An interventional study of Virtual reality gait training in Stroke and Gait Disorders, Neurologic, sponsored by Indiana University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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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Exclusion Criteria:
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.
Other: Virtual reality gait training
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.
Other: Virtual reality gait training
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: After 5 weeks of training
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.
Time frame: After 5 weeks of training
Steps per Day
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: After 5 weeks of training
Plan to share: Yes — De-identified data available upon reasonable request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: after completion of study for 3 years
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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