Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change in Shoulder Rating Questionnaire (SRQ) score from baseline
研究概览
简要总结
This study evaluates the effect of a specific, multidisciplinary and personalized rehabilitation program compared to usual care, on motor control and functional disability in patients with neuralgic amyotrophy.
Half of the participants will start with the 17-week specific rehabilitation program while the other half will first continue their usual care for 17 weeks, after which they will also receive the 17-week specific rehabilitation program.
详细描述
Neuralgic amyotrophy (NA) is a common (incidence 1:1000) peripheral nervous system disorder caused by acute autoimmune inflammation of the brachial plexus, the nerve bundle going to the shoulder and arm. Many NA patients develop abnormal motor control of the shoulder region (i.e. scapular dyskinesia), which persists even after the peripheral nerve damage has recovered. This suggests that persistent scapular dyskinesia in NA may result from (mal)adaptive changes in the central motor system.
Clinical experience shows that the specific, multidisciplinary and personalized rehabilitation program, focused on cognitive motor control can restore scapular dyskinesia in NA patients. This indicates that impairments in the central motor system likely play a role in persistent scapular dyskinesia and that specific rehabilitation may restore any alterations in central motor control.
We hypothesize that the specific rehabilitation program, focused on cognitive motor control is more effective in improving functional disability than usual care and that it can reverse maladaptive changes in central motor control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Suspected) diagnosis of neuralgic amyotrophy
- •In subacute or chronic phase of neuralgic amyotrophy (>2 months after attack onset)
- •Right-handed
- •Neuralgic amyotrophy predominantly present in right upper extremity
- •Presence of scapular dyskinesia
排除标准
- •Patients in the acute phase of NA (characterized by severe pain and inflammation of the brachial plexus)
- •(Prior) NA attacks of the lumbosacral plexus or the left upper extremity
- •Sever comorbidity
- •Any (bio)mechanical constraints of the shoulder girdle
- •Any other central nervous system, neurological, or neuromuscular disorder
结局指标
主要结局
Change in Shoulder Rating Questionnaire (SRQ) score from baseline
时间窗: Baseline (0 weeks) and post-intervention (17 weeks)
Change in functional (dis)ability of the shoulder, arm and hand measured with the SRQ
Change in brain activity related to central motor control from baseline
时间窗: Baseline (0 weeks) and post-intervention (17 weeks)
Change in the magnitudes of mean functional Magnetic Resonance Imaging signal (Blood-oxygen-level dependent (BOLD) activity) related to motor imagery of the affected arm, quantifying changes in central motor control
次要结局
- Change in performance on motor imagery tasks assessing motor control(Baseline (0 weeks), post-intervention (17 weeks))
- Change in Disability of Shoulder, Arm and Hand (DASH) score from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in Checklist individual strength - subscale fatigue (CIS-fatigue) score from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in McGill Pain Questionnaire (MPQ) score from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in self-efficacy for performing energy conservation strategies assessment (SEPECSA) score from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in Utrecht scale for evaluation of rehabilitation-participation (USER-P) score from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in Pain self efficacy questionnaire (PSEQ) score from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in Patient activation measure (PAM) score from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in Short-form 36 (SF-36) score from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in serratus anterior muscle strength from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in shoulder endorotation strength from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in shoulder exorotation strength from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in key grip strength from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in pinch grip strength from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in hand grip strength from baseline(Baseline (0 weeks), post-intervention (17 weeks))
- Change in reachable workspace from baseline(Baseline (0 weeks), post-intervention (17 weeks))