Interoception and Sense of Movement in the Patient With Multiple Sclerosis: Proposal of a Rehabilitation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change in interoception
研究概览
简要总结
To evaluate the effectiveness of an experimental rehabilitative protocol with specific tasks for the improvement of body awareness and the motor scheme in the patient with multiple sclerosis (EDSS <2.5).
Primary outcome: improvement of the interoception (awareness of the body) and of the related motor capacity Secondary outcomes: improvement of balance and postural self-correction control
详细描述
Multiple sclerosis (MS) is a chronically progressive, disabling, autoimmune disease that affects the central nervous system causing a wide spectrum of sensory, motor, and neuropsychiatric signs and symptoms. In the great part of patients with MS, there is a cognitive deficit that can start already in the early stages of the disease. Disability related to the disease is usually investigated through the Expanded Disability Status Scale (EDSS), however, the scale does not evaluate some very disabling aspects of the disease such as diplopia, fatigue and the impact of cognitive disorders.
The posture and postural self-correction are dependent on the image that anyone have of his own body and on the perception of it in the space, both internal and external. In multiple sclerosis proprioception and interoception are often altered due to motor and cognitive impairment.
The investigators propose a rehabilitative protocol that combine postural rehabilitation with specific visual-spatial tasks, relaxation sessions with self-awareness improvement and cognitive rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple sclerosis for less than 10 years
- •Course of relapsing remitting type
- •Relapse-free for at least 30 days
- •EDSS score <2,5
- •FDA-approved disease-modifying therapy for at least 6 months
- •Public health guidelines for participating in physical activity
排除标准
- •Other concurrent neurological and psychiatric diseases (like schizophrenia, bipolar disorder I or II and substance abuse disorders)
- •Oncological diseases
- •Cardiovascular disease, pacemaker carrier
- •Rheumatological diseases
- •Scoliosis >20° Cobb
- •Previous surgery on the spine
- •Pregnancy
- •Other physiotherapy in progress
研究组 & 干预措施
Treatment group
Rehabilitative treatment protocol:
Therapeutic exercise 8 mono-weekly sessions, 5 patients per group, duration 60 minutes and two sessions of single treatment, duration 60 minutes (duration of treatment about two months, considering also any recovery sessions)
干预措施: Rehabilitative treatment protocol (Other)
Waiting list
Intervention: The WL patients will be taken into the same treatment at the end of the experimental protocol, after T2 evaluation. In this period they act like a control group.
结局指标
主要结局
Change in interoception
时间窗: At the end of the cycle 1 (60 days), and at follow-up (120 days)
Multidimensional Assessment of Interoceptive Awareness (MAIA) total score minimum 0 - 40 obtained by sum of the 8 subscales: noticing 0 - 5, not distracting 0 - 5, not worring 0 - 5, attention regulation 0 - 5, emotional awareness 0 - 5, self regolation 0 - 5, body listening 0 - 5, Trusting 0 - 5. Higher values represent a better outcome.
次要结局
- Change in posture(At the end of the cycle 1 (60 days), and at follow-up (120 days))
- Change in body image 1(At the end of the cycle 1 (60 days), and at follow-up (120 days))
- Change in balance 1(At the end of the cycle 1 (60 days), and at follow-up (120 days))
- Change in balance 2(At the end of the cycle 1 (60 days), and at follow-up (120 days))
- Change in QOL.(At the end of the cycle 1 (60 days), and at follow-up (120 days))
- Change in body image 2(At the end of the cycle 1 (60 days), and at follow-up (120 days))
研究者
Teresa Paolucci
Medical Doctor
University of Roma La Sapienza