Mirror Box Imaging Study

NCT ID: NCT02776306

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2022-04-01

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mirror Box therapy

Intervention Type: 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.

Standard treatment group

The participants will receive the standard treatment arm for 3 weeks for upper limb rehabilitation post stroke.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anglia Ruskin University

OTHER

Sponsor Role: collaborator

Mid and South Essex NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iris Grunwald

Role: PRINCIPAL_INVESTIGATOR

Anglia Ruskin University

Locations

Southend Hospital

Westcliff-on-Sea, Essex, United Kingdom

Countries

United Kingdom

Other Identifiers

P0868

Identifier Type: -

Identifier Source: org_study_id