Telemedicine in Functional Motor Disorder

Functional Movement Disorder Clinical Trial

— TeleFMD  

Official title:

Effectiveness of Telemedicine on Health Outcomes (Clinical, Humanistic, Economic) in the Management of Patients With Functional Motor Disorder: Randomised Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345340
• Other study ID #: TeleFMD-BRFVr
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: March 2024

Study information

• Verified date: April 2022
• Source: Universita di Verona
• Contact: Michele Tinazzi, PhD
• Phone: +390458124285
• Email: michele.tinazzi[@]univr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Functional motor disorders (FMDs) are a broad spectrum of functional neurological disorders, referring to abnormal movements like dystonia, tremor, and gait/balance disorders. Patients with FMDs experience high degrees of disability and distress equivalent to those suffering from degenerative neurological diseases. Rehabilitation is essential in managing FMDs. However, the current systems of rehabilitation delivery face two main challenges. Patients are not receiving the amount and kind of evidence-based rehabilitation they need due to the lack of rehabilitation professionals' experts in the field. The rehabilitation setting is not adequate for the long-term management and monitoring of these patients. To date, no randomized controlled trials are evaluating the effectiveness of Telemedicine in the management of patients with FMD. This is a single-blind randomized-controlled trial (RCT) with 2-parallel arms to demonstrate the effectiveness and superiority of a 5-day intensive rehabilitation treatment followed by a telemedicine program on the motor, non-motor symptoms (pain, fatigue, anxiety, and depression), the self-perception of clinical change and Health-Related Quality of Life, and health care costs in patients with FMDs.

Description:

Functional movement disorders (FMDs) are part of a broad spectrum of functional neurological disorders characterized by abnormal movements (gait, dystonia, and tremor), which are clinically incongruent with movement disorders caused by neurological disease and are significantly altered distraction or nonphysiologically maneuvers. FMDs have an incidence ranging from 4 to 12 per 100.000 population per year and a high prevalence (15-20%) in patients accessing neurological clinics. They are high disabling conditions characterized by long-term disability, poor quality of life, and economic impact on health and social care systems. Indeed, these patients experience disability and distress equivalent to those suffering from degenerative neurological diseases, such as Parkinson's Disease. Despite this, FMDs have been widely misunderstood, receiving little public and academic attention. Motor deficits, gait and balance disorders, and sensory manifestations are the most frequent symptoms and the leading cause of disability in patients with FMDs. They may occur in an isolated or combined manner, increasing the clinical complexity of these patients. Motor FMDs include functional poverty of movements, weakness, and slowness. Pain and fatigue are invalidating non-motor symptoms (NMSs) associated with FMDs. The pathophysiology of FMDs and their management remain largely unknown. The old assumption of psychological factors as the primary cause (psychogenic illness) has been abandoned due to the lack of evidence about their causal role. They have been removed from the diagnostic criteria described in the DSM-V and are considered risk factors. Recent research findings suggest three key processes involved in the neurobiology of FMD: abnormal attentional focus, abnormal beliefs/expectations, and abnormalities in the sense of agency. Rehabilitation is essential in managing FMDs to improve function and quality of life in the context of a multidisciplinary team. Of note, patients with functional motor disorder may have much greater potential for recovery than health professionals often consider. However, three unmet needs remain crucial. Firstly, rehabilitation approaches are few and limited because empirical approaches mainly refer to clinical practice without following evidence-based consensus recommendations. Secondly, most existing studies are uncontrolled case series or crossover studies. Finally, adjuncts and innovations to improve access to specialist rehabilitation treatment by qualified professionals (i.e., tele/remote health and wearable technology) and monitor patients in the long-term have seldom been explored in patients with FMDs. The literature shows how these patients generally feel misunderstood and neglected by health professionals, becoming progressively more vulnerable. The connectivity of mobile devices with the internet ushered in technology platforms like telemedicine and wearable sensors, endowing hand-held devices with the ability to acquire and track data on physiologic systems (i.e., cardiovascular, gait) in the ecological setting at home and during the Activities of Daily Living. This introduced a new path for generating a new form of healthcare through the medical data acquisition by the individual, in real-time, in a real-world environment. Telemedicine overcomes the barrier of distance and time and provides access to patients having temporary and permanent disabilities for accurate diagnosis and rehabilitation prescription and delivery. To the best of our knowledge, no studies have been performed on the effectiveness of digital telerehabilitation on motor and non-motor outcomes and quality of life in patients with FMDs. A range of factors supports the implementation of digital telerehabilitation treatments in managing patients with FMDs. Aims of the project Primary aim: To compare the effects of a telemedicine program on motor symptoms severity and duration in patients with FMDs. Secondary aim: to compare the training effects on non-motor symptoms (pain, fatigue, anxiety, and depression), the self-perception of clinical change and Health-Related Quality of Life, and health care costs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: March 2024
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a clinically definite diagnosis of FMDs based on Gupta and Lang diagnostic criteria with the presence of distractibility maneuvers and a demonstration of positive signs;
• the presence of 1 (isolated FMDs) or more clinical motor symptoms (combined FMDs), including weakness, tremor, jerks, dystonia, gait disorders, and parkinsonism;
• acceptable level of digital skills.

Exclusion Criteria:

• prominent dissociative seizures
• prominent cognitive and physical impairment that precludes signing the informed consent for participation in the study;
• unable or refuse to attend the consecutive 5-day rehabilitation treatment

Related Conditions & MeSH terms

• Functional Movement Disorder
• Motor Disorders
• Movement Disorders

Intervention

Other:
• Telemedicine
The 5-day rehabilitation program will consist of exercises to re-establish standard movement patterns within a multidisciplinary etiological framework, according to a validated rehabilitation protocol for FMDs. Treatment will be tailored to the needs of each patient, following general treatment principles in physiotherapy for FMDs. Telemedicine sessions: the patient will perform specific exercises under the supervision of a qualified physiotherapist to provide feedback on the execution and adapt the treatment according to clinical changes/improvements. Polar Vantage M devices will collect the objective measurement after the 5-day rehabilitation program (for five consecutive days), week 12 (for five consecutive days), and week 24 (for five consecutive days).
• Usual care
The 5-day rehabilitation program will be the same as the telemedicine group. A self-management paper log will be given to the patient at the end of the 5-day rehabilitation program. It will include goals, activity plans, and strategies to be used for retraining movements and redirecting attention. Videos stored on the patients' digital device (i.e., tablet, mobile) will include exercises demonstration and execution and strategies to retrain movements. Patients will be encouraged to perform the self-management plan at home on their own (or with their caregivers' help) which will be reported in a paper log and video recorded. The subjective assessment of the patient's motor activity will be collected by clinical diaries focusing on gait and activity level.

Locations

Country	Name	City	State
Italy	USD Parkinson's Disease and Movement Disorders Unit	Verona

Sponsors (2)

Lead Sponsor	Collaborator
Universita di Verona	Marialuisa Gandolfi

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Espay AJ, Aybek S, Carson A, Edwards MJ, Goldstein LH, Hallett M, LaFaver K, LaFrance WC Jr, Lang AE, Nicholson T, Nielsen G, Reuber M, Voon V, Stone J, Morgante F. Current Concepts in Diagnosis and Treatment of Functional Neurological Disorders. JAMA Neurol. 2018 Sep 1;75(9):1132-1141. doi: 10.1001/jamaneurol.2018.1264. Review. — View Citation

Gandolfi M, Riello M, Bellamoli V, Bombieri F, Geroin C, Di Vico IA, Tinazzi M. Motor and non-motor outcomes after a rehabilitation program for patients with Functional Motor Disorders: A prospective, observational cohort study. NeuroRehabilitation. 2021;48(3):305-314. doi: 10.3233/NRE-201617. — View Citation

Gupta A, Lang AE. Psychogenic movement disorders. Curr Opin Neurol. 2009 Aug;22(4):430-6. doi: 10.1097/WCO.0b013e32832dc169. Review. — View Citation

Nielsen G, Stone J, Matthews A, Brown M, Sparkes C, Farmer R, Masterton L, Duncan L, Winters A, Daniell L, Lumsden C, Carson A, David AS, Edwards M. Physiotherapy for functional motor disorders: a consensus recommendation. J Neurol Neurosurg Psychiatry. 2015 Oct;86(10):1113-9. doi: 10.1136/jnnp-2014-309255. Epub 2014 Nov 28. — View Citation

Perez DL, Edwards MJ, Nielsen G, Kozlowska K, Hallett M, LaFrance WC Jr. Decade of progress in motor functional neurological disorder: continuing the momentum. J Neurol Neurosurg Psychiatry. 2021 Mar 15. pii: jnnp-2020-323953. doi: 10.1136/jnnp-2020-323953. [Epub ahead of print] Review. — View Citation

Tinazzi M, Morgante F, Marcuzzo E, Erro R, Barone P, Ceravolo R, Mazzucchi S, Pilotto A, Padovani A, Romito LM, Eleopra R, Zappia M, Nicoletti A, Dallocchio C, Arbasino C, Bono F, Pascarella A, Demartini B, Gambini O, Modugno N, Olivola E, Di Stefano V, Albanese A, Ferrazzano G, Tessitore A, Zibetti M, Calandra-Buonaura G, Petracca M, Esposito M, Pisani A, Manganotti P, Stocchi F, Coletti Moja M, Antonini A, Defazio G, Geroin C. Clinical Correlates of Functional Motor Disorders: An Italian Multicenter Study. Mov Disord Clin Pract. 2020 Sep 22;7(8):920-929. doi: 10.1002/mdc3.13077. eCollection 2020 Nov. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of drop-out	the number of dropouts before the end of treatment will be collected. The EG will report adverse events on the Digital Telemedicine platform, while the CG on the paper log.	before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Other	Number of falls or events near falling.	The number of falls or events near falling will be collected on the on the Digital Telemedicine platform, while the CG on the paper log.	before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Primary	Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score	Objective-rated validated scale to rate the duration and severity of functional motor symptoms (range: 0-54; higher = worse).	before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Secondary	Change in the Multidimensional Fatigue Inventory Scale (MFI-20) score	It evaluates fatigue differentiating general, physical, reduced-activity, reduced-motivation, and mental fatigue (subscale range: 4-20; higher = worse).	before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Secondary	Change in the Brief Pain Inventory (BPI) score	It evaluates pain intensity (range: 0-40; higher = worse) and interference (range: 0-70; higher = worse).	before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Secondary	Change in the Beck Depression Inventory (BDI-II) score	It evaluates depression (range: 0-63; higher = worse).	before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Secondary	Change in the Beck Anxiety Inventory (BAI) score	It evaluates anxiety (range: 0-63; higher = worse).	before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Secondary	Change in the 12-item Short-Form Health Survey (SF-12) score	The health-Related QoL will be evaluated by the Mental Health and Physical functioning of the 12-item Short-Form Health Survey (SF-12) (range: 0-100; higher = better)	before the intensive 5-day rehabilitation program (T0), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Secondary	Change in the Clinical Global Impression (CGI) score	Self-rated perception of change will be assessed with the 7-point Clinical Global Impression (CGI) scale with scores from 1 (very much improved) to 7 (very much worse).	the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Secondary	Change in the spatio-temporal gait parameters	Gait analysis will be used to collect gait speed (cm/s), cadence (step/min), and stride length (cm).	before the intensive 5-day rehabilitation program (T0), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Secondary	Change in the postural control assessment	An electronic monaxial stabilometric platform will be used to evaluate postural control.	before the intensive 5-day rehabilitation program (T0), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Secondary	Healthcare Services Volume ad-hoc questionnaire	The number of the health services consulted six months before the intensive 5-day rehabilitation program will be retrospectively collected through an ad-hoc questionnaire. The same information will be prospectively collected during the study period (6 months).	before the intensive 5-day rehabilitation program (T0), and at 24 weeks (follow-up, T3)
Secondary	Change in the Toronto Alexithymia Scale (TAS-20) score	It evaluates the level of alexithymia (range: 20-100; higher = worse),	before the intensive 5-day rehabilitation program (T0), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)
Secondary	Number of direct Healthcare Costs consumption by an ad-hoc questionnaire	The number of examinations, medications, medical visits, hospital admissions, and Emergency Room visits performed before the intensive 5-day rehabilitation will be retrospectively collected through an ad-hoc questionnaire. The same information will be prospectively collected during the study period (6 months).	before the intensive 5-day rehabilitation program (T0), and 24 weeks (follow-up, T3)
Secondary	Number of days off.	The number of days off for the patient.	before the intensive 5-day rehabilitation program (T0), after 12 weeks (at the end of the self-management plan, T2),and after 24 weeks (follow-up, T3)