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

Primary Purpose

Spatial Perception, Stroke, Virtual Reality

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Virtual reality foot placement training

About this trial

This is an interventional treatment trial for Spatial Perception

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

National Cheng Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-visual exproprioception training

Visual exproprioception group

Arm Description

The training requires the participant to place the foot at a target without visual cues of the foot in virtual environment.

The training requires the participant to place the foot at a target with visual cues of the foot in virtual environment.

Outcomes

Primary Outcome Measures

foot placement accuracy (cm)

The distance between the foot and the target in various stepping tasks

gait symmetry

ratio of the two leg step lengths

Secondary Outcome Measures

exproprioception (cm)

the error in placing the unaffected foot at a location previously defined by the affected foot

Full Information

NCT ID

NCT04436237

First Posted

June 12, 2020

Last Updated

September 3, 2021

Sponsor

National Cheng Kung University

1. Study Identification

Unique Protocol Identification Number

NCT04436237

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 26, 2019 (Actual)

Primary Completion Date

December 10, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Non-visual exproprioception training

Arm Type

Experimental

Arm Description

The training requires the participant to place the foot at a target without visual cues of the foot in virtual environment.

Arm Title

Visual exproprioception group

Arm Type

Active Comparator

Arm Description

The training requires the participant to place the foot at a target with visual cues of the foot in virtual environment.

Intervention Type

Other

Intervention Name(s)

Virtual reality foot placement training

Intervention Description

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.

Primary Outcome Measure Information:

Title

foot placement accuracy (cm)

Description

The distance between the foot and the target in various stepping tasks

Time Frame

2 weeks

Title

gait symmetry

Description

ratio of the two leg step lengths

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

exproprioception (cm)

Description

the error in placing the unaffected foot at a location previously defined by the affected foot

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sang-I Lin, PhD

Phone

+88662353535

Ext

5020

lin31@mail.ncku.edu.tw

Facility Information:

Facility Name

National Cheng Kung University

City

Tainan

ZIP/Postal Code

701

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sang-I Lin, PhD

Phone

+886-6-235-3535

Ext

5020

lin31@mail.ncku.edu.tw

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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