Digital Telerehabilitation in Functional Motor Disorders

Functional Movement Disorder Clinical Trial

Official title:

Implementing a Digital Telerehabilitation Protocol and Non-motor Outcomes, and Quality of Life in Patients With Functional Motor Disorders: a Feasibility 2-arm Parallel Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06274281
• Other study ID #: TOMs_FMD
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: February 2024
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Functional motor disorders (FMDs) are a broad spectrum of functional neurological disorders, including abnormal gait/balance disorders. Patients experience high degrees of disability and distress, equivalent to those suffering from degenerative neurological diseases. Rehabilitation is essential in their management. 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 and experts in the field. The rehabilitation setting is not adequate for the long-term management and monitoring of these patients. Digital medicine is a new field that means "using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized." It can upgrade rehabilitation practice, addressing the existing critical components towards marked efficiency and productivity. Digital telerehabilitation will increase the accessibility to personalized rehabilitation by expert professionals placing tools to monitor the patient's health by themselves.

The increasing development and availability of portable and wearable technologies are rapidly expanding the field of technology-based objective measures (TOMs) in neurological disorders. However, substantial challenges remain in (1) recognizing TOMs relevant to patients and clinicians to provide accurate, objective, and real-time assessment of gait and activity in a real-world setting and (2) their integration into telerehabilitation systems towards a digital rehabilitation transition.

This feasibility study provides preliminary data on the integration of a real-time gait and activity analysis by wearable devices in the real world with a digital platform to improve the diagnosis, monitoring, and rehabilitation of patients with FMDs.

Description:

Functional movement disorders (FMDs) are part of a wide spectrum of functional neurological disorders characterized by abnormal movements (gait, dystonia, and tremor), which are clinical incongruent with movement disorders caused by neurological disease and are significantly altered by distraction or nonphysiologically manoeuvres. FMDs have an incidence ranging from 4 to 12 per 100.000 population per year and high prevalence (15-20%) in patients accessing neurological clinics. They are a high disabling condition 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 disease, such as Parkinson's Disease. Despite this, FMDs have been widely misunderstood, receiving little public and academic attention.

Diagnostic clinical criteria for FMDs are based on positive signs that support certain integrity of the pathway from an anatomical and physiological perspective: specific maneuvers can make apparent the function that seems to be lost or impaired. Despite the clinical burden, the exact pathophysiological mechanisms underlying FMDs have not been elucidated and so FMDs' management remain largely unknown. The hallmarks of FMDs patients distinguishing them from those with organic movement disorders is that their movements have features usually associated with voluntary movement. Still, patients report them as involuntary and not under their control. Why movements that appear voluntary because altered by distraction are experienced as involuntary (or outside the patient's control) is a matter of debate.

In addition to motor complaints, non-motor symptoms (NMSs) such as fatigue, pain, anxiety, depression have been increasingly recognized as important contributors producing levels of disability over and above those caused by the abnormal movement. Within this perspective should be considered the rehabilitation of patients with FMDs, to reduce disability and improve Health-related Quality of Life (QoL) in the context of a multidisciplinary team. To do that, there are limits that must be overcome: rehabilitation approaches are few and limited because of empirical approaches mainly referring to clinical practice without following evidence-based consensus recommendations, most existing studies are uncontrolled case series or crossover studies and innovations to improve access to specialist rehabilitation treatment by qualified professionals (i.e., tele/remote health an wearable technology) and to monitor patients in the long-term have been seldom explored in patients with FMDs.

Digital medicine, a new field based on "using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized", led the introduction of 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, enabling site-less, digital clinical trials where suitable participants are identified, consented, and enrolled remotely. The next phase of this will greatly impact clinicians across disciplines including rehabilitation. In fact, in the last few years, telerehabilitation (a telemedicine subfield consisting of a system to control rehabilitation at a distance) has been progressively developed allowing to overcome the barrier of distance and time (mainly in communities far from urban centers), to cut down the cost and labor of accessing healthcare, and to provide access to patients having temporary and permanent disabilities for accurate diagnosis and rehabilitation prescription and delivery.

Digital telerehabilitation combined the advantages of telerehabilitation with the possibility to use digital tools (i.e., wearable sensors, digital platform) in monitoring functions and activities in real-time and in the real-world environment. Digital Telemedicine platforms offer new opportunities for diagnosis, monitoring, treatment, and management of diseases allowing the acquisition, transmission, and storage of clinical information through electronic devices and communication technologies to provide and support remote health care, including rehabilitation. The use of digital technologies applied to rehabilitation through telemedicine systems (telerehabilitation) represents one of the main fronts of development in neurological rehabilitation as it offers the potential to extend specific rehabilitation paths from the hospital phase to the home phase allowing, thanks to the involvement of highly qualified personnel, better management of diseases and their clinical, social and economic outcomes.

The increasing development and availability of portable and wearable technologies are rapidly expanding the field of technology-based objective measures (TOMs) in neurological disorders. However, substantial challenges remain in (1) recognizing TOMs relevant to patients and clinicians to provide accurate, objective, and real-time assessment of gait and activity in a real-world setting and (2) their integration into telerehabilitation systems towards a digital rehabilitation transition. It is crucial in FMDs because of the clinical complexity of patients who require highly qualified personnel, adapting rehabilitation programs over time according to the patients' improvements, and long-term monitoring without impacting health care costs. Besides the pandemic caused by the SARS-CoV-2 virus, which has prevented patients from accessing rehabilitation in hospital settings, the restricted presence of qualified centers for the rehabilitation of patients with FMDs emphasizes the need to create specific digital telerehabilitation pathways by qualified staff that can reach patients who would not have access to such rehabilitative treatment. However, pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention (also commonly known as "feasibility" studies), must be designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicenter trials; to increase clinical experience with the study medication or intervention for the phase III trials . They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite.

The primary aim of the study is to implement and assess the feasibility of the steps that need to take place as part of the main confirmatory study on comparing the effects of a digital telerehabilitation program including TOMs on motor symptoms severity and duration in patients with FMDs. The secondary aim is then 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: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• 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

• acceptance of the diagnosis on the balance of probability

• severity and duration of motor impairment =1 scored with the Simplified Functional Movement Disorders Rating Scale (SFMDRS)

• acceptable level of digital skills.

Exclusion Criteria:

• Prominent dissociative seizures

• Mini-Mental State Examination <23/30

• Patients who continue to express some doubt over the diagnosis.

• prominent cognitive and physical impairment that preclude signing the informed consent for participation in the study.

• Unable or refuse to attend the consecutive 5-day rehabilitation treatment. Patients will give their written informed consent after being informed about the experimental nature of the study. According to the Helsinki Declaration, the study will be carried out, approved by the Local Ethics Committee, and registered at the clinical trial.

• Particularly vulnerable population. The following cannot be included in the study:

pregnant women, patients in an emergency.

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Movement Disorder
• Motor Disorders
• Movement Disorders

Intervention

Device:
• Digital Telerehabilitation
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. Wearable devices: each patient in the experimental group will receive 2 wearable sensors (Axivity AX3,) for monitoring of movement data (i.e., activity level, number of steps, distance travelled) during daylife activities and rehabilitation sessions. The subjective assessment of the patient's motor activity will be collected by clinical diaries focusing on gait and activity level.

Other:
• 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	Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona	Verona
Italy	USD Parkinson's Disease and Movement Disorders Unit	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients who accept/refuse the treatment, physiotherapy compliance and falls or event near falling occurred during rehabilitation	recruitment rate, acceptability of the intervention in terms of number of dropouts before the end of treatment, and safety in terms of reported adverse events during the treatment.	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	Budget issues related to TOMs	Budget issues in the use of TOMs during the EG intervention	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	Time spent to train patients	Time to train the patient in using the TOMs	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 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	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	The EuroQol-5D (EQ-5D)	It evaluates generic quality of life. The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').	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	iMTA Productivity Cost Questionnaire	It is a Standardized Instrument for Measuring and Valuing Health-Related Productivity Losses. Index score can vary from 0 to 21, with higher scores indicating better quality of life.	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	Gait outcome: Gait speed	They will be evaluated at hospital with Axivity AX3. The outcome for gait will be gait speed (cm/s)	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	Gait outcome: Stride length	They will be evaluated at hospital with Axivity AX3. The outcome for gait will be stride length (cm).	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	Gait outcome: Cadence	They will be evaluated at hospital with Axivity AX3. The outcome for gait will be cadence (step/min)	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	Balance outcome: CoP trajectory	They will be evaluated at hospital stabilometric platform. The outcome for postural control will be the length of the centre of pressure (CoP) trajectory (mm) measured in the eyes open (integrating visual, proprioceptive, and vestibular contributions) and the eyes closed condition (proprioceptive contribution to and the visual dependency on postural control).	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	Balance outcomes: Sway area	They will be evaluated at hospital stabilometric platform. The outcome for postural control will be the sway area (mm2) measured in the eyes open (integrating visual, proprioceptive, and vestibular contributions) and the eyes closed condition (proprioceptive contribution to and the visual dependency on postural control).	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)