Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity
- Conditions
- Complex Regional Pain Syndromes
- Interventions
- Other: Conventional therapyOther: ARMTOther: cortical reactivityOther: Fluidity of movement
- Registration Number
- NCT05787119
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 7
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3 ARMT 2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy Group 1 Fluidity of movement 2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy Group 2 ARMT 3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy Group 1 cortical reactivity 2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy Group 1 ARMT 2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy Group 1 Conventional therapy 2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy Group 3 Fluidity of movement 2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy Group 2 Conventional therapy 3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy Group 2 cortical reactivity 3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy Group 3 cortical reactivity 2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy Group 2 Fluidity of movement 3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy Group 3 Conventional therapy 2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy
- Primary Outcome Measures
Name Time Method Improvement in upper extremity motor function using ARMT versus CT alone Every Monday and Thursday until study end (10 weeks) 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
Name Time Method Improvement n perceived pain at movement and at rest using ARMT versus CT alone Daily until study end (10 weeks) Change in pain, reported on a 0-10 visual analog scale
Improvement in quality of life using ARMT versus CT alone Every Monday and Thursday until study end (10 weeks) 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 of mental imagery ability using ARMT versus CT alone Every Monday and Thursday until study end (10 weeks) 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
evolution of cortical reactivity or event-related potential (ERP) between the healthy and pathological sides following a rehabilitation program adding a TMRA device. at the end of the study (10 weeks) Amplitude of signal power (in microVolts) in motor imagery task and motor execution task compared with a resting task
Improvement in deep proprioceptive sensitivity of the upper limb using ARMT versus CT alone Every Monday and Thursday until study end (10 weeks) 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 in clinical signs of CRPS using ARMT versus CT alone Every Monday and Thursday until study end (10 weeks) Change in Complex regional pain syndrome Severity Score (CSS); score out of 16
Improvement in global impression of change using ARMT versus CT alone Every Monday and Thursday until study end (10 weeks) 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.
effectiveness of a rehabilitation program adding a TMRA device on smoothness of movement on the pathological limb between pre- and post-treatment Before Intervention (Day 0) and at the end of the study (10 weeks) Leap Motion Control motion capture device from Ultraleap Company (description)
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. Before Intervention (Day 0) and at the end of the study (10 weeks) 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. Before Intervention (Day 0) and at the end of the study (10 weeks) Multiple correlation (adimentional)
To compare the smoothness of movement between the healthy and pathological side following a rehabilitation programme adding a TMRA device. at the end of the study (10 weeks) Amplitude of signal power in motor imagery task and motor execution task compared with a resting task (descriptive, adimentional)
effectiveness of rehabilitation program adding TMRA device on cortical reactivity or Event related Potential (ERP) between pre- and post-treatment on pathological limb Before Intervention (Day 0) and at the end of the study (10 weeks) Measurement of signal power amplitude (in microVolts) in motor imagery task and motor execution task compared with a resting task
Trial Locations
- Locations (1)
CHU de Nîmes
🇫🇷Nîmes, France