- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02149186
Interactive Motor Imagery in Virtual Reality
January 6, 2020 updated by: University of Zurich
This project will build and test the first rehabilitation system employing virtual reality (VR)-based observation, motor imagery and execution to treat lower-limb neuropathic pain and motor dysfunction in participants with an incomplete spinal cord injury or another neurological disorder, eg.
stroke: iCTuS-L (Interactive Computer-based Therapy System for legs).
Patients using the system will control virtual representations of their legs to engage in entertaining gaming interactions.
Study Overview
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zurich, Switzerland, 8008
- Curt, Armin, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 16 and 80
- clinically incomplete spinal cord injury (time since injury: chronic > 1 year; acute < 3 months)
- ASI C or D
- neuropathic pain and/or motor deficits
- diagnosed neurological disorder, eg. stroke
Exclusion Criteria:
- any disease limiting training
- epilepsy
- major depression or psychosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensorimotor Assessment
Time Frame: 16 weeks
|
Questionnaire assessing distinct pain qualities associated with neuropathic pain, structured pain interview, questionnaire for assessing patients diagnosed as depressed and detects depression among the normal population, transcutaneous electrical stimulation of superficial nerves, information about the motor level of the lesion, the sensory levels of the lesion (light touch and pin prick), questionnaire assessing activities of daily life and independence in subjects with spinal cord lesion, walking aids and/or personal assistance, examining gait speed, transcranial magnetic stimulation
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2009
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
April 24, 2014
First Submitted That Met QC Criteria
May 23, 2014
First Posted (Estimate)
May 29, 2014
Study Record Updates
Last Update Posted (Actual)
January 7, 2020
Last Update Submitted That Met QC Criteria
January 6, 2020
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK-24 2009/PB_2016-00545
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.