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OpenTrials
Completed

NCT Number: NCT03660098

Mirror Box Therapy As a Treatment Option for Functional Movement Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score post exercise

    Time frame: 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 outcomes

  1. Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score during exercise

    Time frame: 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.

  2. Change in self-perception

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: MIMIC

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 6, 2018
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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