Mirror Therapy Rehabilitation for Motor Functional Neurological Disorders.

NCT ID: NCT04739176

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2023-12-08

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.

Conditions

Functional Neurological Symptom Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One-on-one rehabilitation program

Group Type: EXPERIMENTAL

One-on-one rehabilitation program including computerized mirror therapy in addition to standard rehabilitation.

Intervention Type: OTHER

atients will be admitted to the day hospital 2 days a week for 9 weeks. They will participate in a one-on-one rehabilitation program conducted by a multidisciplinary team including a physiotherapist, psychomotor therapist, occupational therapist and a physical activity monitor. Patients will also participate in 12 computerized mirror therapy sessions (twice a day, 2 days a week, from week 4 to 6 of the program).

Interventions

One-on-one rehabilitation program including computerized mirror therapy in addition to standard rehabilitation.

atients will be admitted to the day hospital 2 days a week for 9 weeks. They will participate in a one-on-one rehabilitation program conducted by a multidisciplinary team including a physiotherapist, psychomotor therapist, occupational therapist and a physical activity monitor. Patients will also participate in 12 computerized mirror therapy sessions (twice a day, 2 days a week, from week 4 to 6 of the program).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Henry Gabrielle - Hospices Civils de Lyon

Saint-Genis-Laval, , France

Countries

France

Other Identifiers

69HCL20_1094

Identifier Type: -

Identifier Source: org_study_id