Augmented Reality and Treadmill Training After Traumatic Brain Injury

NCT ID: NCT04553848

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2021-10-01

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Augmented Reality

Intervention Type: BEHAVIORAL

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 training

Intervention Type: BEHAVIORAL

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.

Treadmill training

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

Group Type: ACTIVE_COMPARATOR

Treadmill training

Intervention Type: BEHAVIORAL

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 care

Participants allocated to this group will receive over ground balance and mobility training that would be considered standard of care in outpatient rehabilitation.

Group Type: ACTIVE_COMPARATOR

Over ground training/standard of care

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Candace Tefertiller

Executive Director of Research and Evaluation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Craig Hospital

Englewood, Colorado, United States

Countries

United States

Other Identifiers

1606744

Identifier Type: -

Identifier Source: org_study_id