Mirror Box Imaging Study

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Mirror Box therapy

• Registration Number: NCT02776306
• Lead Sponsor: Mid and South Essex NHS Foundation 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.

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-05-16
• Study First Posted: 2016-05-18
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mirror box therapy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Function of the affected hemiplegic upper limb will be assessed with action research arm test	Baseline, 3 weeks and at 6 weeks
Activity of daily living will be assessed with Barthel index.	Baseline, 3 weeks and at 6 weeks
Grip strength will be assessed using hand dynamometer	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

Trial Locations

Locations (1)

Southend Hospital; 🇬🇧 Westcliff on Sea, Essex, United Kingdom