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Mirror Box Imaging Study

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ClinicalTrials.gov Identifier: NCT02776306
Recruitment Status : Unknown
Verified December 2016 by Southend University Hospital Foundation NHS Trust.
Recruitment status was:  Recruiting
First Posted : May 18, 2016
Last Update Posted : December 14, 2016
Sponsor:
Collaborator:
Anglia Ruskin University
Information provided by (Responsible Party):
Southend University Hospital Foundation NHS Trust

Brief Summary:
The purpose of this study is to evaluate the effects of mirror box therapy on upper extremity, motor recovery and motor functioning in patients that have suffered a stroke.

Condition or disease Intervention/treatment Phase
Stroke Other: Mirror Box therapy Not Applicable

Detailed Description:

Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors, with 30%-60% of patients being unable to fully recover functional use of their upper limbs. As recovery may be due to insufficient or inadequate therapeutic interventions, the progress and evaluation of upper limb treatment is currently being investigated.

Mirror Box therapy is a task orientated, non-invasive, economic and patient directed therapy for hemiparetic upper limb post stroke patients. The study is intended to evaluate cerebral reorganization by using mirror therapy. Movements of the stronger limb trick the brain into thinking that the weaker arm is moving and to stimulate the respective brain areas.

Patients are enrolled into two groups using standard upper limb rehabilitation for three weeks followed by standard rehabilitation plus Mirror Box for another three weeks (Group 1). Group 2 will receive the same therapy in inverted order.

Patients will receive clinical and functional assessment at baseline, three weeks and six weeks including brain MRI using functional resting state MRI.

The primary outcome is functional connectivity (correlation coefficient) at baseline and after treatment. Secondary endpoints include motor and functional recovery using outcome measures like Fugl Meyer assessment, Action Research Arm Test, grip and pincer strength. Further secondary endpoints are increase in sensorimotor cortex activation across the period of therapy and cortical reorganization.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Mirror Box Therapy on Neuroplasticity and Functional Outcome in Hemiparetic Upper Limb Post Stroke
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: Mirror box therapy
The participants in the mirror box therapy arm will receive mirror box therapy for 3 weeks for upper limb rehabilitation post stroke.
Other: Mirror Box therapy
In mirror box therapy the patient uses the reflection of their good arm to trick to brain into thinking that the effected arm is working.

No Intervention: Standard treatment group
The participants will receive the standard treatment arm for 3 weeks for upper limb rehabilitation post stroke.



Primary Outcome Measures :
  1. Change in brain connectivity will be assessed by resting-state fMRI [ Time Frame: Baseline, 3 weeks and at 6 weeks ]

Secondary Outcome Measures :
  1. Activity of daily living will be assessed with Barthel index. [ Time Frame: Baseline, 3 weeks and at 6 weeks ]
  2. Function of the affected hemiplegic upper limb will be assessed with action research arm test [ Time Frame: Baseline, 3 weeks and at 6 weeks ]
  3. Impairment in the hemiplegic upper limb will be assessed with Fugl Meyer test. [ Time Frame: Baseline, 3 weeks and at 6 weeks ]
  4. Grip strength will be assessed using hand dynamometer [ Time Frame: Baseline, 3 weeks and at 6 weeks ]


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Ages Eligible for Study:   18 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18yrs to 105yrs
  • Hemiparetic upper limb post stroke
  • Capable of providing informed consent
  • Intact vision: if diagnosis of peripheral field defect, patient should be able to compensate for it.

Exclusion Criteria:

  • Any contraindication to MRI scanning
  • Clinically significant psychiatric disorder (e.g. depression)
  • Pre-existing neurological or psychiatric disease that could confound the study results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776306


Contacts
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Contact: Susan Bowman 01702 385342 susan.bowman@southend.nhs.uk
Contact: Craig Mackerness 01702 385089 craig.mackerness@southend.nhs.uk

Locations
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United Kingdom
Southend University Hospital NHS FoundationTrust Recruiting
Westcliff on Sea, Essex, United Kingdom, SS0 0RY
Contact: Aarti Sharma    01702 435555 ext 6143    aarti.sharma@southend.nhs.uk   
Sponsors and Collaborators
Southend University Hospital Foundation NHS Trust
Anglia Ruskin University
Investigators
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Principal Investigator: Iris Grunwald Anglia Ruskin University

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Responsible Party: Southend University Hospital Foundation NHS Trust
ClinicalTrials.gov Identifier: NCT02776306     History of Changes
Other Study ID Numbers: P0868
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases