MIMIC: Mirror Box Therapy as a Treatment Option for Functional Movement Disorders

Sponsor

The Cleveland Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03660098

Collaborator

(none)

Enrollment

Location

60.1

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the potential of using mirror box therapy as a therapeutic technique amongst patients with functional movement disorders. It is hypothesized that a brief, single, in-office mirror therapy session will lead to a noticeable decrease in FMD-related involuntary movements.

Condition or Disease	Intervention/Treatment	Phase
Functional Movement Disorder

Detailed Description

Patients diagnosed with Functional Movement Disorder presenting with a unilateral or asymmetrical bilateral hand tremor will be asked to participate in a series of hand exercises with and without a mirror box. The severity of the tremor will be rated subjectively by the subject and objectively by the neurologist after hand exercises with and without the mirror box.

Study Design

Study Type:

Observational

Actual Enrollment :

14 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Mirror Box Therapy as a Treatment Option for Functional Movement Disorders

Actual Study Start Date :

Jun 28, 2018

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Outcome Measures

Primary Outcome Measures

Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score post exercise [Because this is a one-time visit study, outcome will be measured during the visit, data reported at study conclusion after successfully recruiting 14 subjects and completing analysis with projected finish date in 1 year]
The difference in scored movement severity in the more affected hand based on the modified s-FMDRS scale during the Unified Parkinson's Disease Rating Scale (UPDRS) exam after the exercises with vs. without the mirror box. Movements are scored by video raters on a scale of 0-3, and higher score indicates more severe movement.

Secondary Outcome Measures

Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score during exercise [Because this is a one-time visit study, outcome will be measured during the visit, data reported at study conclusion after successfully recruiting 14 subjects and completing analysis with projected finish date in 1 year]
The difference in scored movement severity in the more affected hand based on the modified s-FMDRS scale with vs. without the mirror box during exercise. Movements are scored by video raters on a scale of 0-3, and a higher score indicates more severe movement.
Change in self-perception [Because this is a one-time visit study, outcome will be measured during the visit, data reported at study conclusion after successfully recruiting 14 subjects and completing analysis with projected finish date in 1 year]
The difference in patient self-perception of movement severity based on a self-perception scale after the task with vs. without the mirror box. Patient scores movement on a scale of 0-4, with a higher score indicating more severe movement.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with functional movement disorder by a fellowship trained movement disorders neurologist, presenting predominantly with unilateral or asymmetrical bilateral involuntary movement in the upper extremity
In patients with bilateral involuntary movements, the symptoms in one arm must be minimal

Exclusion Criteria:

Patients with moderate to severe involuntary movement in both arms
Significant cognitive impairment that prevents proper informed consent
Severe involuntary movement that interferes with the use of the apparatus
Patients with hemiparesis or the loss of one arm due to various reasons (e.g. amputations, birth defects, etc.