Acquired Brain Injury Including StrokeNCT02762058
Virtual Reality Mirror Therapy for Those With Acquired Brain Injury: A Clinical Pilot Study
A study testing Virtual Reality Mirror Therapy and Traditional Mirror Therapy in people with Acquired Brain Injury Including Stroke, run by University of Guelph.
Trial summary
The goal of this study is to investigate the effects of virtual reality based mirror therapy (VMT) on individuals with acquired brain injury when compared to a control group receiving traditional mirror therapy (TMT). Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Acquired Brain Injury Including Stroke
- What is being tested?
- Virtual Reality Mirror Therapy and Traditional Mirror Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of stroke or brain injury, including ischemic or hemorrhagic strokes, confirmed by radio logical evidence and evidence suggesting injury primarily to one side and exhibited by hemiplegia
- their post injury time is between 2 weeks and 2 years
- patients are between the age of 16 and 65 years old
Who cannot join
- greater than stage 4 on the CMSA
- behavioral impairments that may prevent safe or consistent participation
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this study is to investigate the effects of virtual reality based mirror therapy (VMT) on individuals with acquired brain injury when compared to a control group receiving traditional mirror therapy (TMT). This is a randomized controlled pilot study in which patients with hemiplegia will be assigned to VMT or TMT and the impact on upper extremity function will be observed.
Read the detailed description
The investigators are currently running a mirror therapy pilot project in the Hamilton Health Sciences Rehabilitation Program. Mirror therapy has been successfully used with people that have injuries such as strokes or other types of brain injuries that affect movement on one side of their body. Mirror therapy involves placing a mirror over the affected limb and angling it to reflect the unaffected limb. This creates a visual illusion that moving the unaffected limb also results in movement in the affected limb. This is theorized to aid recovery of the motor system in the brain. Virtual Reality (VR) can also be used with people with strokes and brain injuries and many studies of VR have shown positive results. In this study, the investigators will combine VR and mirror therapy. The investigators have designed a special new system that uses VR headset to make it appear that both limbs are moving when only the unaffected limb is moving. The investigators are going to do this by having people complete virtual tasks wearing this specially programmed headset. The tasks are everyday activities that a person might perform using two hands. Ultimately, the investigators hope to determine whether there is any difference between VR mirror therapy and regular mirror therapy in improving upper limb function.
- Conditions
- Acquired Brain Injury Including Stroke
- Being tested
- Virtual Reality Mirror Therapy, Traditional Mirror Therapy
- Keywords
- Acquired Brain Injury, Stroke Rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Mirror TherapyDevice
Also called VMT, Occulus Rift, Microsoft Kinect
Virtual Reality Mirror Therapy system using occulus rift as virtual headset and kinect as motion tracking sensor.
Traditional Mirror TherapyProcedure or surgery
Also called Mirror Therapy
Traditional Mirror Therapy system consisting of a mirror in which patients view their healthy limb over the affected to trick brain during dual motion tasks. This therapy has been shown to improve upper extremity function in patients with acquired brain injury.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients receiving Virtual Reality Mirror Therapy Receives: Device: Virtual Reality Mirror Therapy |
| Control Group | Experimental | Patients receiving Traditional Mirror Therapy Receives: Procedure: Traditional Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Function
To measure subjects upper extremity function via assessment scores pre and post treatment.
Measured: 6-weeks
Secondary outcomes (1)
Upper Extremity Range of Motion
Arm position data recorded through the VR systems measured in millimeters.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury Including 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Principal investigator, Laura MacNeil, University of Guelph
- Investigators
- Hussein Abdullah, PhD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762058
- Sponsor's protocol ID
- 1227
- Status last verified
- May 2016
- First submitted
- 28 Apr 2016
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Mirror Therapy for Those With Acquired Brain Injury: A Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT02762058
- Acronym / sponsor ID
- 1227
- Conditions
- Acquired Brain Injury Including Stroke
- Keywords
- Acquired Brain Injury, Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Natural Sciences and Engineering Research Council, Canada
- Study start
- Jun 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 4 May 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 goal of this study is to investigate the effects of virtual reality based mirror therapy (VMT) on individuals with acquired brain injury when compared to a control group receiving traditional mirror therapy (TMT). This is a randomized controlled pilot study in which patients with hemiplegia will be assigned to VMT or TMT and the impact on upper extremity function will be observed.
Detailed description
The investigators are currently running a mirror therapy pilot project in the Hamilton Health Sciences Rehabilitation Program. Mirror therapy has been successfully used with people that have injuries such as strokes or other types of brain injuries that affect movement on one side of their body. Mirror therapy involves placing a mirror over the affected limb and angling it to reflect the unaffected limb. This creates a visual illusion that moving the unaffected limb also results in movement in the affected limb. This is theorized to aid recovery of the motor system in the brain. Virtual Reality (VR) can also be used with people with strokes and brain injuries and many studies of VR have shown positive results. In this study, the investigators will combine VR and mirror therapy. The investigators have designed a special new system that uses VR headset to make it appear that both limbs are moving when only the unaffected limb is moving. The investigators are going to do this by having people complete virtual tasks wearing this specially programmed headset. The tasks are everyday activities that a person might perform using two hands. Ultimately, the investigators hope to determine whether there is any difference between VR mirror therapy and regular mirror therapy in improving upper limb function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Virtual Reality Mirror TherapyPatients receiving Virtual Reality Mirror Therapy |
| Control Group | Experimental | Procedure: Traditional Mirror TherapyPatients receiving Traditional Mirror Therapy |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of stroke or brain injury, including ischemic or hemorrhagic strokes, confirmed by radio logical evidence and evidence suggesting injury primarily to one side and exhibited by hemiplegia
- their post injury time is between 2 weeks and 2 years
- patients are between the age of 16 and 65 years old
Key exclusion criteria (2 listed)
- greater than stage 4 on the CMSA
- behavioral impairments that may prevent safe or consistent participation
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 Mirror TherapyAlso: VMT, Occulus Rift, Microsoft KinectVirtual Reality Mirror Therapy system using occulus rift as virtual headset and kinect as motion tracking sensor. | Device | Experimental Group |
| Traditional Mirror TherapyAlso: Mirror TherapyTraditional Mirror Therapy system consisting of a mirror in which patients view their healthy limb over the affected to trick brain during dual motion tasks. This therapy has been shown to improve upper extremity function in patients with acquired brain injury. | Procedure or surgery | Control Group |
Primary outcome
Upper Extremity Function
Time frame: 6-weeks
To measure subjects upper extremity function via assessment scores pre and post treatment.
1 secondary outcome
Upper Extremity Range of Motion
Time frame: 6-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Hussein Abdullah, PhD principal investigator
University of Guelph
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Mirror Therapy and Traditional Mirror Therapy in people with Acquired Brain Injury Including Stroke, run by University of Guelph.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denise Johnson, BHSc(PT) ((905)521-2100, johnsden@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Function (time frame: 6-weeks). 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 4 May 2016.