Augmented Reality and Treadmill Training After Traumatic Brain Injury

Sponsor

Craig Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04553848

Collaborator

(none)

Enrollment

Location

Arms

11.4

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Behavioral: Augmented Reality Behavioral: Treadmill training Behavioral: Over ground training/standard of care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Augmented Reality and Treadmill Training After Traumatic Brain Injury

Actual Study Start Date :

Oct 19, 2020

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
Active Comparator: Treadmill training Participants allocated to this group will receive treadmill training with body weight support (BWS) using the C-Mill training system.	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.
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.	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

Arm

Intervention/Treatment

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.

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.

Active Comparator: Treadmill training

Participants allocated to this group will receive treadmill training with body weight support (BWS) using the C-Mill training system.

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.

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

Outcome Measures

Primary Outcome Measures

Community Balance and Mobility Scale [Baseline to Week 8]
13 activities scored from 0-96, higher numbers reflect greater balance

Secondary Outcome Measures

10 meter walk test [Baseline, Week 4, and Week 8]
total time to walk 10 meters
6 minute walk test [Baseline, Week 4, and Week 8]
distance walked in 6 minutes
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
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
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
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
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.
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.
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.
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.
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
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
Heart Rate [Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8]
heart rate beats per minute
Blood Pressure [Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8]
systolic and diastolic, mm/Hg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Craig Hospital	Englewood	Colorado	United States	80113

Sponsors and Collaborators

Craig Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Candace Tefertiller, Executive Director of Research and Evaluation, Craig Hospital

ClinicalTrials.gov Identifier:

NCT04553848

Other Study ID Numbers:

1606744

First Posted:

Sep 18, 2020

Last Update Posted:

Jan 28, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Brain Injuries

Brain Injuries, Traumatic

Wounds and Injuries

Study Results

No Results Posted as of Jan 28, 2022