The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help stroke survivors improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for stroke survivors.
After obtaining consent and screening, eligible participants are randomized to the treatment or control groups. First, all participants are issued a wearable tracker to gauge baseline activity for at least 5 days. During the intervention phase, participants undergo 12 treatment sessions, 2x a week for 6 weeks. Assessments are conducted at pre-intervention, post-intervention, and 1-month followup.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Fully-immersive, real-world environments, overground gait therapy
Semi-immersive, game-like environments, treadmill gait therapy
Indiana University Health, Neurorehabilitation & Robotics
Indianapolis, Indiana, United States
RECRUITINGStep Count
FitBit tracks the number of steps (count) taken by participant.
Time frame: Continuous tracking from Screening to Week 10
Travel Distance
FitBit tracks the total distance (miles) travelled by participant.
Time frame: Continuous tracking from Screening to Week 10
Activity Zone Minutes
Fitbit calculates maximum heart rate (HR) from user age (Max HR = 220 - age) and defines Activity Zone thresholds based on percentages of max HR (Fat Burn 50-69%, Cardio/Peak \>70%). Activity Zone Minutes (AZMs) are an intensity-weighted measure of activity. AZM (count) is based on sustained heart rate over time: 1 AZM per minute in the Fat Burn Zone (50-69% max HR) and 2 AZMs per minute in the Cardio/Peak Zones (\>=70% max HR).
Time frame: Continuous tracking from Screening to Week 10
10-Meter Walk Test
10MWT: Subjects will walk a distance of 10 meters at their normal pace while being timed, allowing assessment of gait speed and mobility.
Time frame: Baseline, Week 7, Week 10
6-Minute Walk Test
6MWT: Subjects will walk for 6 minutes along a 30m track. Subjects may stop and rest as often as needed. Subject walking speed will be collected during the test to evaluate the rate of functional fatigue.
Time frame: Baseline, Week 7, Week 10
Mini-Balance Evaluation Systems Test
Mini-BESTest: Subjects will complete 14 different tasks ranging from static standing to dynamic walking. All subjects will be guarded closely for safety to prevent falling.
Time frame: Baseline, Week 7, Week 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Timed Up and Go Test
TUG: Subjects will rise from a seated position, walk three meters, turn around, walk back to the chair, and sit down. This test is used to assess mobility, balance, walking ability, and fall risk.
Time frame: Baseline, Week 7, Week 10
Step-Over Test
SOT: Patients will walk over a flat firm surface for 14 meters. The pathway will include a box that is one foot wide. Each participant will complete 10 passes, stepping over the obstacle (box) each time.
Time frame: Baseline, Week 7, Week 10
Step Length
With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Step length (centimeters) measures the distance between the heel contact point of one foot to the heel contact point of the other foot.
Time frame: Baseline, Week 7, Week 10
Stride Length
With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Stride length (centimeters) measures the distance between successive heel contact points of the same foot.
Time frame: Baseline, Week 7, Week 10
Stance Percentage
With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. During the gait cycle, each foot alternates between being in contact with the ground (stance phase) and not in contact with the ground (swing phase). Stance percentage (percent) is the proportion of the gait cycle during which a foot remains in the stance phase.
Time frame: Baseline, Week 7, Week 10
Gait Speed
With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Gait speed (meters per second) is calculated by dividing the distance walked (meters) by the time taken (seconds).
Time frame: Baseline, Week 7, Week 10