---
title: High Vs Low Intensity Virtual Reality Gait Training in Individuals with Chronic Stroke
nct_id: NCT06522477
overall_status: WITHDRAWN
phase: NA
sponsor: Indiana University
study_type: INTERVENTIONAL
primary_condition: Stroke
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06522477.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06522477"
ct_last_update_post_date: 2024-10-18
last_seen_at: "2026-05-12T07:14:15.088Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT06522477](https://clinicaltrials.gov/study/NCT06522477)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** Did not receive funding
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Indiana University
- **Conditions:** Stroke, Gait Disorders, Neurologic
- **Start Date:** 2024-11-01
- **Completion Date:** 2026-06-30
- **CT.gov Last Update:** 2024-10-18

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **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
```

## Arms

- **High-intensity followed by low-intensity virtual reality gait training** (EXPERIMENTAL) — 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.
- **Low-intensity followed by high-intensity virtual reality gait training** (EXPERIMENTAL) — 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.

## Interventions

- **Virtual reality gait training** (OTHER) — 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.

## Primary Outcomes

- **Gait speed** _(time frame: 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** _(time frame: After 5 weeks of training)_ — Individuals will be asked to "cover as much ground as possible" over a six minute period.
- **Peak treadmill speed** _(time frame: 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 Outcomes

- **Mini Balance Evaluation Systems Test** _(time frame: After 5 weeks of training)_
- **Steps per Day** _(time frame: After 5 weeks of training)_
- **30 second Sit to Stand Test** _(time frame: After 5 weeks of training)_
- **Activity-Specific Balance Confidence (ABC) Scale** _(time frame: After 5 weeks of training)_
- **Medical Outcomes Survey Short-Form 36 (SF-36)** _(time frame: After 5 weeks of training)_
- **Oxygen Consumption** _(time frame: After 5 weeks of training)_

## Locations (1)

- Rehabilitation Hospital of Indiana, Indianapolis, Indiana, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.rehabilitation hospital of indiana|indianapolis|indiana|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06522477.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06522477*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*