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

NCT06522477 | Withdrawn DMC

• 1 other identifier: 23656
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Gait Disorders, Neurologic

Keywords

stroke; gait; rehabilitation; high-intensity; virtual reality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Mini Balance Evaluation Systems Test

  After 5 weeks of training

• Steps per Day

  After 5 weeks of training

• 30 second Sit to Stand Test

  After 5 weeks of training

• Activity-Specific Balance Confidence (ABC) Scale

  After 5 weeks of training

• Medical Outcomes Survey Short-Form 36 (SF-36)

  After 5 weeks of training

Study Arms (2)

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.

Other: 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.

Other: 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.

High-intensity followed by low-intensity virtual reality gait training; Low-intensity followed by high-intensity virtual reality gait training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Henderson, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded clinical assessors will perform assessments of clinical outcomes.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 26, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after completion of study for 3 years

Locations

US (1)