Mirror Box Imaging Study
|ClinicalTrials.gov Identifier: NCT02776306|
Recruitment Status : Unknown
Verified December 2016 by Southend University Hospital Foundation NHS Trust.
Recruitment status was: Recruiting
First Posted : May 18, 2016
Last Update Posted : December 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Mirror Box therapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effects of Mirror Box Therapy on Neuroplasticity and Functional Outcome in Hemiparetic Upper Limb Post Stroke|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: 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.
Other: 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.
No Intervention: Standard treatment group
The participants will receive the standard treatment arm for 3 weeks for upper limb rehabilitation post stroke.
- Change in brain connectivity will be assessed by resting-state fMRI [ Time Frame: Baseline, 3 weeks and at 6 weeks ]
- Activity of daily living will be assessed with Barthel index. [ Time Frame: Baseline, 3 weeks and at 6 weeks ]
- Function of the affected hemiplegic upper limb will be assessed with action research arm test [ Time Frame: Baseline, 3 weeks and at 6 weeks ]
- Impairment in the hemiplegic upper limb will be assessed with Fugl Meyer test. [ Time Frame: Baseline, 3 weeks and at 6 weeks ]
- Grip strength will be assessed using hand dynamometer [ Time Frame: Baseline, 3 weeks and at 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776306
|Contact: Susan Bowman||01702 firstname.lastname@example.org|
|Contact: Craig Mackerness||01702 email@example.com|
|Southend University Hospital NHS FoundationTrust||Recruiting|
|Westcliff on Sea, Essex, United Kingdom, SS0 0RY|
|Contact: Aarti Sharma 01702 435555 ext 6143 firstname.lastname@example.org|
|Principal Investigator:||Iris Grunwald||Anglia Ruskin University|