High Vs Low Intensity Virtual Reality Gait Training in Individuals with Chronic Stroke

Feasibility of High and Low Intensity Virtual Reality Gait Training in Individuals with Chronic Stroke: a Pilot Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Stroke; Gait Disorders, Neurologic
• Intervention / Treatment: Other: Virtual reality 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46254
      • Rehabilitation Hospital of Indiana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-intensity followed by low-intensity virtual reality gait training; 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 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.
Experimental: Low-intensity followed by high-intensity 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Christopher Henderson, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: stroke; gait; rehabilitation; virtual reality; high-intensity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Stroke; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 23656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data available upon reasonable request
• IPD Sharing Time Frame: after completion of study for 3 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No