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临床试验/NCT07378488
NCT07378488进行中(未招募)不适用

Structured Dance/Movement Therapy for Functional Neurological Disorder: A Feasibility Study

King's College London1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Feasibility of the intervention: Recruitment

研究概览

简要总结

Building on evidence for somatic or physical interventions in functional neurological disorder (FND), the goal of this study is to test the feasibility of a structured dance/movement task in individuals with FND, and explore the potential use of somatic or body-based therapies in this population.

The primary study outcomes will be the feasibility and acceptability of a structured dance/movement therapy (DMT) intervention for individuals diagnosed with FND. The study will also explore whether this type of intervention has potential to contribute to elevating trust in the body and general wellbeing, alongside reducing functional neurological and dissociative symptoms.

Researchers will compare structured dance/movement therapy to a physical exercise/body coordination condition.

详细描述

Functional neurological disorder (FND) sits in between neurology and psychiatry, including symptoms like tremors, limb weakness, functional seizures, and sensory issues. Previous research has found elevated dissociative symptoms (i.e., feelings of detachment or disconnection from the self or surroundings) and/or dissociative disorder comorbidities (i.e., dissociative identity disorder, dissociative amnesia) in FND populations relative to the general population. There is also emerging evidence for alterations in aspects of bodily awareness in FND, specifically including a lack of trust in the body and an increased tendency or likelihood to distract from bodily sensations, and atypical autonomic reactivity. These alterations may contribute to, or play a role in the experience of, FND symptoms.

Dance/movement therapy (DMT) may be a potentially beneficial intervention for disorders characterized by bodily symptoms or feelings of disconnection from the self, including FND. Generally, DMT is based on the premise that psychological and bodily experiences reciprocally influence one another and has been shown to improve health-related psychological outcomes and wellbeing in a range of populations (e.g., fibromyalgia, brain trauma). Previous research has shown promise for body-based approaches for the treatment of dissociation and trauma-related distress, encouraging individuals to attend to their bodies/bodily sensations.

Previous research demonstrates reductions in bodily disconnection post-DMT in individuals with Depersonalization-Derealization disorder, a dissociative disorder that, like FND, involves disconnections from the self and surroundings and alterations to bodily awareness (lack of trusting the body, difficulties with attention regulation). Using structured DMT for FND may help to encourage a conscious connection to the body/surroundings in the here and now, as well as a recognition of bodily states and, in turn, an adaptive regulation of them. The feasibility of dance/movement therapy has not yet been tested in FND and may provide new avenues for treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

One research team member, leading the collection of laboratory data and inputting secondary outcome measures, will be blinded to group assignment. Participants will be reminded not to disclose information related to group allocation to this team member to prevent possible bias during the trial.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 or older
  • Fluency in English language
  • Normal or corrected eyesight
  • Primary diagnosis of FND with seizures, motor symptoms, sensory symptoms, or mixed FND symptoms
  • Participants will be asked to provide proof of FND diagnosis in the form of an existing medical letter from a qualified healthcare professional (not required to be from an NHS service). This will be checked prior to engaging in the screening interview for the study.

排除标准

  • Physical symptoms or disability that would prohibit the participant's ability to engage with the intervention and/or attend the in-person sessions (e.g., upper/lower limb paralysis, seizure frequency > 10 per day, severe tremor)
  • A diagnosis of functional cognitive disorder or functional cognitive symptoms only
  • Current participation in another body-based therapy or intervention for FND - participants currently engaging in some form of body- based therapy, whether self-guided or therapist-guided, will be asked to abstain from these sessions during the course of this study. If this is not feasible, the participant will be excluded from the current study.
  • Current comorbid diagnosis of a major neurological (e.g., epilepsy, Parkinson's), psychiatric (e.g., schizophrenia, active psychosis, severe alcohol or substance use disorder), or cardiovascular (e.g., coronary artery disease, heart failure) disorder that may impair the participant's ability to participate in the study and confound the results

