Clinical trial NCT04553848: Augmented Reality and Treadmill Training After Traumatic Brain Injury
Official title: Augmented Reality and Treadmill Training After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Craig Hospital
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Community Balance and Mobility Scale
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: 10 meter walk test
timeFrame: Baseline, Week 4, and Week 8
measure: 6 minute walk test
timeFrame: Baseline, Week 4, and Week 8
measure: Timed Up and Go
timeFrame: Baseline, Week 4, and Week 8
measure: Timed Up and Go Cognitive Test
timeFrame: Baseline, Week 4, and Week8
measure: Timed Up and Go Manual
timeFrame: Baseline, Week 4, and Week 8
measure: Activities-Specific Confidence Scale
timeFrame: Baseline, Week 4, and Week 8
measure: CNS Vital Signs - Psychomotor Speed Domain
timeFrame: Baseline, Week 4, and Week 8
measure: CNS Vital Signs - Executive Functioning Domain
timeFrame: Baseline, Week 4, and Week 8
measure: CNS Vital Signs - Reaction Time Domain
timeFrame: Baseline, Week 4, and Week 8
measure: CNS Vital Signs - Cognitive Flexibility Domain
timeFrame: Baseline, Week 4, and Week 8
measure: Physical Activity Enjoyment Scale
timeFrame: Week 1, Week 2, Week 3, and Week 4
measure: Global Impression of Change
timeFrame: Week 1, Week 2, Week 3, Week 4, and Week 8
measure: Heart Rate
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8
measure: Blood Pressure
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, and Week 8
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
References: