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

NCT04436237 | Unknown

• 1 other identifier: A-ER-108-183
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• exproprioception (cm)

  2 weeks

Study Arms (2)

Non-visual exproprioception training

EXPERIMENTAL

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

Visual exproprioception group

ACTIVE COMPARATOR

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

Interventions

Virtual reality foot placement training OTHER

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.

Non-visual exproprioception training; Visual exproprioception group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

RECRUITING

MeSH Terms

Conditions

Orientation, Spatial; Stroke

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sang-I Lin, PhD

CONTACT

+88662353535; lin31@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 17, 2020
• Study Start: August 26, 2019
• Primary Completion: December 10, 2021
• Study Completion: December 31, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

TW (1)