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

Study Overview
=================
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.

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

Conditions
-----------------
Spatial Perception, Stroke, Virtual Reality, Exercise Training, Exproprioception

Intervention / Treatment
-----------------
* Other: Virtual reality foot placement training


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-visual exproprioception training<br>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<br>* 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.<br>|
| Active Comparator: Visual exproprioception group<br>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<br>* 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.<br>|

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 |