Interactive Motor Imagery in Virtual Reality
Primary Purpose
Spinal Cord Injury, Stroke
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
iCTuS-L
Sponsored by
About this trial
This is an interventional basic science trial for Spinal Cord Injury
Eligibility Criteria
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
Sites / Locations
- Curt, Armin, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
Sensorimotor Assessment
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02149186
Brief Title
Interactive Motor Imagery in Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2009 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Stroke
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
iCTuS-L
Primary Outcome Measure Information:
Title
Sensorimotor Assessment
Description
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
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Curt, Armin, MD
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
29234302
Citation
Villiger M, Liviero J, Awai L, Stoop R, Pyk P, Clijsen R, Curt A, Eng K, Bolliger M. Home-Based Virtual Reality-Augmented Training Improves Lower Limb Muscle Strength, Balance, and Functional Mobility following Chronic Incomplete Spinal Cord Injury. Front Neurol. 2017 Nov 28;8:635. doi: 10.3389/fneur.2017.00635. eCollection 2017.
Results Reference
derived
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Interactive Motor Imagery in Virtual Reality
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