StrokePhase 2NCT00600379
Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke
A Phase 2 study testing Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands). in people with Stroke, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Oct 2010
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Main Inclusion Criteria:
- Stroke within 3-72 months.
- Mild-to-moderate residual gait deficits after the index stroke with preserved capacity for ambulation without or with an assistive device (e.g., walker, cane) or orthotics (e.g. AFO).
Main exclusion Criteria:
- Unstable cardiac or other medical condition or aphasia, dementia or other significant neurological disease limiting ability to train.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Virtual Reality Training Program for Ambulatory Patients With Mild-to-moderate Chronic Gait Deficits After Stroke
The purpose of this study is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.
Read the detailed description
Virtual reality (VR) systems enable the learning of simple and complex skills in a controlled virtual environment; i.e., one in which the different components (constraints) of the environment can be displayed, graded, changed and monitored in a quantitative manner.
Small preliminary studies suggest that VR may be used to augment chronic stroke rehabilitation and may enhance cortical reorganization. Our aim is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke. Study design-a single center randomized controlled trial of an experimental group and a usual care group.
- Conditions
- Stroke
- Being tested
- Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).
- Keywords
- stroke chronic gait deficits virtual reality training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).Device
Training 2/w for 9 weeks (total 18 sessions).
| Study group | Role | What they receive |
|---|---|---|
| A, | Experimental | Virtual Reality training for an overall of 18 sessions 2/week + usual care. Receives: Device: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands). |
| B, | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community ambulation using Step Activity Monitor (SAM)
Measured: Baseline X2, post training (week 9-10), retention (week 20-24)
Gait analysis (GaitRite system) including dual task
Measured: Baseline X2, post training (week 9-10), retention (week 20-24)
Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform.
Measured: Baseline X2, post training (week 9-10), retention (week 20-24)
Timed Up and Go
Measured: Baseline X2, post training (week 9-10), retention (week 20-24)
Secondary outcomes (5)
Functional Reach
Measured: Baseline X2, post training (week 9-10), retention (week 20-24)
Four Stick Stepping Test (FSST)
Measured: Baseline X2, post training (week 9-10), retention (week 20-24)
3DGait Analysis system
Measured: Baseline X2, post training (week 9-10), retention (week 20-24)
6 minute walk
Measured: Baseline X2, post training (week 9-10), retention (week 20-24)
Self-induced perturbations and reaction to perturbations on platform
Measured: Baseline X2, post training (week 9-10), retention (week 20-24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- David Tanne, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600379
- Sponsor's protocol ID
- SHEBA-07-4780-DT-CTIL
- Status last verified
- Jun 2011
- First submitted
- 14 Jan 2008
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Virtual Reality Training Program for Ambulatory Patients With Mild-to-moderate Chronic Gait Deficits After Stroke
- ClinicalTrials.gov ID
- NCT00600379
- Acronym / sponsor ID
- SHEBA-07-4780-DT-CTIL
- Conditions
- Stroke
- Keywords
- stroke chronic gait deficits virtual reality training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Jan 2008 (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.
The purpose of this study is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.
Detailed description
Virtual reality (VR) systems enable the learning of simple and complex skills in a controlled virtual environment; i.e., one in which the different components (constraints) of the environment can be displayed, graded, changed and monitored in a quantitative manner.
Small preliminary studies suggest that VR may be used to augment chronic stroke rehabilitation and may enhance cortical reorganization. Our aim is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke. Study design-a single center randomized controlled trial of an experimental group and a usual care group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, | Experimental | Device: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).Virtual Reality training for an overall of 18 sessions 2/week + usual care. |
| B, | No intervention | –Usual care |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).Training 2/w for 9 weeks (total 18 sessions). | Device | A, |
Primary outcome
Community ambulation using Step Activity Monitor (SAM)
Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)
Gait analysis (GaitRite system) including dual task
Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)
Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform.
Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)
Timed Up and Go
Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)
5 secondary outcomes
Functional Reach
Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)
Four Stick Stepping Test (FSST)
Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)
3DGait Analysis system
Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)
6 minute walk
Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)
Self-induced perturbations and reaction to perturbations on platform
Time frame: Baseline X2, post training (week 9-10), retention (week 20-24)
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 16 Jun 2011.
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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.
David Tanne, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands). in people with Stroke, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Jun 2011. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Community ambulation using Step Activity Monitor (SAM) (time frame: Baseline X2, post training (week 9-10), retention (week 20-24)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2011.