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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Augmented Reality; Behavioral: Treadmill training; Behavioral: Over ground training/standard of care

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Craig Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Community Balance and Mobility Scale	13 activities scored from 0-96, higher numbers reflect greater balance	Baseline to Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 meter walk test	total time to walk 10 meters	Baseline, Week 4, and Week 8
6 minute walk test	distance walked in 6 minutes	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	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	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	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	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.	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.	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.	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.	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	Week 1, Week 2, Week 3, and Week 4
Global Impression of Change	9 point Likert scale. Higher positive score reflects great improvement	Week 1, Week 2, Week 3, Week 4, and Week 8
Heart Rate	heart rate beats per minute	Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8
Blood Pressure	systolic and diastolic, mm/Hg	Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8

Collaborators and Investigators

• Sponsor: Craig Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 1606744

Drug and device information, study documents

• 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