
Time frame: Week 1, Week 2, Week 3, and Week 4
Global Impression of Change
Time frame: Week 1, Week 2, Week 3, Week 4, and Week 8
Heart Rate
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8
Blood Pressure
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality and Treadmill training in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Community Balance and Mobility Scale (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.