Patients with chronic idiopathic axonal polyneuropathy: relationships in the disablement process

ISRCTN	ISRCTN29920470
DOI	https://doi.org/10.1186/ISRCTN29920470
Protocol serial number	2006-01
Sponsor	University Medical Center Utrecht (UMCU) (The Netherlands)
Funder	University Medical Center Utrecht (UMCU) (The Netherlands)

Submission date: 29/06/2006
Registration date: 29/06/2006
Last edited: 07/03/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr N.L.U. van Meeteren
Scientific

University Medical Center Utrecht
Department of Neurology and Neurosurgery
Rudolf Magnus Institute of Neuroscience
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Email	n.vanmeeteren@umcutrecht.nl

Study information

Primary study design	Observational
Study design	Longitudinal study; one patient group with CIAP in which the health status will be monitored
Secondary study design	Cohort study
Scientific title
Study acronym	EXAMPLE part II
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	90
Key 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
Key exclusion criteria	1. Relevant co-morbidity, expected to influence the test results 2. Anticipated health risks during performance-based testing
Date of first enrolment	01/03/2006
Date of final enrolment	01/03/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Utrecht

Utrecht
3508 GA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan