HemiparesisNCT02657070
Counteracting Learned Non-use Through Augmented Visuomotor Feedback in Virtual Reality (RGS)
A study testing Reinforcement-Induced Movement Therapy (RIMT) and VR-based motor rehabilitation in RGS without augmented feedback in people with Hemiparesis, run by Universitat Pompeu Fabra.
Trial summary
The purpose of this study is to determine if Reinforcement-Induced Movement Therapy (RIMT), a novel rehabilitation method that augments visuomotor feedback of movements of the patient in virtual reality, is effective in treating hemiparesis resp. learned non-use. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hemiparesis
- What is being tested?
- Reinforcement-Induced Movement Therapy (RIMT) and VR-based motor rehabilitation in RGS without augmented feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Aug 2015
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild-to-moderate upper-limbs hemiparesis (Proximal Medical Research Council Scale > 2) due to ischemic or hemorrhagic stroke
- Spasticity in the affected limb (Modified Ashworth Scale <3)
- First-ever ischemic or hemorrhagic stroke (>4 weeks post-stroke)
- Sufficient cognitive capacity for following the instruction of the intervention (Mini-Mental State Evaluation >24)
Who cannot join
- Cognitive impairment that impede the correct execution or understanding of the intervention
- Severe impairments in vision or visual perception abilities (such as vision loss or spatial neglect), in spasticity, in communication abilities (such as aphasia or apraxia), severe pain as well as other neuromuscular or orthopedic changes that impede the correct execution of the intervention training
- Mental dysfunctioning during the acute or subacute phase after the stroke.
About this study
Official title: Desaprendiendo la parálisis Aprendida Con RGS en Pacientes Afectos de Ictus
The purpose of this study is to determine if Reinforcement-Induced Movement Therapy (RIMT), a novel rehabilitation method that augments visuomotor feedback of movements of the patient in virtual reality, is effective in treating hemiparesis resp. learned non-use.
- Conditions
- Hemiparesis
- Being tested
- Reinforcement-Induced Movement Therapy (RIMT), VR-based motor rehabilitation in RGS without augmented feedback
- Keywords
- Stroke, learned non-use, Virtual Reality, Hemiparesis
- Medical subject headings
- Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforcement-Induced Movement Therapy (RIMT)Behavioural
Also called VR-based motor rehabilitation in RGS with amplified visuomotor feedback
6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS) with augmented visuomotor feedback
VR-based motor rehabilitation in RGS without augmented feedbackBehavioural
6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Virtual reality based therapy with augmented visuomotor feedback. Receives: Behavioral: Reinforcement-Induced Movement Therapy (RIMT) |
| Control Group | Active comparator | Virtual reality based therapy without augmentation. Receives: Behavioral: VR-based motor rehabilitation in RGS without augmented feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
The upper extremity Fugl-Meyer Assessment
change from baseline in motor function
Measured: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
Secondary outcomes (3)
Chedoke Arm Hand Inventory
change from baseline in functional recovery
Measured: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
Barthel Index
change from baseline in activities of daily living
Measured: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
Hamilton Scale
change from baseline in measurement of depression
Measured: at baseline, at 6-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 posted15 Jan 2016 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Pompeu Fabra
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona.
- Responsible party
- Principal investigator, Paul Verschure, Universitat Pompeu Fabra
- Investigators
- Rosa Maria San Segundo Mozo, Dra., Principal investigator, Medico Especialista en Medician Fisica y Rehabilitation, Doctora por al Universitat Rovira i Virgili de TarragonaPaul F.M.J. Verschure, Prof., Study director, Director SPECS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657070
- Sponsor's protocol ID
- CEIC 53/2013
- Status last verified
- Jan 2016
- First submitted
- 13 Jan 2016
- Last updated
- 15 Jan 2016
- Results posted
- No
Publications
Ramachandran VS, Rogers-Ramachandran D. Phantom limbs and neural plasticity. Arch Neurol. 2000 Mar;57(3):317-20. doi: 10.1001/archneur.57.3.317.
PubMed 10714655de Haan RJ, Limburg M, Van der Meulen JH, Jacobs HM, Aaronson NK. Quality of life after stroke. Impact of stroke type and lesion location. Stroke. 1995 Mar;26(3):402-8. doi: 10.1161/01.str.26.3.402.
PubMed 7886714Thomas SA, Lincoln NB. Factors relating to depression after stroke. Br J Clin Psychol. 2006 Mar;45(Pt 1):49-61. doi: 10.1348/014466505X34183.
PubMed 16480566Robinson RG, Jorge RE. Post-Stroke Depression: A Review. Am J Psychiatry. 2016 Mar 1;173(3):221-31. doi: 10.1176/appi.ajp.2015.15030363. Epub 2015 Dec 18.
