NCT02762058

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

April 28, 2016

Last Update Submit

May 3, 2016

Conditions

Keywords

Acquired Brain InjuryStroke Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Upper Extremity Function

    To measure subjects upper extremity function via assessment scores pre and post treatment.

    6-weeks

Secondary Outcomes (1)

  • Upper Extremity Range of Motion

    6-weeks

Other Outcomes (1)

  • Mean Average Response Time

    6-weeks

Study Arms (2)

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

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

Also known as: VMT, Occulus Rift, Microsoft Kinect
Experimental Group

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.

Also known as: Mirror Therapy
Control Group

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Hussein Abdullah, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Johnson, BHSc(PT)

CONTACT

Bonnie Buchko

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Masters Student

Study Record Dates

First Submitted

April 28, 2016

First Posted

May 4, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

May 4, 2016

Record last verified: 2016-05