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Clinical Trial Details — Status: Active, not recruiting

Administrative data

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

Study information

Verified date July 2023
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

Outcome

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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