search
Back to results

Mirror Box Imaging Study

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mirror Box therapy
Sponsored by
Mid and South Essex NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southend Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mirror box therapy

Standard treatment group

Arm Description

The participants in the mirror box therapy arm will receive mirror box therapy for 3 weeks for upper limb rehabilitation post stroke.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Activity of daily living will be assessed with Barthel index.
Function of the affected hemiplegic upper limb will be assessed with action research arm test
Impairment in the hemiplegic upper limb will be assessed with Fugl Meyer test.
Grip strength will be assessed using hand dynamometer

Full Information

First Posted
April 7, 2016
Last Updated
May 30, 2022
Sponsor
Mid and South Essex NHS Foundation Trust
Collaborators
Anglia Ruskin University
search

1. Study Identification

Unique Protocol Identification Number
NCT02776306
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mid and South Essex NHS Foundation Trust
Collaborators
Anglia Ruskin University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror box therapy
Arm Type
Experimental
Arm Description
The participants in the mirror box therapy arm will receive mirror box therapy for 3 weeks for upper limb rehabilitation post stroke.
Arm Title
Standard treatment group
Arm Type
No Intervention
Arm Description
The participants will receive the standard treatment arm for 3 weeks for upper limb rehabilitation post stroke.
Intervention Type
Other
Intervention Name(s)
Mirror Box therapy
Intervention Description
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 Outcome Measure Information:
Title
Change in brain connectivity will be assessed by resting-state fMRI
Time Frame
Baseline, 3 weeks and at 6 weeks
Secondary Outcome Measure Information:
Title
Activity of daily living will be assessed with Barthel index.
Time Frame
Baseline, 3 weeks and at 6 weeks
Title
Function of the affected hemiplegic upper limb will be assessed with action research arm test
Time Frame
Baseline, 3 weeks and at 6 weeks
Title
Impairment in the hemiplegic upper limb will be assessed with Fugl Meyer test.
Time Frame
Baseline, 3 weeks and at 6 weeks
Title
Grip strength will be assessed using hand dynamometer
Time Frame
Baseline, 3 weeks and at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Grunwald
Organizational Affiliation
Anglia Ruskin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southend Hospital
City
Westcliff on Sea
State/Province
Essex
ZIP/Postal Code
SS0 0RY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mirror Box Imaging Study

We'll reach out to this number within 24 hrs