Functional Neurological DisorderinteroPTfmdNCT06792760
Additive Effects of Interoceptive Training to Physiotherapy in Functional Movement Disorders (interoPTfmd)
A study testing Physiotherapy and Specific Breathing Techniques in people with Functional Neurological Disorder and Functional Movement Disorder, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Neurological Disorder, Functional Movement Disorder
- What is being tested?
- Physiotherapy and Specific Breathing Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- clinically established diagnosis of Functional Movement Disorder according to Gupta and Lang criteria
Who cannot join
- age <18 years
- inability to complete questionnaires because of language difficulties
- severe learning disabilities or cognitive impairment
- major psychiatric or organic neurological comorbidity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
General University Hospital in Prague
Prague, Czech Republic, 12800
About this study
Official title: Interoception in Functional Movement Disorders: Clinical and Neurophysiological Predictors of the Effect of Physiotherapy
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.
Read the detailed description
Functional Neurological Disorder (FND) is a poorly understood and prevalent disorder, making up 16% of outpatient neurology referrals. Patients with functional movement disorder (FMD), which is one of the most common subtypes of FND, are difficult to treat. While growing evidence highlights the effectiveness of physiotherapy for FMD, the absence of reliable predictors for treatment outcomes remains a major challenge in managing the condition effectively.
Our goal is to evaluate the interoceptive profile of individuals with FMD and establish a connection between interoceptive and attentional abnormalities, the type and severity of symptoms, and the response to treatment. The study will utilize the objective clinical and subjective evaluation of symptom severity along with behavioural, neurophysiological, and neuroimaging methods to provide a comprehensive set of measures of interoception and attention. fMRI will further elucidate the neural correlates of interoception and attention. These measures will be analyzed in a cohort of FMD patients and healthy controls to examine the relationship between interoception, attention, and the type, severity, and impact of motor and non-motor symptoms on quality of life.
Interoceptive and attentional measures will also be tested as markers of therapy outcomes in a prospective randomized controlled trial. Eighty FMD patients will be recruited to undergo FMD-specific physiotherapy, with one group receiving additional interoception training via a specific breathing technique (SBTs) protocol. Participants will be randomized to physiotherapy alone or physiotherapy plus SBTs, with clinical outcomes, interoceptive, and attentional measures assessed before and after treatment. This design will evaluate the interventions' impact and identify treatment outcome predictors.
Specific Aims Aim 1: To explore interoceptive mechanisms in FMD and their relationship to symptoms and treatment response.
1.1 Characterize interoceptive profiles (respiroceptive and cardioceptive sensitivity and metacognition) in FMD compared to healthy controls.
1.2 Investigate associations between interoception, motor symptoms, and pain. 1.3 Evaluate interoceptive sensitivity as a predictor of PT outcomes and the impact of SBTs on interoception and pain reduction.
1.4 Examine changes in interoceptive network activation (e.g., salience network) following PT, with or without SBTs.
Aim 2: To study attentional mechanisms in FMD and identify predictors of PT outcomes.
2.1 Assess distractibility as a predictor of PT outcomes. 2.2 Evaluate attentional measures during cognitive, emotional and oculomotor tasks and their relationship to FMD symptoms and PT outcomes.
2.3 Investigate changes in brain activation related to attentional processing and symptom control.
Aim 3: To evaluate the additive effects of specific breathing techniques (SBTs) on physiotherapy outcomes in FMD.
3.1 Compare outcomes between patients receiving PT alone and PT plus SBTs. 3.2 Assess whether SBTs enhance interoception and improve symptoms and HRQoL.
Methods:
Aim 1. Interoceptive sensitivity, metacognition, and attention will be evaluated using psychophysical tasks, fMRI, and eye-tracking to explore their relationship with symptoms and treatment outcomes in FMD.
Aim 2: Attentional mechanisms, including distractibility, will be assessed through clinical tasks, neurophysiological recordings, and fMRI to identify predictors of physiotherapy outcomes.
Aim 3: The effects of SBTs as an adjunct to physiotherapy will be evaluated using clinical scales for motor and non-motor symptoms, alongside quality-of-life and psychological measures.
- Being tested
- Physiotherapy, Specific Breathing Techniques
- Keywords
- Functional Movement Disorder, Interoception, Physiotherapy, Breathing techniques, Interoceptive training, Attention
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
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.
Specific Breathing TechniquesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FMD specific physiotherapy | Active comparator | This arm will receive specific physiotherapy treatment for people with Functional Movement Disorder based on published recommendations. Receives: 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 Receives: Other: Physiotherapy; Other: Specific Breathing Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Adapted Patient Clinical Global Impression Improvement (CGI-I) scale rated by the outcome assessor is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: one week after the last intervention, 6-month follow-up, 12-month follow-up
36-item Short Form Survey (SF-36)
The 36-item Short Form Health Survey (SF-36) is a self-report test assessing functional ability. Scores range from 0 to 100, with higher scores indicating better outcomes.
Measured: pre-treatment (baseline), one week after the last intervention, 6-month follow-up, 12-month follow-up
Fibromyalgia Survey Questionnaire
The Widespread Pain Index (WPI) and Somatic Symptom (SS) score are evaluated using the Fibromyalgia Survey Questionnaire. The WPI score ranges from 0 to 19 and assesses the distribution of pain across the body, while SS scores evaluate the intensity of associated symptoms. Higher scores indicate a worse outcome.
Measured: 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)
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS), a clinician-rated scale, assesses the severity of motor disorder symptoms across seven body regions. Scores range from 0 to 54, with higher scores indicating greater severity.
Measured: pre-treatment (baseline), one week after the last intervention, 6-month follow-up, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological DisorderStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, prospective, single-blind, interventional parallel arm clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Tereza Serranová, MD, PhD, Study director, General University Hospital in Prague, Neurology department, Prague, Czech Republic, 12800
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792760
- Sponsor's protocol ID
- NW24-04-00456
- Other IDs
- 53/23 Grant AZV VES 2024 VFN
- Acronym
- interoPTfmd
- Status last verified
- Jul 2025
- First submitted
- 20 Jan 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interoception in Functional Movement Disorders: Clinical and Neurophysiological Predictors of the Effect of Physiotherapy
- ClinicalTrials.gov ID
- NCT06792760
- Acronym / sponsor ID
- interoPTfmd / NW24-04-00456
- Keywords
- Functional Movement Disorder, Interoception, Physiotherapy, Breathing techniques, Interoceptive training, Attention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- General University Hospital, Prague
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Functional Neurological Disorder (FND) is a poorly understood and prevalent disorder, making up 16% of outpatient neurology referrals. Patients with functional movement disorder (FMD), which is one of the most common subtypes of FND, are difficult to treat. While growing evidence highlights the effectiveness of physiotherapy for FMD, the absence of reliable predictors for treatment outcomes remains a major challenge in managing the condition effectively.
Our goal is to evaluate the interoceptive profile of individuals with FMD and establish a connection between interoceptive and attentional abnormalities, the type and severity of symptoms, and the response to treatment. The study will utilize the objective clinical and subjective evaluation of symptom severity along with behavioural, neurophysiological, and neuroimaging methods to provide a comprehensive set of measures of interoception and attention. fMRI will further elucidate the neural correlates of interoception and attention. These measures will be analyzed in a cohort of FMD patients and healthy controls to examine the relationship between interoception, attention, and the type, severity, and impact of motor and non-motor symptoms on quality of life.
Interoceptive and attentional measures will also be tested as markers of therapy outcomes in a prospective randomized controlled trial. Eighty FMD patients will be recruited to undergo FMD-specific physiotherapy, with one group receiving additional interoception training via a specific breathing technique (SBTs) protocol. Participants will be randomized to physiotherapy alone or physiotherapy plus SBTs, with clinical outcomes, interoceptive, and attentional measures assessed before and after treatment. This design will evaluate the interventions' impact and identify treatment outcome predictors.
