Mirror Therapy Rehabilitation for Motor Functional Neurological Disorders.

NCT04739176 | Completed

• 1 other identifier: 69HCL20_1094
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

functional neurological disorder; computerized mirror therapy; actimeter; body schema; quality of life; manual dexterity; single case experimental design; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in upper limb motor activity

  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.

  Continuous measurements over 24 hours, 7 days a week, during the 9 weeks of study participation

• Change in the evaluation of achievement of the patient's rehabilitation objectives using the Goal Attainment Scale (GAS)

  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.

  Once a week during patient participation (9 weeks)

Secondary Outcomes (4)

• Manual dexterity assessment using the Box and Block Test

  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)

• Subjective assessment of pain using a visual analog scale

  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

Study Arms (1)

One-on-one rehabilitation program

EXPERIMENTAL

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

Interventions

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

One-on-one rehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Henry Gabrielle - Hospices Civils de Lyon

Saint-Genis-Laval, 69230, France

Location

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 4, 2021
• Study Start: March 9, 2021
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

FR (1)