The aim of the present study is: Primary objectives:1. To determine the health status of children and (young)adults with OBPI in terms of upper extremity function, daily activities, sports, participation and overall quality of life. 2. To determine…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Obstetrisch Plexus Brachialis Letsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Socio-demographic status (age, gender, dexterity, education, work etc.),
relevant disease specific questions (not present in existing questionnaires)
regarding functional abilities, participation, the use of assistive devices,
cosmetics, impact on familiy, health care utilization and satisfaction with
care (OBPI GAP-C), Upper extremity functioning (ABILHAND-Kids, HUH, PODCI-NL,
DASH-DLV and MHOQ-DLV), Quality of Life (TAPQOL, TACQOL, TAAQOL, DISABKIDS,
SF-36), Physical Activity (SQUASH, AQUA), Participation (IPA, USER-P) and
Transition from childhood into adulthood (Rotterdam Transition Profile).
Secondary outcome
N.a.
Background summary
An Obstetric Brachial Plexus Injury (OBPI) occurs in about 0.4-4.6 per 100 live
births. Nerve damage to the brachial plexus can cause problems in using the
arm/hand even though primary and/or secondary surgery has been performed. Until
now little is known about perceived problems in daily life activities,
participation and quality of life in this patient group. The Leiden University
Medical Center (LUMC) is one of the 3 specialized OBPI centers in the
Netherlands and a large part of all patients with OBPI are or were seen here in
regard to their possible (functional) problems. This provides the opportunity
to gather more insight into the perceived problems of this patient group.
In regard to the health care usage and satisfaction about provided care, within
specialized centers as well as in local health care centers, in the OBPI
patient group knowledge is almost absent.
Study objective
The aim of the present study is:
Primary objectives:
1. To determine the health status of children and (young)adults with OBPI in
terms of upper extremity function, daily activities, sports, participation and
overall quality of life.
2. To determine health care usage and satisfaction with current health care in
patients with OBPI.
3. To investigate the relation between reported health status and the severity
and localization of the brachial plexus injury, taking into account received
medical treatment.
Secondary objectives:
4. To investigate the validity, reliability and usefulness of the Hand Use at
Home (HUH) questionnaire in the paediatric OBPI population (2-10 years old).
Study design
A cross sectional study will be performed by means of online or paper
questionnaires.
Patients and/or parents/legal representatives of patients will be asked to fill
out a number of questionnaires regarding the pre-mentioned domains once. To
investigate the validity and reliability of the HUH, the parents of patients
between the age of 2-10 years will be asked to fill out the HUH once again 2
weeks after the initial administration.
Study burden and risks
This cross sectional study will be carried out among children (0-16 years) and
(young)adults (>16 years) with an OBPI. All questionnaires will be filled out
by parents/legal representatives or patients where appropriate. The time to
complete all questionnaires is approximately 2 hours, except for the population
between the ages of 0-2 years in which it will be approximately 30 minutes, and
can be divided over different time points. The burden is minimal and no risks
are associated with participation in this study. The study gathers information
to gain more insight into health related Quality of Life, Arm function,
Activities and Participation of this patient group. In combination with the
information gathered about healthcare utilization and satisfaction of care this
provides valuable information to optimize care and patient information
regarding OBPI. Additionally a newly developed questionnaire (the Hand Use at
Home (HUH) questionnaire) is validated within the 2-10 year old patient group
which provides more insight into hand functioning. Such a questionnaire is not
available yet for the OBPI patient group.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Obstetric Brachial Plexus Injury
Exclusion criteria
Unable to read and write in Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48163.058.14 |