Spinal Cord InjuryNCT02149186
Interactive Motor Imagery in Virtual Reality
A study testing iCTuS-L in people with Spinal Cord Injury and Stroke, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Spinal Cord Injury, Stroke
- What is being tested?
- iCTuS-L
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2009to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any disease limiting training
- epilepsy
- major depression or psychosis
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spinal Cord Injury, Stroke
- Being tested
- iCTuS-L
- Medical subject headings
- Spinal Cord Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCTuS-LDevice
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation | Experimental | Not described Receives: Device: iCTuS-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startOct 2009
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149186
- Sponsor's protocol ID
- EK-24 2009/PB_2016-00545
- Status last verified
- Dec 2019
- First submitted
- 24 Apr 2014
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29234302
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Motor Imagery in Virtual Reality
- ClinicalTrials.gov ID
- NCT02149186
- Acronym / sponsor ID
- EK-24 2009/PB_2016-00545
- Conditions
- Spinal Cord Injury, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation | Experimental | Device: iCTuS-L |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- any disease limiting training
- epilepsy
- major depression or psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCTuS-L | Device | Rehabilitation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Derived from this study: PubMed 29234302Villiger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCTuS-L in people with Spinal Cord Injury and Stroke, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensorimotor Assessment (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02149186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.