Evaluation of the Therapeutic Benefit of Rehabilitation With Computerized Mirror Therapy for Patients Suffering From Motor Neurological Disorder (FND) of the Upper Limb.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in upper limb motor activity
研究概览
简要总结
Motor functional neurological disorders (FND) correspond to motor symptoms that are unexplained by an organic lesion but are due to cerebral dysfunction. Patients with these disorders have high rates of disability and health care utilization, and their quality of life is as impaired as that of patients with an "organic" disease. Accompanying these patients in their often-complex health journey represents a socio-economic and human challenge that demands interdisciplinary collaboration. Rehabilitation is seen as an important part of the therapy for motor FND. However, further research is needed to refine appropriate interventions and to create evidence-based recommendations. In this study, patients suffering from a functional neurological motor disorder of the upper limb will be included in a novel rehabilitation protocol that includes computerized mirror therapy. The study will used a multiple baseline, across subjects, single-case experimental design (SCED). In this type of design, each subject is his own control, with individual parameters being repeatedly measured in the presence and absence of the intervention of interest (computerized mirror therapy). Computerized mirror therapy could restore the coherence between the motor program and its execution. The investigators hypothesize that this process could re-normalize upper-limb motor activity and that this will have a beneficial impact on manual dexterity, quality of life, and mental representation capacities of the upper limb.
The objective of this project is to use the single case experimental design method to investigate the efficacy of rehabilitation with computerized mirror therapy for patients suffering from motor neurological disorders (FND) of the upper limb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old,
- •Included in the PULSES program (University Program of Liaison and Care for Somatoform Etiologies),
- •Announcement and explanation of the diagnosis already given to the patient,
- •Motivated to participate in the project,
- •Diagnosed with any type of motor functional neurological disorder : partial or complete deficits and abnormal movements,
- •With a lateralized disorder (limited to one hemi-body) involving at least the upper limb,
- •Disorder must primarily involve the distal part of the upper-limb (fingers, wrist),
- •Admitted to the day hospital at Henry Gabrielle Hospital during the study,
- •Given free, informed consent in writing after being informed orally and in writing of how the study will proceed.
排除标准
- •Patients with visual disorders such as uncorrected diplopia, blindness or low visual acuity (corrected or uncorrected),
- •Pregnant, parturient and breastfeeding women,
- •Patients under a legal protection measure such as guardianship or curatorship
- •Patients not affiliated to a social security scheme (French Social Security) or beneficiaries of a similar scheme.
结局指标
主要结局
Change in upper limb motor activity
时间窗: Continuous measurements over 24 hours, 7 days a week, during the 9 weeks of study participation
The actimeter will quantify the level of motor activity of each upper limb, defined by acceleration (number of movements per day that can be described as involving weak, moderate, or intense acceleration) and the number of continuous activities over a 24 hour period. We will compare the activity of the affected hand across the three experimental phases and between the affected and non-affected hands within each phase.
Change in the evaluation of achievement of the patient's rehabilitation objectives using the Goal Attainment Scale (GAS)
时间窗: Once a week during patient participation (9 weeks)
The GAS will be established and graded individually with the patient during the first visit, with a maximum of 2 objectives. The GAS produces a quantitative index of patient goal attainment that the patient determines at the beginning of the study with the help of a professional. The GAS is assessed weekly using a 5-point scale of -2 and +2. The scale allows each patient to set functional goals by scaling them gradually. The patient's initial level should be set at a score of -2 and the desired level should be set at 0, with +2 representing achievement beyond their initial goal.
次要结局
- Subjective assessment of pain using a visual analog scale(Once a week during patient participation (9 weeks))
- Subjective assessment of quality of life using a visual analog scale(Once a week during patient participation (9 weeks))
- Manual dexterity assessment using the Box and Block Test(Once a week during patient participation (9 weeks))
- Evaluation of the body's mental representation capacities using a laterality judgement task(Once a week during patient participation (9 weeks) for the mental representation of the hand, once every 3 weeks for other body parts)