Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Validity and reliability of outcome measures in polyneuropathy: Patients will be tested, answer patient reported outcome measures, and wear accelerometer at baseline after 2-4 weeks and after 1-2 years.

Healthy controls: Healthy controls will be tested, answer patient reported outcome measures, and wear accelerometer at baseline visit. There is no follow-up in the healthy control group.

Study 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.

Eligibility

Primary outcome measure(s)

• 10-meter Walk Test — 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 — 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.
• 6-minute Walk Test — 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 — 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
• Dynamic Gait Index — 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 — At baseline (study entry), after 2-4 weeks, and after 1-2 years
  Fine motor skills
• Jamar Hand-grip dynamometer (hand-grip-strength) — At baseline (study entry), after 2-4 weeks, and after 1-2 years
  Best of three values
• Isometric strength measured with hand-held dynamometer — 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 — At baseline (study entry), after 2-4 weeks, and after 1-2 years
  Will be tested bilateral at ankle and knee
• SENS motion activity sensor (accelerometer) — 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) — 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).

Trial sites (1)

Other trials for the same condition