Ischaemic StrokePhase 3NCT02073773
Combinational Rehabilitative Therapy and Functional Brain Imaging for Patients Recovering From Motor Stroke
A Phase 3 study testing Levodopa and Virtual Reality based therapy in people with Ischaemic Stroke, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The present proposal aims to assess whether a combined rehabilitation approach using virtual reality based therapy with motivational feedback, levodopa for pharmacotherapy and standard rehabilitative occupational therapy and physiotherapy will lead to signifcantly better outcomes for stroke recovery. Read more about this study
- Who is it for?
- Ages 25 to 99 years
- Conditions the study is for
- Ischaemic Stroke
- What is being tested?
- Levodopa and Virtual Reality based therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2014to Nov 2015
- Phase
- Phase 3
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 25-99yrs
- Right-handed
- Cognitively coherent, able to provide informed consent (MMSE >25)
- Newly diagnosed, first episode ischemic stroke in the past 2-21 days
- Motor score: Strength of 2-3 out of 5 on affected side upper limb
Who cannot join
- Declined consent to participate in the study
- Cognitive impairment or significant aphasia with inability to understand study requirements and inability to participate in therapy
- Other neurological or physical ailments with pre-existing motor weakness
- Haemorrhagic stroke
- Patient due to undergo significant medical interventions such as carotid endarthrectomy
- Patients on neuroactive agents prior to the stroke such as antidepressants
Show all 12Show fewer
- Hypersensitivity to benserazide, levodopa, sympathomimetics, or any component of the formulation
- Use of MAO inhibitors within the last 14 days
- Patients with clinical or laboratory evidence of uncompensated cardiovascular, endocrine, renal, hepatic, hematologic, or pulmonary disease
- Patients with decompensated endocrine, renal, hepatic, cardiac disorders, psychiatric disorders, narrow-angle glaucoma, or closed-angle glaucoma;
- Patients <25 years of age (due to possibility of skeletal abnormalities from benserazide)
- Pregnancy or use in women of childbearing potential without adequate contraception.
Trial locations and contacts
1 site in 1 country.
About this study
The present proposal aims to assess whether a combined rehabilitation approach using virtual reality based therapy with motivational feedback, levodopa for pharmacotherapy and standard rehabilitative occupational therapy and physiotherapy will lead to signifcantly better outcomes for stroke recovery.
It is a randomised controlled trial with blinding of the assessors only. It will be preceeded by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only. Recruited in-patient rehabilitation ward patients who have recently suffered stroke will be randomized, through a computer-based random number generator, to either one of two treatment arms:
- Control occupational therapy + pharmacotherapy for 2 weeks
- Assisted Virtual-Reality physiotherapy + pharmacotherapy for 2 weeks
Read the detailed description
The study is designed as a single-blinded randomized controlled trial, preceeded by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only.
Phase 1 will comprise of recruitment of up to 5 patients who have recently suffered a stroke who will be informed that they will receive ten 15- 30 minutes of VR therapy in addition to their standard stroke therapy. They will not receive any pharmacotherapy during this period. At the start and end of the VR phase, clinical assessment (Fugl-Meyer scores, Action Research Arm Test) will be made of each patient by a blinded clinician investigator.
From this data, calibration to the VR program will be made to ensure reproducibility of effectiveness of movements assessed.
Subsequently, for the main phase of the trial, recruited in-patients who have recently suffered stroke will be randomized, through a computer-based random number generator, to either one of two treatment arms:
- Control occupational therapy + pharmacotherapy
- Assisted Virtual-Reality physiotherapy + pharmacotherapy
Each patient will receive an initial functional Magnetic Resonace Imaging (fMRI) scan prior to the start of the study. The initial pilot single-centre study will be run in the Singapore General Hospital Rehabilitation Ward across a 2-week period, where participants will undergo daily 15-30 minute VR based therapy in addition to the physiotherapy/occupational therapy session they receive daily.
The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table.
Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before an additional half an hour of occupational therapy to the weaker arm or VR therapy session, depending on the assigned group.
