Condition category
Nervous System Diseases
Date applied
29/06/2006
Date assigned
29/06/2006
Last edited
07/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

Department of Rehabilitation
P.O. Box 85500
Utrecht
3508 CA
Netherlands

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes