Fear of Falling in Muscular Dystrophy: Investigation of the Phenomenon and a Multidisciplinary Rehabilitation Approach to Treat it
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Falls Efficacy Scale-International (FES-I)
研究概览
简要总结
Primary objectives
WP1: Evaluate the prevalence of FOF in the study population and how this varies over time. Evaluate whether there are relationships between the variables investigated (clinical, motor, cognitive, psychological) and the presence of FOF.
WP2: To evaluate, among those who presented disabling FOF, the effects of two different therapeutic approaches: motor rehabilitation vs. motor rehabilitation plus cognitive-behavioral psychotherapy.
Secondary objectives
WP1: To evaluate whether different profiles defined by specific clinical, motor, cognitive, psychological, and personological characteristics can be characterized among patients with dystrophy and FOF and how these impact functionality, activity, participation, and quality of life.
WP2: Evaluate the effects of cognitive-behavioral therapy (CBT) and a motor treatment on cognitive and psychological aspects, the frequency of falls, and the functional validity.
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
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of muscular dystrophy: myotonic, facio-scapular-humeral, Becker, cingulate, Emery-Dreifuss, and distal;
- •16 to 65 years of age;
- •Patients with residual walking capacity: functional ambulation category (FAC) at least equal to 1
- •MMSE corrected for age and education of 23,8 points.
- •Specific Work Package 2 (WP2) inclusion criterion:
- •the persistence of Fear Of Falling at 3 months, identified as a score of at least 16 points at the Falls efficacy scale - International (FES-I);
排除标准
- •The presence of factors that may lead to the assumption that it is a priori impossible to ensure adequate adherence to the proposed treatment;
- •Concurrent management in other rehabilitation centers or participation in other research projects
- •Language barrier;
- •Failure to sign informed consent.
研究组 & 干预措施
Motor Rehabilitation
Motor rehabilitation will be characterized by sessions of 45 minutes each with a patient (total sessions 36)
干预措施: Motor rehabilitation (Behavioral)
Motor rehabilitation + cognitive behavioral therapy
1 session per week of 45 minutes of cognitive behavioral therapy and 2 sessions per week of 45 minutes of motor rehabilitation. The length of the treatment is the same as the control group: 12 weeks for 12 CBT sessions and 24 motor rehabilitation sessions (a total of 36 sessions).
干预措施: Motor Rehabilitation and Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Falls Efficacy Scale-International (FES-I)
时间窗: The Falls Efficacy Scale - International (FES-I) will be administered at Baseline (T0), at 3 months (T1), at 6 months (T3), and at 9 months (T5).
it allows us to identify the severity of the fear of falling. It consists of 16 questions directed to the patient, each of which can receive a score from 1 (=not at all concerned) to 4 (=very concerned). The scale range is from 16 to 64, where a lower score indicates less fear of falling. Specifically, a score between 16-19 indicates absent/mild fear of falling, between 20-27 moderate, and between 28-64 high (Morgan et al., 2013).
次要结局
- North Star Ambulatory Assessment (NSAA)(it will be administered at 3 months (T1).)
- Posturographic examination(It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).)
- Amount of walking(It will be measured one week before and one week after the rehabilitation intervention using a pedometer)
- Falls history(It will be collected at Baseline (T0).)
- Barthel index (BI)(It will be administered at Baseline (T0).)
- Montreal Cognitive Assessment (MoCA)(It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).)
- Trail Making Test (TMT)(It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).)
- Modified Five-Point Test (MFPT)(It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).)
- Beck Depression Inventory-II (BDI)(It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).)
- State-Trait Anxiety Inventory (STAI)(It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).)
- The Big Five Observer (BFO)(It will be administered at 3 months (T1).)
- Short Form Health Survey questionnaire (SF-36)(It will be administered at 3 months (T1).)
研究者
Valentina Varalta
Doctor
Universita di Verona