The Cycling Exercise With Virtual Reality Visual Stimulation for Rehabilitation in CVA Patients
Institutional Review Board of Chung Shan Medical University Hospital
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Aug 2012
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 24, 2014
CompletedFebruary 24, 2014
August 1, 2012
2 months
February 17, 2014
February 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pedal force of affected leg
up to 24 weeks
Secondary Outcomes (1)
asymmetrical ratio index
up to 24 weeks
Study Arms (1)
virtual reality-cycling training system
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- pofessor
Study Record Dates
First Submitted
February 17, 2014
First Posted
February 24, 2014
Study Start
August 1, 2012
Primary Completion
October 1, 2012
Study Completion
May 1, 2013
Last Updated
February 24, 2014
Record last verified: 2012-08