HemiparesisNCT02699398
Domiciliary VR Rehabilitation
A study testing Domiciliary VR-based motor rehabilitation and Domiciliary occupational therapy for motor rehabilitation in people with Hemiparesis and Functional Independence, run by Universitat Pompeu Fabra.
Trial summary
The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Hemiparesis, Functional Independence, Movement Disorder
- What is being tested?
- Domiciliary VR-based motor rehabilitation and Domiciliary occupational therapy for motor rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jul 2013
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Hemorrhagic or ischemic stroke
- Subject had the stroke more than 12 months ago.
- Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale>2) secondary to a first-ever stroke.
- Age between 45 and 85 years old.
- Subject has previous experience using the RGS system in the clinic.
Who cannot join
- Subject presents a major cognitive impairment (Mini-Mental State Evaluation> 22).
About this study
The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.
- Conditions
- Hemiparesis, Functional Independence, Movement Disorder, Stroke
- Being tested
- Domiciliary VR-based motor rehabilitation, Domiciliary occupational therapy for motor rehabilitation
- Medical subject headings
- Paresis, Movement Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Domiciliary VR-based motor rehabilitationBehavioural
3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.
Domiciliary occupational therapy for motor rehabilitationBehavioural
3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.
| Study group | Role | What they receive |
|---|---|---|
| VR-based therapy | Experimental | 3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup. Receives: Behavioral: Domiciliary VR-based motor rehabilitation |
| Control | Active comparator | 3 weeks of home-based occupational therapy for motor training. Receives: Behavioral: Domiciliary occupational therapy for motor rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical
Measured: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Secondary outcomes (7)
Change in depression as measured by the Hamilton scale
Measured: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in motor function as measured by the Medical Research Council scale
Measured: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in spasticity for the upper arms as measured by the Ashworth scale
Measured: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in cognitive function as measured by the Mini-mental State Evaluation test
Measured: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in Grip Force as measured by a grip dynamometer
Measured: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in shoulder pain as measured by the Visual Analog Assessment scale
Measured: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in motor function as measured by the upper extremity Fugl-Meyer Assessment
Measured: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionJul 2013
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 HemiparesisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Pompeu Fabra
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Mar, Hospital Vall d'Hebron
- Responsible party
- Principal investigator, Paul Verschure, Universitat Pompeu Fabra
- Investigators
- Paul Verschure, PhD, Principal investigator, Synthetic Perceptive, Emotive and Cognitive Systems group, Department of Information and Communication Technologies at the Universitat Pompeu Fabra (UPF).
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699398
- Sponsor's protocol ID
- AAL-2008-1-1191
- Status last verified
- Feb 2016
- First submitted
- 25 Feb 2016
- Last updated
- 4 Mar 2016
- Results posted
- No
Publications
Ballester BR, Nirme J, Camacho I, Duarte E, Rodriguez S, Cuxart A, Duff A, Verschure PFMJ. Domiciliary VR-Based Therapy for Functional Recovery and Cortical Reorganization: Randomized Controlled Trial in Participants at the Chronic Stage Post Stroke. JMIR Serious Games. 2017 Aug 7;5(3):e15. doi: 10.2196/games.6773.
PubMed 28784593
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domiciliary VR Rehabilitation
- ClinicalTrials.gov ID
- NCT02699398
- Acronym / sponsor ID
- AAL-2008-1-1191
- Conditions
- Hemiparesis, Functional Independence, Movement Disorder, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universitat Pompeu FabraUniversity, hospital or other
- Collaborators
- Hospital del Mar, Hospital Vall d'Hebron
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Mar 2016 (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 determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-based therapy | Experimental | Behavioral: Domiciliary VR-based motor rehabilitation3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup. |
| Control | Active comparator | Behavioral: Domiciliary occupational therapy for motor rehabilitation3 weeks of home-based occupational therapy for motor training. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of Hemorrhagic or ischemic stroke
- Subject had the stroke more than 12 months ago.
- Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale>2) secondary to a first-ever stroke.
- Age between 45 and 85 years old.
- Subject has previous experience using the RGS system in the clinic.
Key exclusion criteria (1 listed)
- Subject presents a major cognitive impairment (Mini-Mental State Evaluation> 22).
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 |
|---|---|---|
| Domiciliary VR-based motor rehabilitation3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system. | Behavioural | VR-based therapy |
| Domiciliary occupational therapy for motor rehabilitation3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system. | Behavioural | Control |
Primary outcome
Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical
Time frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
7 secondary outcomes
Change in depression as measured by the Hamilton scale
Time frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in motor function as measured by the Medical Research Council scale
Time frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in spasticity for the upper arms as measured by the Ashworth scale
Time frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in cognitive function as measured by the Mini-mental State Evaluation test
Time frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in Grip Force as measured by a grip dynamometer
Time frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in shoulder pain as measured by the Visual Analog Assessment scale
Time frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in motor function as measured by the upper extremity Fugl-Meyer Assessment
Time frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
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 4 Mar 2016.
- Derived from this study: PubMed 28784593Ballester BR, Nirme J, Camacho I, Duarte E, Rodriguez S, Cuxart A, Duff A, Verschure PFMJ. Domiciliary VR-Based Therapy for Functional Recovery and Cortical Reorganization: Randomized Controlled Trial in Participants at the Chronic Stage Post Stroke. JMIR Serious Games. 2017 Aug 7;5(3):e15. doi: 10.2196/games.6773.
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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.
Paul Verschure, PhD principal investigator
Synthetic Perceptive, Emotive and Cognitive Systems group, Department of Information and Communication Technologies at the Universitat Pompeu Fabra (UPF).
Questions about this trial
What is this clinical trial studying?
A study testing Domiciliary VR-based motor rehabilitation and Domiciliary occupational therapy for motor rehabilitation in people with Hemiparesis and Functional Independence, run by Universitat Pompeu Fabra.
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 1 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 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical (time frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.). 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 NCT02699398, 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 4 Mar 2016; AzTrials last refreshed its copy on 29 Oct 2026.