Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- 10-meter Walk Test
研究概览
简要总结
The project aims to investigate the validity, and reliability of outcome measures of muscle strength, functioning (gait, balance, and fine motor skills), physical activity, and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy. Further, the project aims to compare physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy with physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills) and daily living in healthy adults.
详细描述
In four phases the investigators will evaluate physical activity and the validity, reliability, and responsiveness of the outcome measures in patients with polyneuropathy. During the four phases clinical outcome measures, patient-reported outcomes measures, and accelerometer data on physical activity will be evaluated. The investigators plan to include 400 adult patients with polyneuropathy (acquired, hereditary, and idiopathic) from our clinic and 120 adult healthy controls. The 400 patients with polyneuropathy include the following subtypes of polyneuropathy: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), vasculitis polyneuropathy, Polyneuropathy-Organomegaly-Endocrinopathy-Monoclonal protein-Skin changes (POEMS syndrome), Multifocal Motor Neuropathy (MMN), Charcot Marie Tooth (CMT), hATTR amyloidosis, Diabetic Polyneuropathy (DPN), and idiopathic neuropathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria patients:
- •> 18 years Diagnosed with polyneuropathy (verified by nerve conduction)
- •Inclusion Criteria healthy controls:
- •> 18 years Healthy
排除标准
- •Exclusion Criteria patients:
- •Not verified polyneuropathy
- •Exclusion Criteria healthy controls:
- •Diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy
研究组 & 干预措施
Patients with polyneuropathy
Adults (> 18 years) diagnosed with polyneuropathy
干预措施: Validity and reliability of outcome measures in polyneuropathy (Other)
Healthy controls
Healthy adults (>18 years)
干预措施: Healthy controls (Other)
结局指标
主要结局
10-meter Walk Test
时间窗: At baseline (study entry), after 2-4 weeks, and after 1-2 years
The patient is asked to 10 meter as fast as possible
Six Spot Step Test
时间窗: At baseline (study entry), after 2-4 weeks, and after 1-2 years
The patient is instructed to walk 5 meters as fast as possible, while kicking five cylinder blocks out of five circles marked on the floor.
Dynamic Gait Index
时间窗: At baseline, after 2-4 weeks, and after 1-2 years
The patient will be asked to walk while performing different tasks (walking: normally, while changing speed, while turning head (vertical and horizontal), while turning around, while stepping over obstacles, and walking stairs).
Nine Hole Peg Test
时间窗: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Fine motor skills
Jamar Hand-grip dynamometer (hand-grip-strength)
时间窗: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Best of three values
Isometric strength measured with hand-held dynamometer
时间窗: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Will be tested bilateral at ankle, knee, wrist and elbow
Isokinetic muscle strength measured with Biodex System 3 or 4 PRO, Biodex Medical Systems
时间窗: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Will be tested bilateral at ankle and knee
6-minute Walk Test
时间窗: At baseline (study entry), after 2-4 weeks, and after 1-2 years
The patient will be asked to walk back and forth along a 25 meter walkway for six minutes. They will be instructed to walk as far as possible for six minutes.
30 seconds Chair Stand Test
时间窗: At baseline (study entry), after 2-4 weeks, and after 1-2 years
The patients will be asked to stand up and sit down as many times as possible in 30 secs with their arms across their chest
SENS motion activity sensor (accelerometer)
时间窗: At baseline (study entry), and after 1-2 years
The SENS motion activity sensor is a wearable accelerometer. It measures physical activity by collecting raw data of accelerations. Data on active time, sedentary time, time spent walking and number of steps taken will be collected. The sensor will be attached and worn 24/7 (the sensor will be worn the week following baseline tests, and the week after tests at visit three (1-2 years after baseline).
Inflammatory Neuropathy Cause and Treatment (INCAT)
时间窗: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Interview based disability scale INCAT evaluates disability of the upper and lower limb. The total INCAT score ranges from 0-10 (low scores indicating no disability and higher scores indicating higher level of disability).
次要结局
- Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS)(At baseline (study entry), after 2-4 weeks, and after 1-2 years)
- Physical Activity Scale (PAS2)(At baseline (study entry), after 2-4 weeks, and after 1-2 years)
- Falls Efficacy Scale-International (FES-I)(At baseline (study entry), after 2-4 weeks, and after 1-2 years)
- Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS)(At baseline (study entry), after 2-4 weeks, and after 1-2 years)
- Fatigue Severity Scale (FSS)(At baseline (study entry), after 2-4 weeks, and after 1-2 years)
- PittsburghSleep Quality Index(At baseline (study entry), after 2-4 weeks, and after 1-2 years)
- International Physical Activity Questionaire (IPAQ)(At baseline (study entry), after 2-4 weeks, and after 1-2 years)
- Composite Autonomic Symptom Score (COMPAS-31)(At baseline (study entry), after 2-4 weeks, and after 1-2 years)
- Major Depression Inventory (MDI)(At baseline (study entry), after 2-4 weeks, and after 1-2 years)
研究者
Britt Stævnsbo Pedersen
Principal Investigator
Rigshospitalet, Denmark