Functional Movement Disorder Clinical Trial
— MIMICOfficial title:
Mirror Box Therapy as a Treatment Option for Functional Movement Disorders
NCT number | NCT03660098 |
Other study ID # | 18-458 |
Secondary ID | |
Status | Active, not recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 28, 2018 |
Est. completion date | July 2024 |
Verified date | July 2023 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 14 |
Est. completion date | July 2024 |
Est. primary completion date | May 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Arya KN, Pandian S. Effect of task-based mirror therapy on motor recovery of the upper extremity in chronic stroke patients: a pilot study. Top Stroke Rehabil. 2013 May-Jun;20(3):210-7. doi: 10.1310/tsr2003-210. — View Citation
Chan BL, Witt R, Charrow AP, Magee A, Howard R, Pasquina PF, Heilman KM, Tsao JW. Mirror therapy for phantom limb pain. N Engl J Med. 2007 Nov 22;357(21):2206-7. doi: 10.1056/NEJMc071927. No abstract available. — View Citation
Chatterjee P, Banerjee R, Choudhury S, Mondal B, Kulsum MU, Chatterjee K, Kumar H. Mirror movements in Parkinson's disease: An under-appreciated clinical sign. J Neurol Sci. 2016 Jul 15;366:171-176. doi: 10.1016/j.jns.2016.05.026. Epub 2016 May 14. — View Citation
Diers M, Christmann C, Koeppe C, Ruf M, Flor H. Mirrored, imagined and executed movements differentially activate sensorimotor cortex in amputees with and without phantom limb pain. Pain. 2010 May;149(2):296-304. doi: 10.1016/j.pain.2010.02.020. Epub 2010 Mar 31. — View Citation
Jacob AE, Kaelin DL, Roach AR, Ziegler CH, LaFaver K. Motor Retraining (MoRe) for Functional Movement Disorders: Outcomes From a 1-Week Multidisciplinary Rehabilitation Program. PM R. 2018 Nov;10(11):1164-1172. doi: 10.1016/j.pmrj.2018.05.011. Epub 2018 May 18. — View Citation
Jose N. Mirror Box Therapy. Int. J. Adv. Nur. Management. 2014 Apr;2(2):97-9.
Morgante F, Edwards MJ, Espay AJ. Psychogenic movement disorders. Continuum (Minneap Minn). 2013 Oct;19(5 Movement Disorders):1383-96. doi: 10.1212/01.CON.0000436160.41071.79. — View Citation
Moseley LG, Gallace A, Spence C. Is mirror therapy all it is cracked up to be? Current evidence and future directions. Pain. 2008 Aug 15;138(1):7-10. doi: 10.1016/j.pain.2008.06.026. Epub 2008 Jul 14. No abstract available. — View Citation
Ricciardi L, Edwards MJ. Treatment of functional (psychogenic) movement disorders. Neurotherapeutics. 2014 Jan;11(1):201-7. doi: 10.1007/s13311-013-0246-x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score post exercise | 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. | 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 | |
Secondary | Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score during exercise | 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. | 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 | |
Secondary | Change in self-perception | 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. | 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 |
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