At the start and end of the trial, clinical assessment (Fugl-Meyer scores, Action Research Arm Test and Functional Independence Measure) will be made of each patient by a blinded clinician investigator. At the final (10th) session, patients will undergo the final fMRI scan. MRI scans will be analysed by blinded assessors.
- Conditions
- Ischaemic Stroke
- Being tested
- Levodopa, Virtual Reality based therapy
- Keywords
- stroke, virtual reality based therapy
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevodopaDrug
Also called Madopar
Levodopa 100mg with benserazide 25mg will be administered 3 hours prior to the start of the daily PT/OT session to maximize its pharmacokinetic window ie. blood plasma levels in the narrow window during which functional rewiring of neural circuits is thought to occur.
Levodopa at the lowest available dose (100mg P.O qd) has been shown to improve motor function of stroke patients and their corresponding quality of life. The treatment proposed can be incorporated into their daily rehabilitation routine. Early intervention (within 7-21 days of the infarct) raises the chance for neuroplasticity and improved recovery of their motor function in the short and long run. Levodopa has been proven to be safe to be used in stroke patients (Lancet. 2001 Sep 8;358(9284):787-90., Arch Phys Med Rehabil. 2008 Sep;89(9):1633-41.), however, the side effects of this medication may include nausea, unusual tiredness, dizziness, excessive watering of mouth.
Virtual Reality based therapyOther
The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality based therapy, levodopa | Experimental | The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table.
Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before each additional Occupational therapy session or VR therapy session depending on the assigned group. Receives: Drug: Levodopa; Other: Virtual Reality based therapy |
| occupational therapy, levodopa | Active comparator | The control group will receive and additional half an hour per working day of standard occupational therapy.
Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before each additional Occupational therapy session or VR therapy session depending on the assigned group. Receives: Drug: Levodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Fugl Meyer Upper Limb score at the start and end of the two weeks trial period
Fugl Meyer Upper Extremity Scale (FM) - a clinical assessment of upper limb tone, power and movement.
Measured: At the start and end of the 2 weeks period of trial therapy
Secondary outcomes (2)
Changes in the Action Research Arm Test (ARAT)
an assessment tool of upper limb grasp, grip, pinch and gross movement.
Measured: At the start and end of the 2 weeks period of trial therapy
Changes in the Functional independence measure score
An assessment of ability to perform 13 different activites of daily living and an assessment fo 5 measures of cognition necessary for independence
Measured: At the start and end of the 2 weeks therapy period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic StrokeStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore University of Technology and Design
- Responsible party
- Sponsor
- Investigators
- Yee S NG, MBBS, MRCP, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073773
- Sponsor's protocol ID
- CIRB 2013/323/D
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combinational Rehabilitative Therapy and Functional Brain Imaging for Patients Recovering From Motor Stroke
- ClinicalTrials.gov ID
- NCT02073773
- Acronym / sponsor ID
- CIRB 2013/323/D
- Conditions
- Ischaemic Stroke
- Keywords
- stroke, virtual reality based therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Singapore University of Technology and Design
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Feb 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.
The present proposal aims to assess whether a combined rehabilitation approach using virtual reality based therapy with motivational feedback, levodopa for pharmacotherapy and standard rehabilitative occupational therapy and physiotherapy will lead to signifcantly better outcomes for stroke recovery.
It is a randomised controlled trial with blinding of the assessors only. It will be preceeded by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only. Recruited in-patient rehabilitation ward patients who have recently suffered stroke will be randomized, through a computer-based random number generator, to either one of two treatment arms:
- Control occupational therapy + pharmacotherapy for 2 weeks
- Assisted Virtual-Reality physiotherapy + pharmacotherapy for 2 weeks
Detailed description
The study is designed as a single-blinded randomized controlled trial, preceeded by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only.
Phase 1 will comprise of recruitment of up to 5 patients who have recently suffered a stroke who will be informed that they will receive ten 15- 30 minutes of VR therapy in addition to their standard stroke therapy. They will not receive any pharmacotherapy during this period. At the start and end of the VR phase, clinical assessment (Fugl-Meyer scores, Action Research Arm Test) will be made of each patient by a blinded clinician investigator.
From this data, calibration to the VR program will be made to ensure reproducibility of effectiveness of movements assessed.