研究组 & 干预措施

Structured dance/movement therapy

Experimental

Participants will receive a structured dance/movement therapy programme over a period of five weeks

干预措施: Structured dance/movement (Other)

Physical exercise/body coordination

Active Comparator

Participants will receive a physical exercise/body coordination programme over a period of five weeks

干预措施: Physical exercise/body coordination (Other)

结局指标

主要结局

Feasibility of the intervention: Recruitment

时间窗: Up to 16 weeks

The number/proportion of eligible participants who consent to participate in the study by 29/05/2026

Feasibility of the intervention: Adherence

时间窗: Up to 20 weeks

The number/proportion of in-person visits and mid-point calls attended and completed. The number of days the task was completed during the at-home periods.

Feasibility of the intervention: Withdrawal

时间窗: Up to 20 weeks

The number/proportion of enrolled (consented) participants who withdraw from the study prior to completion.

Feasibility of the intervention: Adverse events

时间窗: Up to 20 weeks

The number and nature of adverse events reported during study participation.

Feasibility of the intervention: Acceptability

时间窗: Up to 20 weeks

Qualitative measures of perceived benefit of the intervention, barriers and facilitating factors, experiences of study procedures.

次要结局

  • Clinical Global Impression - Improvement Scale(Baseline, Week 2.5, Week 5, Week 9)
  • Functional Neurological Symptoms Questionnaire(Baseline, Week 2.5, Week 5, Week 9)
  • Multidimensional Assessment of Interoceptive Awareness - 2(Baseline, Week 2.5, Week 5, Week 9)
  • Five Facet Mindfulness Questionnaire(Baseline, Week 2.5, Week 5, Week 9)
  • Cognitive Behavioural Response Questionnaire - Short Form(Baseline, Week 2.5, Week 5, Week 9)
  • Multiscale Dissociation Inventory(Baseline, Week 2.5, Week 5, Week 9)
  • Toronto Alexithymia Scale - 20(Baseline, Week 2.5, Week 5, Week 9)
  • Work & Social Adjustment Scale(Baseline, Week 2.5, Week 5, Week 9)
  • Short-Form Health Survey(Baseline, Week 2.5, Week 5, Week 9)
  • Body Perception Questionnaire - ANS(Baseline, Week 2.5, Week 5, Week 9)
  • Body Perception Questionnaire - VSF(Baseline, Week 2.5, Week 5, Week 9)
  • Cardiac interoceptive accuracy(Day 1 baseline, Day 1 post single intervention session, Week 5)
  • Cardiac interoceptive confidence(Day 1 baseline, Day 1 post single intervention session, Week 5)
  • Time estimation accuracy(Day 1 baseline, Day 1 post single intervention session, Week 5)
  • Time estimation confidence(Day 1 baseline, Day 1 post single intervention session, Week 5)
  • Physiological and psychological states(Day 1 baseline, Day 1 post single intervention session, Week 5)
  • Autonomic arousal(Day 1 baseline, Day 1 post single intervention session, Week 5)
  • At-home Diary Sheet: ease of task performance(Day 3, Day 6, Day 9, Day 12, Day 15, Day 18, Day 21, Day 24, Day 27, Day 30)
  • At-home Diary Sheet: feeling during task performance(Day 3, Day 6, Day 9, Day 12, Day 15, Day 18, Day 21, Day 24, Day 27, Day 30)
  • At-home Diary Sheet: physical states(Day 3, Day 6, Day 9, Day 12, Day 15, Day 18, Day 21, Day 24, Day 27, Day 30)
  • At-home Diary Sheet: state dissociation(Day 3, Day 6, Day 9, Day 12, Day 15, Day 18, Day 21, Day 24, Day 27, Day 30)
  • At-home Diary Sheet: autonomic arousal(Day 3, Day 6, Day 9, Day 12, Day 15, Day 18, Day 21, Day 24, Day 27, Day 30)
  • At-home Diary Sheet: open comments(Day 3, Day 6, Day 9, Day 12, Day 15, Day 18, Day 21, Day 24, Day 27, Day 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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