Augmented Reality and Treadmill Training After Traumatic Brain Injury

NCT04553848 | Completed

• 1 other identifier: 1606744
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Community Balance and Mobility Scale

  13 activities scored from 0-96, higher numbers reflect greater balance

  Baseline to Week 8

Secondary Outcomes (14)

• 10 meter walk test

  Baseline, Week 4, and Week 8

• 6 minute walk test

  Baseline, Week 4, and Week 8

• Timed Up and Go

  Baseline, Week 4, and Week 8

• Timed Up and Go Cognitive Test

  Baseline, Week 4, and Week8

• Timed Up and Go Manual

  Baseline, Week 4, and Week 8

Study Arms (3)

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.

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.

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.

Behavioral: Over ground training/standard of care

Interventions

Augmented Reality 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.

Augmented Reality+ Treadmill training

Treadmill training 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.

Augmented Reality+ Treadmill training; Treadmill training

Over ground training/standard of care 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

Over ground training/standard of care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sustained a TBI requiring inpatient rehabilitation
• \> 1 year post TBI
• 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

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of Research and Evaluation

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 18, 2020
• Study Start: October 19, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

US (1)