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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Improvement in upper extremity motor function using ARMT versus CT alone
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 3
2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy
干预措施: Conventional therapy (Other)
Group 1
2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy
干预措施: Conventional therapy (Other)
Group 1
2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy
干预措施: ARMT (Other)
Group 1
2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy
干预措施: cortical reactivity (Other)
Group 1
2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy
干预措施: Fluidity of movement (Other)
Group 2
3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy
干预措施: Conventional therapy (Other)
Group 2
3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy
干预措施: ARMT (Other)
Group 2
3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy
干预措施: cortical reactivity (Other)
Group 2
3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy
干预措施: Fluidity of movement (Other)
Group 3
2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy
干预措施: ARMT (Other)
Group 3
2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy
干预措施: cortical reactivity (Other)
Group 3
2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy
干预措施: Fluidity of movement (Other)
结局指标
主要结局
Improvement in upper extremity motor function using ARMT versus CT alone
时间窗: 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.
次要结局
- Improvement n perceived pain at movement and at rest using ARMT versus CT alone(Daily until study end (10 weeks))
- Improvement in quality of life using ARMT versus CT alone(Every Monday and Thursday until study end (10 weeks))
- Improvement of mental imagery ability using ARMT versus CT alone(Every Monday and Thursday until study end (10 weeks))
- 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))
- Improvement in deep proprioceptive sensitivity of the upper limb using ARMT versus CT alone(Every Monday and Thursday until study end (10 weeks))
- Improvement in clinical signs of CRPS using ARMT versus CT alone(Every Monday and Thursday until study end (10 weeks))
- Improvement in global impression of change using ARMT versus CT alone(Every Monday and Thursday until study end (10 weeks))
- 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))
- 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))
- 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))
- 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))
- 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))