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Completed

NCT Number: NCT02776306

Mirror Box Imaging Study

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.

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Key information

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southend Hospital

Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mirror Box therapy

Other

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.

Primary outcomes

  1. Change in brain connectivity will be assessed by resting-state fMRI

    Time frame: Baseline, 3 weeks and at 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mid and South Essex NHS Foundation Trust

Other

Collaborators

  • Anglia Ruskin University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
May 18, 2016
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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