Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorRigshospitalet, Denmark

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Patients will be recruited from a the neuromuscular clinic at Rigshopitalet, Copenjagen, Denmark

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Validity and reliability of outcome measures in polyneuropathy

    Other intervention

    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

    Other intervention

    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.

Treatment groups

520 Participants
are divided into 2 treatment groups
Group A: Patients with polyneuropathy1 intervention
Group B: Healthy controls1 intervention

Trial outcomes

Primary outcomes

1

10-meter Walk Test

The patient is asked to 10 meter as fast as possible

Time frame
At baseline (study entry), after 2-4 weeks, and after 1-2 years
2

Six Spot Step Test

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.

Time frame
At baseline (study entry), after 2-4 weeks, and after 1-2 years
3

6-minute Walk Test

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.

Time frame
At baseline (study entry), after 2-4 weeks, and after 1-2 years
4

30 seconds Chair Stand Test

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

Time frame
At baseline (study entry), after 2-4 weeks, and after 1-2 years

Secondary outcomes

1

Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS)

I-RODS is a 24-item patient reported outcome measure that measures disability. The raw score ranges from 0-48, with 0 indicating severe disability and higher scores indicating lower levels of disability.

Time frame
At baseline (study entry), after 2-4 weeks, and after 1-2 years
2

Falls Efficacy Scale-International (FES-I)

Assesses limitations related to fear of falling. FES-I is a 16-item patient reported outcome measure that measures fear of falling. The score ranges from 16-64, with higher scores indicating greater fear of falling.

Time frame
At baseline (study entry), after 2-4 weeks, and after 1-2 years
3

Composite Autonomic Symptom Score (COMPAS-31)

Assesses autonomic dysfunction Compass-31 is a patient reported outcome measure that measures autonomic dysfunction. Scores ranges from 0-100, with higher scores indicating more severe symptoms of autonomic dysfunction.

Time frame
At baseline (study entry), after 2-4 weeks, and after 1-2 years
4

Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS)

Assesses neuropathic pain S-LANSS is a patient reported outcome measure for identifying neuropathic pain.

Time frame
At baseline (study entry), after 2-4 weeks, and after 1-2 years

Other outcomes

Sponsors and contacts

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