Virtual Reality Mirror Therapy for Those With Acquired Br... | NCT02762058

Studies
Virtual Reality Mirror Therapy for Those With Acquired Brain Injury: A Clinical Pilot Study

NCT02762058

Sponsor

University of Guelph

Status

Unknown status

Last Update Posted

May 4, 2016Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Acquired Brain Injury Including Stroke

Interventions

Virtual Reality Mirror Therapy
Traditional Mirror Therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Apr 28, 2016

First Submission Date that Met QC Criteria

May 3, 2016

First Posted Date

May 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2016

Last Update Posted Date

May 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laura MacNeil, Masters Student, University of GuelphPrincipal Investigator

Lead Sponsor

University of GuelphOTHER

Collaborators

Name	Class
Hamilton Health Sciences Corporation	OTHER
Natural Sciences and Engineering Research Council, Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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). 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group	Experimental	Patients receiving Virtual Reality Mirror Therapy	Device: Virtual Reality Mirror Therapy
Control Group	Experimental	Patients receiving Traditional Mirror Therapy	Procedure: Traditional Mirror Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Reality Mirror Therapy	Device	Virtual Reality Mirror Therapy system using occulus rift as virtual headset and kinect as motion tracking sensor.	Experimental Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Upper Extremity Function	To measure subjects upper extremity function via assessment scores pre and post treatment.	6-weeks

Secondary Outcomes

Measure	Description	Time Frame
Upper Extremity Range of Motion	Arm position data recorded through the VR systems measured in millimeters.	6-weeks

Other Outcomes

Measure	Description	Time Frame
Mean Average Response Time	Mean average response time to complete tasks measured in seconds.	6-weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

greater than stage 4 on the CMSA
behavioral impairments that may prevent safe or consistent participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Denise Johnson, BHSc(PT)	Contact	(905)521-2100		johnsden@hhsc.ca
Bonnie Buchko	Contact	(905)521-2100		buchkbon@hhsc.ca

Overall Officials

Name	Affiliation	Role
Hussein Abdullah, PhD	University of Guelph	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000088762	Mirror Movement Therapy

Ancestor Terms

ID	Term
D026741	Physical Therapy Modalities
D012046	Rehabilitation
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided