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Table 1 Physio4FMD Intervention description following the TIDIER checklist

From: Physio4FMD: protocol for a multicentre randomised controlled trial of specialist physiotherapy for functional motor disorder

1. Name Provide the name or a phrase that describes the intervention.
Physio4FMD: Specialist physiotherapy for functional neurological disorder.
2. Why Describe the rationale, theory, or goal of the elements essential to the intervention.
The rationale for the Physio4FMD treatment is primarily based on a particular aetiological model for FMD [18]. The model highlights two key mechanisms that drive functional motor symptoms. These are:
1. Functional motor symptoms require the patient’s attention, at a level without voluntary control, to be directed towards their body in order to manifest. When the patient’s attention is distracted, the movement disorder disappears or dampens.
2. The patient has an expectation, at a level without voluntary control, that their movement will be abnormal; this expectation is associated with a particular illness belief (e.g. my legs are paralysed). Expectations of abnormal movement influence motor output with symptoms arising as a ‘habit’ that the nervous system has got in to.
The Physio4FMD intervention addresses attention-related movement problems by retraining activity (movement) while redirecting the patient’s focus of motor attention. Altered expectations and illness beliefs are addressed through education, demonstrating to the patient that they can move normally and helping the patient to develop strategies that normalises their movement during every day activities.
The essential elements of the intervention are:
1. Prior to physiotherapy, the participant receives a diagnosis of FMD by a neurologist. The neurologist gives a thorough explanation of FMD and how the diagnosis was made positively based on clinical features, and not as a diagnosis of exclusion.
2. Education about FMD, following which the participant and physiotherapist collaboratively devise a formulation to theorise how the patient developed their movement problem using the aetiological model as a framework [9].
3. Education about common problems associated with FMD (persistent pain, fatigue and memory/concentration problems).
4. Movement and posture retraining, with the participant’s focus of attention directed away from their body (areas addressed include sitting postures, sit to stand, walking, getting on and off the floor, stairs, upper limb problems, and use of walking aids).
5. Developing a self-management plan (which includes understanding medication, addressing boom-bust patterns of activity, how to incorporate movement strategies into daily routine, self-management goals, and managing symptom exacerbations and relapses).
3. What: Materials Describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers. Provide information on where the materials can be accessed (such as online appendix, URL).
Information for Neurologists, document: Each trial neurologist will receive a document summarising their role in the trial, which includes an explanation of how to apply the eligibility criteria, how to explain FMD to patients, how to discuss the trial with potential participants, and requirements for follow up.
Patient Workbook: Each intervention participant is given a workbook, which guides the intervention. The workbook is completed by both the participant and the physiotherapist during treatment. Key sections of the workbook are: (i) understanding the diagnosis; (ii) neuroanatomy and physiology; (iii) pages for participants to reflection on sessions; (iv) analysis and exploration of movement; (v) movement retraining; (vi) understanding problems associated with FMD (pain, fatigue and memory problems); and (vii) self-management plan. Amongst other goals, the workbook helps to standardise the intervention.
Physiotherapy Intervention Manual: Each physiotherapist providing the trial intervention will receive an intervention manual that complements the Physio4FMD training programme.
4. What: Procedures Describe each of the procedures, activities and/or processes used in the intervention, including any enabling or support activities.
Neurology: Prior to enrolling in the trial, participants in both groups are seen by one of the study neurologists. The diagnosis of FMD is made and explained to the patient following a standardized explanation [16]. Participants in both arms of the trial will be followed up by their neurologist at least once within 12 months of their initial neurology consultation.
Physiotherapy – Education: Participants receive a standardised explanation of FMD using the workbook as a guide. This is followed by an individualised formulation, where the participant and physiotherapist collaboratively devise a theoretical explanation for how the person came to develop FMD, using a symptom model [9]. The formulation seeks to determine relevant risk factors, triggers, initial symptoms, examples of attention affecting movement, adaptive coping strategies, secondary changes, and social factors. Education includes information about some common problems associated with FMD (pain, fatigue, and memory/concentration).
Physiotherapy – Movement Retraining: Movement retraining generally follows a sequential motor learning approach, building up desired movement patterns starting from elementary, symptom free components of movement [13]. Problematic movement patterns and tasks are identified in the initial assessment; only those relevant to individual are retrained. The workbook prompts exploration and practice of 7 key tasks (i) sitting postures, (ii) sit to stand, (iii) standing and walking, (iv) arm and hand problems, (v) use of walking aids, (vi) getting on and off the floor, and (vii) using stairs.
Movement retraining is tailored to the individual, but should adhere to the key principle of employing strategies that redirect the patient’s focus of motor attention. In practice this is achieved by:
• Asking the patient to focus on the goal of the task rather than the mechanics of movement
• Practice movements in front of a mirror (the patient focus of attention is redirected externally to their reflection)
• Redirecting the patient’s focus to an another part of their body or a specific component of the movement
Specific exercises and activities to retrain movement that conform to the above principles are suggested in the intervention manual and have been published elsewhere [13]. If available, the physiotherapist may choose to use the following standard physiotherapy adjuncts: electrical muscle stimulation, treadmill, other exercise equipment.
Physiotherapy – Personal Reflections: At the end of each physiotherapy session, the participant is encouraged to write a reflection in their workbook, addressing several prompts. The subsequent session starts by reviewing the reflection of the previous session and discussing any questions or issues that arise. After which, a plan is made for the current session.
Physiotherapy – Self-Management: To conclude treatment, a personalised self-management plan is developed, which usually includes: (i) a summary of useful strategies that help to normalise movement; (ii) activity plans to address boom and bust patterns and how to progress activity; (iii) future goals; and (iv) what to do on difficult days and during periods of symptom exacerbation.
5. Who provided For each category of intervention provider, describe their expertise, background and any specific training given.
Neurologists: All neurologists involved in the trial will be employed at a consultant level at one of the trial sites. Only neurologists with a clinical interest and experience in treating patients with FMD will be invited to participate. They will receive training from one of the research neurologists (ME or JS) in person or by telephone, lasting 30–60 min. The training topics are listed in item 3 above. This information will be supplemented with written information.
Physiotherapists: The intervention physiotherapists will have at least 2 years’ experience working in the field of neurological physiotherapy. Each will undergo 1 week full time training, delivered by the research physiotherapists (GN and KH). Competency will be assessed according to a checklist that ensures the physiotherapist has demonstrated an understanding or proficiency in delivering the key ingredients of the intervention. They will also receive a comprehensive intervention manual. During delivery of the intervention, each physiotherapist will receive supervision over telephone from one of the research physiotherapists. At least one supervision session will be planned for every intervention participant treated.
6. How Describe the modes of delivery (such as face to face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individual or in a group.
Each session is conducted face to face and individually (there are no group treatment sessions).
7. Where Describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features.
Participants will be recruited from inpatient or outpatient neurology clinics. The physiotherapy sessions will be held in a physiotherapy gym or clinic with space suitable for movement and gait retraining and space suitable for education and writing in the intervention workbook. The only essential equipment is a full-length mirror. Physiotherapists can make use of other standard therapeutic equipment as appropriate (e.g. treadmill, electrical muscle stimulation device, other exercise equipment).
8. When and how much Describe the number of times the intervention was delivered an over what period of time including the number of sessions, their schedule and their duration, intensity or dose.
The physiotherapy intervention is delivered over 9 sessions, which should be completed within a 3-week period. There is also a 3-month follow up session. Each session should last between 45 min and one hour. It is permissible to schedule 2 sessions in 1day, separated by a (lunch) break. Home exercise programmes are not usually part of the intervention. Instead, the patient is encouraged to incorporate movement strategies and plans (e.g. activity plan to avoid boom and bust patterns) into their normal daily routine.
9. Tailoring If the intervention was planned to be personalised, titrated or adapted, then describe what, why, when and how.
The intervention is standardised by following a workbook; however, only information and tasks relevant to the individual’s problem will be addressed. Movement retraining focuses on 7 key tasks, which are described in item 4 above. When retraining each task, strategies are adapted and personalised for the individual, but the approach should adhere to the key principle of redirecting the participant’s attention away from their movement or body. Passive interventions such as massage and acupuncture are discouraged.
10. Modifications If the intervention was modified during the course of the study, describe the changes (what, why, when, and how).
Not applicable.
11. How well: Planned If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them.
Fidelity of the intervention will be assessed in the following ways.
(i) At the level of the physiotherapist: The physiotherapist providing the trial intervention will complete a treatment checklist (paper form) for each participant, which conforms to the TIDIER intervention description.
(ii) At the level of the participant: We will monitor the content, length and number of physiotherapy sessions by participant report for both trial arms with a structured telephone survey. The interview will also assess for contamination between the groups.
(iii) Fidelity of the trial intervention will also be assessed by evaluating a random sample of completed intervention workbooks. The workbook guides the intervention and is filled in during the treatment session by both the participant and physiotherapist. It therefore provides a record of the content of sessions. Fidelity will be judged against predefined criteria. We aim to assess 40% of the intervention workbooks.
12. How well: Actual If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned.
Not applicable.