Specific Aims Aim 1: To explore interoceptive mechanisms in FMD and their relationship to symptoms and treatment response.
1.1 Characterize interoceptive profiles (respiroceptive and cardioceptive sensitivity and metacognition) in FMD compared to healthy controls.
1.2 Investigate associations between interoception, motor symptoms, and pain. 1.3 Evaluate interoceptive sensitivity as a predictor of PT outcomes and the impact of SBTs on interoception and pain reduction.
1.4 Examine changes in interoceptive network activation (e.g., salience network) following PT, with or without SBTs.
Aim 2: To study attentional mechanisms in FMD and identify predictors of PT outcomes.
2.1 Assess distractibility as a predictor of PT outcomes. 2.2 Evaluate attentional measures during cognitive, emotional and oculomotor tasks and their relationship to FMD symptoms and PT outcomes.
2.3 Investigate changes in brain activation related to attentional processing and symptom control.
Aim 3: To evaluate the additive effects of specific breathing techniques (SBTs) on physiotherapy outcomes in FMD.
3.1 Compare outcomes between patients receiving PT alone and PT plus SBTs. 3.2 Assess whether SBTs enhance interoception and improve symptoms and HRQoL.
Methods:
Aim 1. Interoceptive sensitivity, metacognition, and attention will be evaluated using psychophysical tasks, fMRI, and eye-tracking to explore their relationship with symptoms and treatment outcomes in FMD.
Aim 2: Attentional mechanisms, including distractibility, will be assessed through clinical tasks, neurophysiological recordings, and fMRI to identify predictors of physiotherapy outcomes.
Aim 3: The effects of SBTs as an adjunct to physiotherapy will be evaluated using clinical scales for motor and non-motor symptoms, alongside quality-of-life and psychological measures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, prospective, single-blind, interventional parallel arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| FMD specific physiotherapy | Active comparator | Other: PhysiotherapyThis arm will receive specific physiotherapy treatment for people with Functional Movement Disorder based on published recommendations. |
| FMD specific physiotherapy + specific breathing techniques | Experimental | Other: Physiotherapy, Other: Specific Breathing TechniquesThis arm will receive specific physiotherapy treatment for people with Functional Movement Disorder based on published recommendations + specific breathing exercises as interoceptive training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- clinically established diagnosis of Functional Movement Disorder according to Gupta and Lang criteria
Key exclusion criteria (4 listed)
- age <18 years
- inability to complete questionnaires because of language difficulties
- severe learning disabilities or cognitive impairment
- major psychiatric or organic neurological comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyThe 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. | Other | FMD specific physiotherapy, FMD specific physiotherapy + specific breathing techniques |
| Specific Breathing TechniquesThe 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. | Other | FMD specific physiotherapy + specific breathing techniques |
Primary outcome
Clinical Global Impressions (CGI) scale - patient rated
Time frame: pre-treatment (baseline), one week after the last intervention, 6-month follow-up, 12-month follow-up
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.
4 secondary outcomes
Clinical Global Impressions (CGI) - clinician rated scale
Time frame: one week after the last intervention, 6-month follow-up, 12-month follow-up
36-item Short Form Survey (SF-36)
Time frame: pre-treatment (baseline), one week after the last intervention, 6-month follow-up, 12-month follow-up
Fibromyalgia Survey Questionnaire
Time frame: 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)
Time frame: pre-treatment (baseline), one week after the last intervention, 6-month follow-up, 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tereza Serranová, MD, PhD study director
General University Hospital in Prague, Neurology department, Prague, Czech Republic, 12800
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy and Specific Breathing Techniques in people with Functional Neurological Disorder and Functional Movement Disorder, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impressions (CGI) scale - patient rated (time frame: pre-treatment (baseline), one week after the last intervention, 6-month follow-up, 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.