Contact information
Type
Scientific
Primary contact
Dr N.L.U. van Meeteren
ORCID ID
Contact details
University Medical Center Utrecht
Department of Neurology and Neurosurgery
Rudolf Magnus Institute of Neuroscience
P.O. Box 85500
Utrecht
3508 GA
Netherlands
n.vanmeeteren@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2006-01
Study information
Scientific title
Acronym
EXAMPLE part II
Study hypothesis
1. A specific set of variables of impairments are related or predictive of functional limitations and disabilities
2. A specific set of variables of functional limitations are related or predictive of disabilities
3. Psychological variables (defined by theory of planned behaviour [TPB], anxiety and depression) add to impairment variables in the prediction of functional limitation (in self-report and performance measures)
4. These psychological variables mediate the relationship between impairment and functional limitations
Ethics approval
Not provided at time of registration
Study design
Longitudinal study; one patient group with CIAP in which the health status will be monitored
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic idiopathic axonal polyneuropathy (CIAP)
Intervention
None: this is a longitudinal study with one patient group with chronic idiopathic axonal polyneuropathy (CIAP), in which the health status will be monitored
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Parameters of four domains of the disablement process will be measured:
1. Impairment: muscle strength (hand-held dynamometry), balance (Berg balance scale), sensory function (sensory modality score), pain (McGill pain questionnaire), fatigue (fatigue severity scale)
2. Functional limitations: walking (modified shuttle walk test), physical functioning (physical functioning performance 10 test), hand functioning (button test and disabilities of the arm, shoulder, and hand questionnaire), physical activity (DigiWalker stepcounter), problematic activities (McMaster-Toronto arthritis patient function preference questionnaire)
3. Disability: autonomy and participation (impact on participation and autonomy questionnaire and Rankin score)
4. Intra-individual risk factor: cognitions; intentions and perceptions of control (TPB questionnaire), emotions (hospital anxiety and depression scale)
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/03/2006
Overall trial end date
01/03/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with chronic idiopathic axonal polyneuropathy (CIAP), diagnosed on established criteria
2. Patients who write and speak the Dutch language well
3. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Relevant co-morbidity, expected to influence the test results
2. Anticipated health risks during performance-based testing
Recruitment start date
01/03/2006
Recruitment end date
01/03/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
Funders
Funder type
University/education
Funder name
University Medical Center Utrecht (UMCU) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary