Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 520
- Locations
- 1
- Primary Endpoint
- 10-meter Walk Test
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Britt Stævnsbo Pedersen
Principal Investigator
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria patients:
- •\> 18 years Diagnosed with polyneuropathy (verified by nerve conduction)
- •Inclusion Criteria healthy controls:
- •\> 18 years Healthy
Exclusion Criteria
- •Exclusion Criteria patients:
- •Not verified polyneuropathy
- •Exclusion Criteria healthy controls:
- •Diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy
Outcomes
Primary Outcomes
10-meter Walk Test
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Fine motor skills
Jamar Hand-grip dynamometer (hand-grip-strength)
Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Best of three values
Isometric strength measured with hand-held dynamometer
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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).
Secondary Outcomes
- 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)