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The purpose of this pilot study is to investigate the feasibility of 1) providing virtual reality walking training using a custom developed setup able to be replicated in routine clinical practice and 2) combining the virtual reality training with high-intensity gait training.
This study will utilize a randomized-crossover design. Following confirmation of eligibility and completion of Baseline 1 testing, individuals will be randomized to receive up to 15 visits over approximately 5 weeks of either high or low intensity virtual reality gait training. Following which, individuals will undergo Post 1 testing to capture potential change in outcomes following the intervention. Participants will then take at least a 4-week break before returning to complete Baseline 2 testing and up 15 visits over 5 weeks of the alternative intervention before finally completing Post 2 testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity followed by low-intensity virtual reality gait training | Experimental | Individuals randomized to this group will first perform high-intensity virtual reality gait training and following a 4-week washout period will complete low-intensity virtual reality gait training. |
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| Low-intensity followed by high-intensity virtual reality gait training | Experimental | Individuals randomized to this group will first perform low-intensity virtual reality gait training and following a 4-week washout period will complete high-intensity virtual reality gait training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality gait training | Other | Individuals will walk on a treadmill with overhead harness system in place while viewing 1st-person perspective walking videos on a television placed immediately in front of the treadmill. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait speed | This is an assessment of overground walking speed measured across a distance of ~20 feet and will be conducted at both self-selected (instructions: "walk at your usual, comfortable pace") and fastest (instructions: "walk as fast as you safely can") walking speeds. | After 5 weeks of training |
| 6 minute walk test | Individuals will be asked to "cover as much ground as possible" over a six minute period. | After 5 weeks of training |
| Peak treadmill speed | Individuals will participate in a walking-based graded exercise test. While harnessed for safety on a treadmill, the treadmill will be initially set to 0.1 m/s and increased by 0.1 m/s each minute until the test is terminated due to one of the following: 1) the participant requests to stop, 2) the participant is unable to keep up with the speed of the treadmill and/or loses their balance, 3) any of the absolute exercise test termination criteria provided by American College of Sports Medicine are present. The highest speed that the individual can walk for a minute at is the peak treadmill speed. | After 5 weeks of training |
| Measure | Description | Time Frame |
|---|---|---|
| Mini Balance Evaluation Systems Test | 14 item assessment of static and dynamic balance. Example tasks include sit to stand, stand on one leg, standing stepping reactions, and walking with head turns. | After 5 weeks of training |
| Steps per Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Henderson, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Hospital of Indiana | Indianapolis | Indiana | 46254 | United States |
De-identified data available upon reasonable request
after completion of study for 3 years
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Individuals will be randomly assigned to receive up to 15 visits/5 weeks of high- or low-intensity virtual reality gait training. Following a 4 week washout, they will complete the alternative intervention.
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Blinded clinical assessors will perform assessments of clinical outcomes.
Participants will wear a research-grade pedometer (StepWatch; Modus Health) during waking hours for ~1-2 weeks before beginning each training protocol and after completing training protocol to quantify home and community mobility.
| After 5 weeks of training |
| 30 second Sit to Stand Test | Participants will be asked to rise from a chair without using their arms and then return to sitting as many times as possible in 30 seconds. | After 5 weeks of training |
| Activity-Specific Balance Confidence (ABC) Scale | This questionnaire asks individuals to rate their balance-confidence from 0 (no confidence) to 100 (completely confident) during a variety of 16 commonly performed tasks such as walking around a house or getting into a car. | After 5 weeks of training |
| Medical Outcomes Survey Short-Form 36 (SF-36) | This 36-question survey asks individuals about how their current health may limit their ability to perform typical physical and social activities. Scores range from 0 (negative health) to 100 (positive health). | After 5 weeks of training |
| Oxygen Consumption | Oxygen consumption will be measured via a portable metabolic cart (K5; COSMED) during the previously described graded exercise test. Participant will wear a snug fitting mask that covers their mouth and nose, but does not affect the amount or quality of air that they breathe. The mask will be connected to a small backpack that collects information on the rate of breathing and oxygen consumed. | After 5 weeks of training |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |