Gait Disorders, Neurologic, Stroke
Conditions
Keywords
stroke, gait, rehabilitation, high-intensity, virtual reality
Brief 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.
Detailed description
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.
Interventions
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.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded clinical assessors will perform assessments of clinical outcomes.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral deficits following stroke \> 6 months prior; however individuals \> 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until \> 6 months * Age 18-85 years * Weight \< 350 pounds * Able to follow a 3-step command * Able to ambulate with self-selected gait speeds between 0.01-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed * Lower extremity Fugl-Meyer \< 34 * Medical clearance to participate
Exclusion criteria
* Evidence of cerebellar ataxia * Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities * Currently participating in other physical therapy * \> 50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months. Note that participants may be consented prior to 3 months post-injection; however, eligibility will be determined post 3 months. * Unable to read \> 50% of the letters on the 20/70 line of the Snellen Chart with customary eye wear at a distance of 20 feet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait speed | After 5 weeks of training | 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. |
| 6 minute walk test | After 5 weeks of training | Individuals will be asked to cover as much ground as possible over a six minute period. |
| Peak treadmill speed | After 5 weeks of training | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity-Specific Balance Confidence (ABC) Scale | After 5 weeks of training | 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. |
| Mini Balance Evaluation Systems Test | After 5 weeks of training | 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. |
| Oxygen Consumption | After 5 weeks of training | 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. |
| Medical Outcomes Survey Short-Form 36 (SF-36) | After 5 weeks of training | 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). |
| Steps per Day | After 5 weeks of training | 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. |
| 30 second Sit to Stand Test | After 5 weeks of training | 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. |
Countries
United States
Outcome results
None listed