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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436237
• Other study ID #: A-ER-108-183
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: National Cheng Kung University
• Contact: Sang-I Lin, PhD
• Phone: +88662353535
• Email: lin31[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	foot placement accuracy (cm)	The distance between the foot and the target in various stepping tasks	2 weeks
Primary	gait symmetry	ratio of the two leg step lengths	2 weeks
Secondary	exproprioception (cm)	the error in placing the unaffected foot at a location previously defined by the affected foot	2 weeks