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

Acquired Brain Injury Including Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02762058
• Other study ID #: 1227
• Status: Not yet recruiting
• Phase: N/A
• First received: April 28, 2016
• Last updated: May 3, 2016
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: May 2016
• Source: University of Guelph
• Contact: Denise Johnson, BHSc(PT)
• Phone: (905)521-2100
• Email: johnsden[@]hhsc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Brain Injury Including Stroke
• Brain Injuries

Intervention

Device:
• Virtual Reality Mirror Therapy
Virtual Reality Mirror Therapy system using occulus rift as virtual headset and kinect as motion tracking sensor.

Procedure:
• Traditional 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Guelph	Hamilton Health Sciences Corporation, Natural Sciences and Engineering Research Council, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Average Response Time	Mean average response time to complete tasks measured in seconds.	6-weeks	No
Primary	Upper Extremity Function	To measure subjects upper extremity function via assessment scores pre and post treatment.	6-weeks	No
Secondary	Upper Extremity Range of Motion	Arm position data recorded through the VR systems measured in millimeters.	6-weeks	No