The goal of this clinical trial is to test a new treatment for adults with walking problems due to Functional Neurological Disorder (FND).
The main question the trial aims to answer is:
\- Is stimulation-enhanced physical therapy an effective treatment for walking problems due to FND?
Researchers will compare the stimulation-enhanced physical therapy to gold-standard physical therapy.
Participants will:
* Complete three in-person sessions on three consecutive days * Complete follow-up assessments by video call at 7 days, 30 days and 90 days after treatment
Clinically established diagnosis of FND or an equivalent term
Investigations are accepted as complete by the patient and treating physician
Walking difficulty that prevents crossing the road unaided at a traffic light pedestrian crossing
Lower limb functional weakness
Age < 21 years
Living with a parent or guardian who provides primary emotional support and assistance with most daily tasks
Medical instability precluding safe participation in physical therapy
Cognitive or communication impairment precluding informed consent or the ability to effectively engage in education aspects of the trial with family support
Parallel
Stimulation-Enhanced Physical Therapy
Combination productThe intervention uses Transcranial Magnetic Stimulation (TMS) to activate the motor pathways from the primary motor cortex to affected lower limb muscles. This is followed by specialist physical therapy applying consensus recommendations for the treatment of movement symptoms due to FND. Key elements include distraction, momentum, and exploratory movement.
Active Comparator
Other interventionThe active comparator uses structured goal-setting and movement imagery to prepare for physical therapy. This is followed by specialist physical therapy applying consensus recommendations for the treatment of movement symptoms due to FND. Key elements include distraction, momentum, and progressive movement retraining.
Odds of achieving effective treatment defined as a Tinetti Performance-Oriented Mobility Assessment (POMA) score of at least 24 out of 28.
The Tinetti POMA is a reliable and valid assessment for use with a broad range of neurological conditions, with excellent interrater reliability. It evaluates key symptom domains of gait, trunk stability, and postural balance. The minimum and worst score is zero. The maximum and best score is 28. The odds ratio for achieving effective treatment will be calculated for the treatment group relative to the control group.
Functional Movement Disorder Questionnaire (FMDQ)
The FMDQ is a summed severity and impact questionnaire in which participants rate the presence and severity of functional movement symptoms across multiple domains. Each item is scored on a Likert type scale, and a total score (range 31-181) is calculated, with higher scores indicating greater functional symptom burden.
EQ-5D-5L
The EQ-5D-5L is a self-reported questionnaire of quality of life that is validated for general and neurological populations. The EQ-5D-5L assesses five key dimensions of health and using a 5-point Likert scale. An index score is derived from the combination of individual domain ratings using a country-specific value set which reflects societal preferences for different health states.
Tinetti POMA score during follow-up
The Tinetti POMA score will be obtained via video call during the follow-up period. It evaluates key symptom domains of gait, trunk stability, and postural balance. The minimum and worst score is zero. The maximum and best score is 28.
Walking independence
Walking independence will be evaluated with the Functional Ambulation Category (FAC), which is a valid and reliable measure of a person's level of independence in mobility and walking. The lowest and worst score is zero, meaning fully dependent. The highest and best score is 5, meaning fully independent walking. Participants will be classified as independent if they have a FAC score of 4 or 5 out of 5. Participants will be classified as dependent if they have a FAC score of 0, 1, 2 or 3.
Simplified Functional Movement Disorders Rating Scale (S-FMDRS)
The S-FMDRS is a clinician-rated score of overall functional movement symptom severity. The assessor will video the assessment to support their review and scoring accuracy. A total score out of 54 is recorded with higher scores indicating greater symptom severity.
Lower limb strength
Total lower limb strength score will be calculated by summing the Medical Research Council grades for knee flexion, knee extension, ankle dorsiflexion, and ankle plantarflexion for each limb. The summed bilateral score will be used for analysis of between-group effects. The minimum and worst score is zero, the maximum and best score is 40.
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