Patients with chronic idiopathic axonal polyneuropathy: relationships in the disablement process
| ISRCTN | ISRCTN29920470 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29920470 |
| Secondary identifying numbers | 2006-01 |
- 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
Scientific
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 |
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/03/2006 |
| Completion date | 01/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
3508 GA
Netherlands
Sponsor information
University Medical Center Utrecht (UMCU) (The Netherlands)
University/education
University/education
Department of Rehabilitation
P.O. Box 85500
Utrecht
3508 CA
Netherlands
"ROR" |
https://ror.org/0575yy874 |
|---|
Funders
Funder type
University/education
University Medical Center Utrecht (UMCU) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