Subsequently, for the main phase of the trial, recruited in-patients who have recently suffered stroke will be randomized, through a computer-based random number generator, to either one of two treatment arms:
- Control occupational therapy + pharmacotherapy
- Assisted Virtual-Reality physiotherapy + pharmacotherapy
Each patient will receive an initial functional Magnetic Resonace Imaging (fMRI) scan prior to the start of the study. The initial pilot single-centre study will be run in the Singapore General Hospital Rehabilitation Ward across a 2-week period, where participants will undergo daily 15-30 minute VR based therapy in addition to the physiotherapy/occupational therapy session they receive daily.
The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table.
Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before an additional half an hour of occupational therapy to the weaker arm or VR therapy session, depending on the assigned group.
At the start and end of the trial, clinical assessment (Fugl-Meyer scores, Action Research Arm Test and Functional Independence Measure) will be made of each patient by a blinded clinician investigator. At the final (10th) session, patients will undergo the final fMRI scan. MRI scans will be analysed by blinded assessors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality based therapy, levodopa | Experimental | Drug: Levodopa, Other: Virtual Reality based therapyThe VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table. Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before each additional Occupational therapy session or VR therapy session depending on the assigned group. |
| occupational therapy, levodopa | Active comparator | Drug: LevodopaThe control group will receive and additional half an hour per working day of standard occupational therapy. Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before each additional Occupational therapy session or VR therapy session depending on the assigned group. |
Who may qualify
- Ages
- 25 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 25-99yrs
- Right-handed
- Cognitively coherent, able to provide informed consent (MMSE >25)
- Newly diagnosed, first episode ischemic stroke in the past 2-21 days
- Motor score: Strength of 2-3 out of 5 on affected side upper limb
Key exclusion criteria (12 listed)
- Declined consent to participate in the study
- Cognitive impairment or significant aphasia with inability to understand study requirements and inability to participate in therapy
- Other neurological or physical ailments with pre-existing motor weakness
- Haemorrhagic stroke
- Patient due to undergo significant medical interventions such as carotid endarthrectomy
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 |
|---|---|---|
| LevodopaAlso: MadoparLevodopa 100mg with benserazide 25mg will be administered 3 hours prior to the start of the daily PT/OT session to maximize its pharmacokinetic window ie. blood plasma levels in the narrow window during which functional rewiring of neural circuits is thought to occur. Levodopa at the lowest available dose (100mg P.O qd) has been shown to improve motor function of stroke patients and their corresponding quality of life. The treatment proposed can be incorporated into their daily rehabilitation routine. Early intervention (within 7-21 days of the infarct) raises the chance for neuroplasticity and improved recovery of their motor function in the short and long run. Levodopa has been proven to be safe to be used in stroke patients (Lancet. 2001 Sep 8;358(9284):787-90., Arch Phys Med Rehabil. 2008 Sep;89(9):1633-41.), however, the side effects of this medication may include nausea, unusual tiredness, dizziness, excessive watering of mouth. | Drug | Virtual Reality based therapy, levodopa, occupational therapy, levodopa |
| Virtual Reality based therapyThe VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table. | Other | Virtual Reality based therapy, levodopa |
Primary outcome
Changes in the Fugl Meyer Upper Limb score at the start and end of the two weeks trial period
Time frame: At the start and end of the 2 weeks period of trial therapy
Fugl Meyer Upper Extremity Scale (FM) - a clinical assessment of upper limb tone, power and movement.
2 secondary outcomes
Changes in the Action Research Arm Test (ARAT)
Time frame: At the start and end of the 2 weeks period of trial therapy
Changes in the Functional independence measure score
Time frame: At the start and end of the 2 weeks therapy period
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 10 Feb 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.
Yee S NG, MBBS, MRCP principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levodopa and Virtual Reality based therapy in people with Ischaemic Stroke, run by Singapore General Hospital at 1 site in Singapore.
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 12 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 10 Feb 2017. 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 Singapore. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Changes in the Fugl Meyer Upper Limb score at the start and end of the two weeks trial period (time frame: At the start and end of the 2 weeks period of trial therapy). 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 10 Feb 2017.