Additive Effects of Interoceptive Training to Physiotherapy in Functional Movement Disorders (interoPTfmd)

NCT06792760 | Enrolling By Invitation

• 2 other identifiers: NW24-04-0045653/23 Grant AZV VES 2024 VFN
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Functional movement disorder (FMD) is a common source of neurological disability that imposes a significant financial burden on healthcare systems. However, the heterogeneous manifestations of FMD and numerous associated non-motor symptoms, often fluctuating over time, present a challenge for developing effective treatment pathways. Although increasing evidence supports the efficacy of physiotherapy for FMD, the lack of predictors of treatment outcomes remains a significant obstacle to effectively managing FMD. The main hypothesis of this project is that abnormalities in interoceptive processing are responsible for variability in motor and non-motor symptoms and response to physiotherapy. Interoception describes the afferent signalling, central processing, and mental representation of internal bodily signals. We hypothesize that worse performance on interoceptive tests will be associated with greater severity of motor and non-motor symptoms and worse quality of life. We also expect that patients with worse interoceptive performance and associated non-motor symptoms such as pain will particularly benefit from treatment techniques modulating interoception, such as specific breathing techniques. Therefore, to test our hypotheses, in this project, we will study interoceptive and attentional abnormalities of FMD and identify predictors of the effect of physiotherapy and interoceptive respiratory training.

Conditions

Functional Neurological Disorder; Functional Movement Disorder

Keywords

Functional Movement Disorder; Interoception; Physiotherapy; Breathing techniques; Interoceptive training; Attention

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impressions (CGI) scale - patient rated

  Clinical Global Impressions (CGI-I) scale, patient-rated, is a 5-point scale evaluating improvement from 'very much improved' to 'very much worse'. 'Very much improved' indicates a better outcome.

  pre-treatment (baseline), one week after the last intervention, 6-month follow-up, 12-month follow-up

Secondary Outcomes (4)

• Clinical Global Impressions (CGI) - clinician rated scale

  one week after the last intervention, 6-month follow-up, 12-month follow-up

• 36-item Short Form Survey (SF-36)

  pre-treatment (baseline), one week after the last intervention, 6-month follow-up, 12-month follow-up

• Fibromyalgia Survey Questionnaire

  pre-treatment (baseline), one week after the last intervention, 6-month follow-up, 12-month follow-up

• The Simplified Functional Movement Disorders Rating Scale (S-FMDRS)

  pre-treatment (baseline), one week after the last intervention, 6-month follow-up, 12-month follow-up

Other Outcomes (16)

• Work and Social Adjusment Scale (WSAS)

  pre-treatment (baseline), 6-month follow-up, 12-month follow-up

• Illness belief and understanding and confidence in the diagnosis

  pre-treatment (baseline)

• Readiness for treatment

  pre-treatment (baseline)

Study Arms (2)

FMD specific physiotherapy

ACTIVE COMPARATOR

This arm will receive specific physiotherapy treatment for people with Functional Movement Disorder based on published recommendations.

Other: Physiotherapy

FMD specific physiotherapy + specific breathing techniques

EXPERIMENTAL

This arm will receive specific physiotherapy treatment for people with Functional Movement Disorder based on published recommendations + specific breathing exercises as interoceptive training

Other: Physiotherapy; Other: Specific Breathing Techniques

Interventions

Physiotherapy OTHER

The intervention will consist of 10 individual physiotherapy sessions delivered by a single physiotherapist trained in FMD. The physiotherapy programme will include education, movement retraining and a self-management plan.

FMD specific physiotherapy; FMD specific physiotherapy + specific breathing techniques

Specific Breathing Techniques OTHER

The intervention will include education and training in specific breathing techniques, which will be exercised by the patient as a self-management plan for over 5-10 minutes daily.

FMD specific physiotherapy + specific breathing techniques

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• clinically established diagnosis of Functional Movement Disorder according to Gupta and Lang criteria

You may not qualify if:

• age \<18 years
• inability to complete questionnaires because of language difficulties
• severe learning disabilities or cognitive impairment
• major psychiatric or organic neurological comorbidity

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• General University Hospital, Prague: collaborator

Study Sites (1)

General University Hospital in Prague

Prague, Czech Republic, 12800, Czechia

Location

MeSH Terms

Conditions

Conversion Disorder

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Tereza Serranová, MD, PhD

  General University Hospital in Prague, Neurology department, Prague, Czech Republic, 12800

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, prospective, single-blind, interventional parallel arm clinical trial

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: "Beginning 1 year after publication with no end date"
• Access Criteria: Anonymized data will be shared with other researchers based on reasonable request.

Locations

CZ (1)