Mirror Box Imaging Study

Effects of Mirror Box Therapy on Neuroplasticity and Functional Outcome in Hemiparetic Upper Limb Post Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Mirror Box therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Essex
    • Westcliff on Sea, Essex, United Kingdom, SS0 0RY
      • Southend Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in brain connectivity will be assessed by resting-state fMRI	Baseline, 3 weeks and at 6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mid and South Essex NHS Foundation Trust
• Collaborators: Anglia Ruskin University
• Investigators: Principal Investigator: Iris Grunwald, Anglia Ruskin University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: P0868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No