High vs Low Intensity Virtual Reality Gait Training in Individuals With Chronic Stroke
NCT Number: NCT06522477
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Gait Disorders, Neurologic
Interventions: OTHER: Virtual reality gait training
Sponsor: Indiana University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-06-30
Locations: Rehabilitation Hospital of Indiana, Indianapolis, Indiana, 46254, United States

Summary:
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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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, 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