Clinical trial NCT02776306: Mirror Box Imaging Study
Official title: Effects of Mirror Box Therapy on Neuroplasticity and Functional Outcome in Hemiparetic Upper Limb Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Anglia Ruskin University
First posted: 2016-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in brain connectivity will be assessed by resting-state fMRI
timeFrame: Baseline, 3 weeks and at 6 weeks
Secondary outcomes:
measure: Activity of daily living will be assessed with Barthel index.
timeFrame: Baseline, 3 weeks and at 6 weeks
measure: Function of the affected hemiplegic upper limb will be assessed with action research arm test
timeFrame: Baseline, 3 weeks and at 6 weeks
measure: Impairment in the hemiplegic upper limb will be assessed with Fugl Meyer test.
timeFrame: Baseline, 3 weeks and at 6 weeks
measure: Grip strength will be assessed using hand dynamometer
timeFrame: Baseline, 3 weeks and at 6 weeks
Other outcomes:
Locations:
city: Westcliff on Sea
country: United Kingdom
facility: Southend Hospital
state: Essex
Study officials:
affiliation: Anglia Ruskin University
name: Iris Grunwald
role: PRINCIPAL_INVESTIGATOR
References: