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

Sponsor

National Cheng Kung University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04436237

Collaborator

(none)

Enrollment

Location

Arms

28.2

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Spatial Perception Stroke Virtual Reality Exercise Training Exproprioception	Other: Virtual reality foot placement training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 26, 2019

Anticipated Primary Completion Date :

Dec 10, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

foot placement accuracy (cm) [2 weeks]
The distance between the foot and the target in various stepping tasks
gait symmetry [2 weeks]
ratio of the two leg step lengths

Secondary Outcome Measures

exproprioception (cm) [2 weeks]
the error in placing the unaffected foot at a location previously defined by the affected foot

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cheng Kung University	Tainan		Taiwan	701

Sponsors and Collaborators

National Cheng Kung University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sang-I Lin, Professor, National Cheng Kung University

ClinicalTrials.gov Identifier:

NCT04436237

Other Study ID Numbers:

A-ER-108-183

First Posted:

Jun 17, 2020

Last Update Posted:

Sep 5, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Sep 5, 2021