PubMed 26684921Ballester BR, Maier M, San Segundo Mozo RM, Castaneda V, Duff A, M J Verschure PF. Counteracting learned non-use in chronic stroke patients with reinforcement-induced movement therapy. J Neuroeng Rehabil. 2016 Aug 9;13(1):74. doi: 10.1186/s12984-016-0178-x.
PubMed 27506203
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desaprendiendo la parálisis Aprendida Con RGS en Pacientes Afectos de Ictus
- ClinicalTrials.gov ID
- NCT02657070
- Acronym / sponsor ID
- CEIC 53/2013
- Conditions
- Hemiparesis
- Keywords
- Stroke, learned non-use, Virtual Reality, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universitat Pompeu FabraUniversity, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona.
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Jan 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 if Reinforcement-Induced Movement Therapy (RIMT), a novel rehabilitation method that augments visuomotor feedback of movements of the patient in virtual reality, is effective in treating hemiparesis resp. learned non-use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Reinforcement-Induced Movement Therapy (RIMT)Virtual reality based therapy with augmented visuomotor feedback. |
| Control Group | Active comparator | Behavioral: VR-based motor rehabilitation in RGS without augmented feedbackVirtual reality based therapy without augmentation. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild-to-moderate upper-limbs hemiparesis (Proximal Medical Research Council Scale > 2) due to ischemic or hemorrhagic stroke
- Spasticity in the affected limb (Modified Ashworth Scale <3)
- First-ever ischemic or hemorrhagic stroke (>4 weeks post-stroke)
- Sufficient cognitive capacity for following the instruction of the intervention (Mini-Mental State Evaluation >24)
Key exclusion criteria (3 listed)
- Cognitive impairment that impede the correct execution or understanding of the intervention
- Severe impairments in vision or visual perception abilities (such as vision loss or spatial neglect), in spasticity, in communication abilities (such as aphasia or apraxia), severe pain as well as other neuromuscular or orthopedic changes that impede the correct execution of the intervention training
- Mental dysfunctioning during the acute or subacute phase after the stroke.
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 |
|---|---|---|
| Reinforcement-Induced Movement Therapy (RIMT)Also: VR-based motor rehabilitation in RGS with amplified visuomotor feedback6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS) with augmented visuomotor feedback | Behavioural | Experimental Group |
| VR-based motor rehabilitation in RGS without augmented feedback6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS) | Behavioural | Control Group |
Primary outcome
The upper extremity Fugl-Meyer Assessment
Time frame: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
change from baseline in motor function
3 secondary outcomes
Chedoke Arm Hand Inventory
Time frame: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
Barthel Index
Time frame: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
Hamilton Scale
Time frame: at baseline, at 6-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 15 Jan 2016.
- Background: PubMed 10714655Ramachandran VS, Rogers-Ramachandran D. Phantom limbs and neural plasticity. Arch Neurol. 2000 Mar;57(3):317-20. doi: 10.1001/archneur.57.3.317.
- Background: PubMed 7886714de Haan RJ, Limburg M, Van der Meulen JH, Jacobs HM, Aaronson NK. Quality of life after stroke. Impact of stroke type and lesion location. Stroke. 1995 Mar;26(3):402-8. doi: 10.1161/01.str.26.3.402.
- Background: PubMed 16480566Thomas SA, Lincoln NB. Factors relating to depression after stroke. Br J Clin Psychol. 2006 Mar;45(Pt 1):49-61. doi: 10.1348/014466505X34183.
- Background: PubMed 26684921Robinson RG, Jorge RE. Post-Stroke Depression: A Review. Am J Psychiatry. 2016 Mar 1;173(3):221-31. doi: 10.1176/appi.ajp.2015.15030363. Epub 2015 Dec 18.
- Derived from this study: PubMed 27506203Ballester BR, Maier M, San Segundo Mozo RM, Castaneda V, Duff A, M J Verschure PF. Counteracting learned non-use in chronic stroke patients with reinforcement-induced movement therapy. J Neuroeng Rehabil. 2016 Aug 9;13(1):74. doi: 10.1186/s12984-016-0178-x.
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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.
Rosa Maria San Segundo Mozo, Dra. principal investigator
Medico Especialista en Medician Fisica y Rehabilitation, Doctora por al Universitat Rovira i Virgili de Tarragona
Paul F.M.J. Verschure, Prof. study director
Director SPECS
Questions about this trial
What is this clinical trial studying?
A study testing Reinforcement-Induced Movement Therapy (RIMT) and VR-based motor rehabilitation in RGS without augmented feedback in people with Hemiparesis, 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 4 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 15 Jan 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?
The upper extremity Fugl-Meyer Assessment (time frame: at baseline, at 6-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 NCT02657070, which also lists 5 linked publications.
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 15 Jan 2016.