Clinical trial NCT04739176: Mirror Therapy Rehabilitation for Motor Functional Neurological Disorders.
Official title: Evaluation of the Therapeutic Benefit of Rehabilitation With Computerized Mirror Therapy for Patients Suffering From Motor Neurological Disorder (FND) of the Upper Limb.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Neurological Symptom Disorder
Keywords: functional neurological disorder
computerized mirror therapy
actimeter
body schema
quality of life
manual dexterity
single case experimental design
rehabilitation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in upper limb motor activity
timeFrame: Continuous measurements over 24 hours, 7 days a week, during the 9 weeks of study participation
measure: Change in the evaluation of achievement of the patient's rehabilitation objectives using the Goal Attainment Scale (GAS)
timeFrame: Once a week during patient participation (9 weeks)
Secondary outcomes:
measure: Manual dexterity assessment using the Box and Block Test
timeFrame: Once a week during patient participation (9 weeks)
measure: Subjective assessment of quality of life using a visual analog scale
timeFrame: Once a week during patient participation (9 weeks)
measure: Subjective assessment of pain using a visual analog scale
timeFrame: Once a week during patient participation (9 weeks)
measure: Evaluation of the body's mental representation capacities using a laterality judgement task
timeFrame: Once a week during patient participation (9 weeks) for the mental representation of the hand, once every 3 weeks for other body parts
Other outcomes:
Locations:
city: Saint-Genis-Laval
country: France
facility: Hôpital Henry Gabrielle - Hospices Civils de Lyon
Study officials:
References: