Functional Neurological Symptom DisorderFND-mirrorNCT04739176
Mirror Therapy Rehabilitation for Motor Functional Neurological Disorders.
A study testing One-on-one rehabilitation program including computerized mirror therapy in addition to standard rehabilitation. in people with Functional Neurological Symptom Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Neurological Symptom Disorder
- What is being tested?
- One-on-one rehabilitation program including computerized mirror therapy in addition to standard rehabilitation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2021to 8 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Henry Gabrielle - Hospices Civils de Lyon
Saint-Genis-Laval, 69230
About this study
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.
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
- Being tested
- One-on-one rehabilitation program including computerized mirror therapy in addition to standard rehabilitation.
- Keywords
- functional neurological disorder, computerized mirror therapy, actimeter, body schema, quality of life, manual dexterity, single case experimental design, rehabilitation
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| One-on-one rehabilitation program | Experimental | Not described Receives: Other: One-on-one rehabilitation program including computerized mirror therapy in addition to standard rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Once a week during patient participation (9 weeks)
Secondary outcomes (4)
Manual dexterity assessment using the Box and Block Test
The Box and Block test is a simple and quick evaluation of global upper limb motricity with well established validity, test-retest reliability and inter-rater reproducibility.
The patient must use one hand to move as many cubes as possible from one side of the box to the other in 60 seconds. The 60-second test is repeated one time for each hand. The score is the number of blocks moved from one compartment to the other in 60 seconds and a separate score is established for each hand.
Measured: Once a week during patient participation (9 weeks)
Subjective assessment of quality of life using a visual analog scale
The visual analog scale provides a self-report measure of the burden of symptoms and associated disability.
Using a graduated, non-numerical scale the subject must move a cursor to the place that best represents their current quality of life. The examiner then transcribes the cursor position into a number between 0 and 10.
Measured: Once a week during patient participation (9 weeks)
Subjective assessment of pain using a visual analog scale
The visual analog scale provides a self-report measure of the burden of symptoms and associated disability.
Using a graduated, non-numerical scale the subject must move a cursor to the place that best represents their current pain intensity. The examiner then transcribes the cursor position into a number between 0 and 10.
Measured: Once a week during patient participation (9 weeks)
Evaluation of the body's mental representation capacities using a laterality judgement task
An implicit motor imagery task involving judging the laterality of body parts will be used to evaluate the evolution of each patient's mental representation capacities via two parameters : the response time and the percentage of correct answers.
This evaluation will be conducted using a computer program that presents photos of body parts in different postures and orientations. The patient must judge the laterality of each body part (for example: right or left hand, right or left foot).
Measured: Once a week during patient participation (9 weeks) for the mental representation of the hand, once every 3 weeks for other body parts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start9 Mar 2021
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological Symptom DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739176
- Sponsor's protocol ID
- 69HCL20_1094
- Acronym
- FND-mirror
- Status last verified
- Jan 2024
- First submitted
- 26 Jan 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04739176
- Acronym / sponsor ID
- FND-mirror / 69HCL20_1094
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One-on-one rehabilitation program | Experimental | Other: One-on-one rehabilitation program including computerized mirror therapy in addition to standard rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | One-on-one rehabilitation program |
Primary outcome
Change in upper limb motor activity
Time frame: 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)
Time frame: 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.
4 secondary outcomes
Manual dexterity assessment using the Box and Block Test
Time frame: Once a week during patient participation (9 weeks)
Subjective assessment of quality of life using a visual analog scale
Time frame: Once a week during patient participation (9 weeks)
Subjective assessment of pain using a visual analog scale
Time frame: Once a week during patient participation (9 weeks)
Evaluation of the body's mental representation capacities using a laterality judgement task
Time frame: Once a week during patient participation (9 weeks) for the mental representation of the hand, once every 3 weeks for other body parts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-on-one rehabilitation program including computerized mirror therapy in addition to standard rehabilitation. in people with Functional Neurological Symptom Disorder, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in upper limb motor activity (time frame: Continuous measurements over 24 hours, 7 days a week, during the 9 weeks of study participation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.