Augmented Reality and Treadmill Training After Traumatic Brain Injury

Craig Hospital

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Behavioral: Treadmill training; Behavioral: Over ground training/standard of care; Behavioral: Augmented Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT04553848

1606744

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 3 patient groups

Augmented Reality+ Treadmill training

Experimental group

Description:

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.

Treatment:

Behavioral: Treadmill training

Behavioral: Augmented Reality

Treadmill training

Active Comparator group

Description:

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

Treatment:

Behavioral: Treadmill training

Over ground training/standard of care

Active Comparator group

Description:

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

Treatment:

Behavioral: Over ground training/standard of care