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Clinical Trials/NCT02776306
NCT02776306
Completed
N/A

Effects of Mirror Box Therapy on Neuroplasticity and Functional Outcome in Hemiparetic Upper Limb Post Stroke

Mid and South Essex NHS Foundation Trust1 site in 1 country40 target enrollmentApril 2016
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Mid and South Essex NHS Foundation Trust
Enrollment
40
Locations
1
Primary Endpoint
Change in brain connectivity will be assessed by resting-state fMRI
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
April 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: Baseline, 3 weeks and at 6 weeks

Secondary Outcomes

  • Activity of daily living will be assessed with Barthel index.(Baseline, 3 weeks and at 6 weeks)
  • Function of the affected hemiplegic upper limb will be assessed with action research arm test(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)

Study Sites (1)

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