The Cycling Exercise With Virtual Reality Visual Stimulation for Rehabilitation in CVA Patients
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
virtual reality-cycling training system
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke,, rehabilitation,, leg cycling,, feedback,, virtual reality
Eligibility Criteria
Inclusion Criteria:
- single stroke with unilateral hemiplegia (Brunnstrom stage III);
- hypertonia in the affected leg, modified Ashworth scale (MAS) grade ≦ 2;
- no significant perceptual, cognitive, or sensory deficits;
- no history of osteoarthritis, severe cardiopulmonary disease, or vascular disease in lower limbs
- lack of a fixed contracture in the affected lower limb
Sites / Locations
- Chung Shan Medical University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
virtual reality-cycling training system
Arm Description
Outcomes
Primary Outcome Measures
pedal force of affected leg
Secondary Outcome Measures
asymmetrical ratio index
Full Information
NCT ID
NCT02069691
First Posted
February 17, 2014
Last Updated
February 20, 2014
Sponsor
Chung Shan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02069691
Brief Title
The Cycling Exercise With Virtual Reality Visual Stimulation for Rehabilitation in CVA Patients
Official Title
Institutional Review Board of Chung Shan Medical University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Hemiplegia is one of the main reasons why stroke survivors lose their walking and balancing ability. Many studies point out that cycling is an effective means for lower limb rehabilitation. However, during training, the unaffected limb may compensate for the affected one resulting in suboptimal rehabilitation. To address this issue, the investigators developed the virtual reality-cycling training system (VRCTS) which can acquire force and speed signals in real-time through a cycling module. The system then analyzes the acquired data and uses a 3D VR rehabilitation program to help patients to train their affected side. The aim of the study was to develop the VRCTS, verify its function and test system function on both normal subjects and stroke patients.
Methods: In this system, the investigators designed a cycling device that is embedded with load cell and encoder sensors to detect cycling force and angle in real-time. A Cycling Graph User Interface Control and Data Recode System (Cycling CR System) was applied for signal analysis and feedback control. The investigators designed a 3D interactive VR rehabilitation program that can guide and train the users through visual feedback. Each user performed a pre-test to examine determine condition, left-right balance and other parameters, which allows the system to be customized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke,, rehabilitation,, leg cycling,, feedback,, virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
virtual reality-cycling training system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
virtual reality-cycling training system
Primary Outcome Measure Information:
Title
pedal force of affected leg
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
asymmetrical ratio index
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
single stroke with unilateral hemiplegia (Brunnstrom stage III);
hypertonia in the affected leg, modified Ashworth scale (MAS) grade ≦ 2;
no significant perceptual, cognitive, or sensory deficits;
no history of osteoarthritis, severe cardiopulmonary disease, or vascular disease in lower limbs
lack of a fixed contracture in the affected lower limb
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
http://www.csh.org.tw/IRB/Index.htm
Description
CSMUH IRB
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The Cycling Exercise With Virtual Reality Visual Stimulation for Rehabilitation in CVA Patients
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