Mirror Box Therapy As a Treatment Option for Functional Movement Disorders

Completed

• Conditions: Functional Movement Disorder

• Registration Number: NCT03660098
• Lead Sponsor: The Cleveland Clinic

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.

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 Timeline

• Study Start: 2018-06-28
• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-06
• Primary Completion: 2022-05-17
• Study Completion: 2022-05-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. 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
2. In patients with bilateral involuntary movements, the symptoms in one arm must be minimal

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States