Clinical trial NCT06522477: High Vs Low Intensity Virtual Reality Gait Training in Individuals with Chronic Stroke
Official title: Feasibility of High and Low Intensity Virtual Reality Gait Training in Individuals with Chronic Stroke: a Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Gait Disorders, Neurologic
Keywords: stroke
gait
rehabilitation
high-intensity
virtual reality
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait speed
timeFrame: After 5 weeks of training
measure: 6 minute walk test
timeFrame: After 5 weeks of training
measure: Peak treadmill speed
timeFrame: After 5 weeks of training
Secondary outcomes:
measure: Mini Balance Evaluation Systems Test
timeFrame: After 5 weeks of training
measure: Steps per Day
timeFrame: After 5 weeks of training
measure: 30 second Sit to Stand Test
timeFrame: After 5 weeks of training
measure: Activity-Specific Balance Confidence (ABC) Scale
timeFrame: After 5 weeks of training
measure: Medical Outcomes Survey Short-Form 36 (SF-36)
timeFrame: After 5 weeks of training
measure: Oxygen Consumption
timeFrame: After 5 weeks of training
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Rehabilitation Hospital of Indiana
state: Indiana
Study officials:
affiliation: Indiana University
name: Christopher Henderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: