Back to resultsBenefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity (REFLEXION)
Primary Purpose
Complex Regional Pain Syndromes
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Conventional therapy
ARMT
cortical reactivity
Fluidity of movement
Sponsored by
About this trial
This is an interventional other trial for Complex Regional Pain Syndromes focused on measuring Mirror Movement Therapy, Physical Therapy Modalities
Eligibility Criteria
Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan Patient with CRPS of the upper limb according to the Budapest criteria. Patient newly treated at the Centre d'Evaluation et de Traitement de la Douleur of the CHU of Nîmes. Patient with a diagnosis of CRPS for more than 3 months Exclusion Criteria: The subject is participating in a therapeutic study, or is in a period of exclusion determined by a previous study The subject unable to express consent It is impossible to give the subject informed information The patient is under safeguard of justice or state guardianship Patient is pregnant, parturient or breastfeeding Patient with medically significant visual impairment that is incompatible with the practice of ARMT Patient with CRPS secondary to a stroke Patient with cognitive disorders (Montreal Cognitive Assessment scale less than 26) Patient with Unilateral Spatial Negligence according to the Bell's test Patient with arthrodesis of one of the joints of the upper limbs. Patient with an unhealed fracture of one of the upper limbs
Sites / Locations
- CHU de NîmesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy
3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy
2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy
Outcomes
Primary Outcome Measures
Improvement in upper extremity motor function using ARMT versus CT alone
Change in Box and Block Test (BBT) score. The score will be compared between the right and left hand and against reference values according to age and sex.
Secondary Outcome Measures
Improvement in clinical signs of CRPS using ARMT versus CT alone
Change in Complex regional pain syndrome Severity Score (CSS); score out of 16
Improvement in quality of life using ARMT versus CT alone
Change in EQ-5D-3L questionnaire score. The first part is a score out of 15 total (scoring out of 3 per item). The second part is a scale numbered 0 to 100 (0 being the worst health imaginable to 100 being the best health imaginable).
Improvement in global impression of change using ARMT versus CT alone
Change in Patient Global Impression of Change (PGIC) Questionnaire score. The measurement is between 1 and 7. It is a qualitative scale converted into a numerical scale.
Improvement in deep proprioceptive sensitivity of the upper limb using ARMT versus CT alone
Change in proprioceptive section of the Rivermead Assessment of Somatosensory Performance questionnaire score. 5 joints are tested 6 times. Thus for each joint, the score is out of 6, for a total score of 30.
Improvement of mental imagery ability using ARMT versus CT alone
Change in mental chronometry. Measured using a modified Box and Block Test to give a ratio = (real task time - imagined task time) / real task time
Improvement n perceived pain at movement and at rest using ARMT versus CT alone
Change in pain, reported on a 0-10 visual analog scale
effectiveness of rehabilitation program adding TMRA device on cortical reactivity or Event related Potential (ERP) between pre- and post-treatment on pathological limb
Measurement of signal power amplitude (in microVolts) in motor imagery task and motor execution task compared with a resting task
evolution of cortical reactivity or event-related potential (ERP) between the healthy and pathological sides following a rehabilitation program adding a TMRA device.
Amplitude of signal power (in microVolts) in motor imagery task and motor execution task compared with a resting task
effectiveness of a rehabilitation program adding a TMRA device on smoothness of movement on the pathological limb between pre- and post-treatment
Leap Motion Control motion capture device from Ultraleap Company (description)
To compare the smoothness of movement between the healthy and pathological side following a rehabilitation programme adding a TMRA device.
Amplitude of signal power in motor imagery task and motor execution task compared with a resting task (descriptive, adimentional)
Correlate the power of cortical reactivity with fluidity of movement, function, mental chronometry, quality of life, global impression of change, proprioceptive sensitivity and clinical criteria of severity.
Correlation between 2 signals: cortical and motor for motor execution tasks (adimentional)
Correlate fluidity of movement with the power of cortical reactivity, function, mental chronometry, quality of life, global impression of change, proprioceptive sensitivity and clinical criteria of severity.
Multiple correlation (adimentional)
Full Information
NCT ID
NCT05787119
First Posted
March 10, 2023
Last Updated
October 4, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT05787119
Brief Title
Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity
Acronym
REFLEXION
Official Title
Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity: a Single Case Experimental Design (SCED) Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Complex Regional Pain Syndrome (CRPS) is a "polymorphic joint and periarticular pain syndrome associated with various changes in sensitivity, vasomotor, sudomotor, muscular and trophic changes". The diagnostic criteria of the disease follow the Budapest criteria, namely (i) vasomotor disorders (temperature asymmetry, color changes), (ii) sudomotor/oedema (sweating changes, edema), (iii) sensory (hyperesthesia, allodynia, hyperalgesia) and (iv) motor/trophic (reduced joint mobility, weakness, tremor, dystonia, trophic disorders of skin, nails, hair).
Of the many treatments, augmented reality mirror therapy (ARMT), is novel in substituting a virtual environment for part of the real environment. This type of device has never been studied from a clinical point of view in the treatment of upper limb CRPS, whereas fMRI and clinical dissertation studies have suggested an improvement in neuroplasticity.
The aim of this study is to establish the clinical effects of ARMT on CRPS, and to evaluate its benefit within a conventional rehabilitation treatment (physiotherapy and occupational therapy).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes
Keywords
Mirror Movement Therapy, Physical Therapy Modalities
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy
Arm Title
Group 2
Arm Type
Experimental
Arm Description
3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy
Arm Title
Group 3
Arm Type
Experimental
Arm Description
2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
The CT consists of 1 session of 30 minutes of physical therapy (type of re-education established according to the pain at rest and during movement assessed every day) and 1 session of 30 minutes of occupational therapy (type of re-education established according to the pain at rest and during movement assessed every day). CT is performed 5 days a week.
Intervention Type
Other
Intervention Name(s)
ARMT
Intervention Description
The ARMT consists of 1 session of 30 minutes (type of rehabilitation established according to the pain at rest and during movement evaluated daily). ARMT is performed 5 days a week for 1 month.
Intervention Type
Other
Intervention Name(s)
cortical reactivity
Intervention Description
An electroencephalogram was taken at the start and end of the study to study cortical reactivity during the performance of 3 different tasks repeated 30 times: a resting task (consisting of looking at a cross on a screen), a motor imagery task (consisting of imagining performing wrist flexions/extensions) and a motor execution task (consisting of performing wrist flexions/extensions).
Intervention Type
Other
Intervention Name(s)
Fluidity of movement
Intervention Description
Motion capture at the start and end of the study to study the fluidity of movement during 3 different tasks repeated 30 times: a resting task (looking at a cross on a screen), a motor imagery task (imagining wrist flexions/extensions) and a motor execution task (performing wrist flexions/extensions).
Primary Outcome Measure Information:
Title
Improvement in upper extremity motor function using ARMT versus CT alone
Description
Change in Box and Block Test (BBT) score. The score will be compared between the right and left hand and against reference values according to age and sex.
Time Frame
Every Monday and Thursday until study end (10 weeks)
Secondary Outcome Measure Information:
Title
Improvement in clinical signs of CRPS using ARMT versus CT alone
Description
Change in Complex regional pain syndrome Severity Score (CSS); score out of 16
Time Frame
Every Monday and Thursday until study end (10 weeks)
Title
Improvement in quality of life using ARMT versus CT alone
Description
Change in EQ-5D-3L questionnaire score. The first part is a score out of 15 total (scoring out of 3 per item). The second part is a scale numbered 0 to 100 (0 being the worst health imaginable to 100 being the best health imaginable).
Time Frame
Every Monday and Thursday until study end (10 weeks)
Title
Improvement in global impression of change using ARMT versus CT alone
Description
Change in Patient Global Impression of Change (PGIC) Questionnaire score. The measurement is between 1 and 7. It is a qualitative scale converted into a numerical scale.
Time Frame
Every Monday and Thursday until study end (10 weeks)
Title
Improvement in deep proprioceptive sensitivity of the upper limb using ARMT versus CT alone
Description
Change in proprioceptive section of the Rivermead Assessment of Somatosensory Performance questionnaire score. 5 joints are tested 6 times. Thus for each joint, the score is out of 6, for a total score of 30.
Time Frame
Every Monday and Thursday until study end (10 weeks)
Title
Improvement of mental imagery ability using ARMT versus CT alone
Description
Change in mental chronometry. Measured using a modified Box and Block Test to give a ratio = (real task time - imagined task time) / real task time
Time Frame
Every Monday and Thursday until study end (10 weeks)
Title
Improvement n perceived pain at movement and at rest using ARMT versus CT alone
Description
Change in pain, reported on a 0-10 visual analog scale
Time Frame
Daily until study end (10 weeks)
Title
effectiveness of rehabilitation program adding TMRA device on cortical reactivity or Event related Potential (ERP) between pre- and post-treatment on pathological limb
Description
Measurement of signal power amplitude (in microVolts) in motor imagery task and motor execution task compared with a resting task
Time Frame
Before Intervention (Day 0) and at the end of the study (10 weeks)
Title
evolution of cortical reactivity or event-related potential (ERP) between the healthy and pathological sides following a rehabilitation program adding a TMRA device.
Description
Amplitude of signal power (in microVolts) in motor imagery task and motor execution task compared with a resting task
Time Frame
at the end of the study (10 weeks)
Title
effectiveness of a rehabilitation program adding a TMRA device on smoothness of movement on the pathological limb between pre- and post-treatment
Description
Leap Motion Control motion capture device from Ultraleap Company (description)
Time Frame
Before Intervention (Day 0) and at the end of the study (10 weeks)
Title
To compare the smoothness of movement between the healthy and pathological side following a rehabilitation programme adding a TMRA device.
Description
Amplitude of signal power in motor imagery task and motor execution task compared with a resting task (descriptive, adimentional)
Time Frame
at the end of the study (10 weeks)
Title
Correlate the power of cortical reactivity with fluidity of movement, function, mental chronometry, quality of life, global impression of change, proprioceptive sensitivity and clinical criteria of severity.
Description
Correlation between 2 signals: cortical and motor for motor execution tasks (adimentional)
Time Frame
Before Intervention (Day 0) and at the end of the study (10 weeks)
Title
Correlate fluidity of movement with the power of cortical reactivity, function, mental chronometry, quality of life, global impression of change, proprioceptive sensitivity and clinical criteria of severity.
Description
Multiple correlation (adimentional)
Time Frame
Before Intervention (Day 0) and at the end of the study (10 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
Patient with CRPS of the upper limb according to the Budapest criteria.
Patient newly treated at the Centre d'Evaluation et de Traitement de la Douleur of the CHU of Nîmes.
Patient with a diagnosis of CRPS for more than 3 months
Exclusion Criteria:
The subject is participating in a therapeutic study, or is in a period of exclusion determined by a previous study
The subject unable to express consent
It is impossible to give the subject informed information
The patient is under safeguard of justice or state guardianship
Patient is pregnant, parturient or breastfeeding
Patient with medically significant visual impairment that is incompatible with the practice of ARMT
Patient with CRPS secondary to a stroke
Patient with cognitive disorders (Montreal Cognitive Assessment scale less than 26)
Patient with Unilateral Spatial Negligence according to the Bell's test
Patient with arthrodesis of one of the joints of the upper limbs.
Patient with an unhealed fracture of one of the upper limbs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud DUPEYRON
Phone
04.66.68.34.59
Email
arnaud.DUPEYRON@umontpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud DUPEYRON
Organizational Affiliation
CHU de Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30129
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari, Pr
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Arnaud Dupeyron
First Name & Middle Initial & Last Name & Degree
Gabriel COHEN-AKNINE
12. IPD Sharing Statement
Learn more about this trial
Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity
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