Effect of Lower Limb Exproprioception Training in Virtual Environment on Locomotion Performance in Stroke Patients

The purpose of this study is to determine if a virtual reality training of foot placement with or without visual cues about the location of the foot in the environment would improve locomotion-related function in persons in the chronic stage of stroke. Participants were randomly assigned to receive twice per week, for a total of 2 weeks' training with visual cues (control group) or without (experimental group). It was hypothesized that the experimental group would be able to place the foot closer to the target when stepping and have more symmetrical gait. So far, 22 stroke patients completed the experiment. Preliminary results support the hypothesis. This project is still ongoing.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Exercise Training; Virtual Reality; Spatial Perception; Exproprioception
• Intervention / Treatment: Other: Virtual reality foot placement training

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sang-I Lin, PhD; Phone Number: 5020 +88662353535; Email: lin31@mail.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • Recruiting
    • National Cheng Kung University
    • Contact: Sang-I Lin, PhD; Phone Number: 5020 +886-6-235-3535; Email: lin31@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• first time unilateral stroke and onset over 6 months
• able to independent walking with or without aids over 10 meters
• Mini-Mental State Examination (MMSE) score above 24
• orientation intake, able to identify right and left
• normal or corrected-to-normal vision, able to see the 2 cm diameter circle on the floor while standing

Exclusion Criteria:

• gait nearly normal
• had other neurological and musculoskeletal disease which can affect walking ability
• hemineglect
• use virtual reality device will severely discomfort, such as headaches, blurred vision, vertigo or vomiting

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-visual exproprioception training; The training requires the participant to place the foot at a target without visual cues of the foot in virtual environment.	Other: Virtual reality foot placement training; The training is conducted in sitting and standing, and involves both the affected and unaffected foot placement. In the total immersive virtual environment, a target will be presented and the participants are required to move one foot to the target. The location of the moving foot is not seen by the participant in this training.
Active Comparator: Visual exproprioception group; The training requires the participant to place the foot at a target with visual cues of the foot in virtual environment.	Other: Virtual reality foot placement training; The training is conducted in sitting and standing, and involves both the affected and unaffected foot placement. In the total immersive virtual environment, a target will be presented and the participants are required to move one foot to the target. The location of the moving foot is not seen by the participant in this training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
foot placement accuracy (cm)	The distance between the foot and the target in various stepping tasks	2 weeks
gait symmetry	ratio of the two leg step lengths	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exproprioception (cm)	the error in placing the unaffected foot at a location previously defined by the affected foot	2 weeks

Collaborators and Investigators

• Sponsor: National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2019
• Primary Completion (Anticipated): December 10, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: A-ER-108-183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No