|- candidate number||9412|
|- NTR Number||NTR2884|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-mei-2011|
|- Secondary IDs||11-N-18 METC Heerlen|
|- Public Title||The influence of physiotherapy on the shoulder function of children with Obstetric Brachial Plexus Injury (OBPL).|
|- Scientific Title||The influence of physiotherapy on the shoulder function of children with Obstetric Brachial Plexus Injury (OBPL).|
|- ACRONYM||OBPL, Erb's palsy|
|- hypothesis||The expectation is that children with OBPL who received more physiotherapy have a better shoulder function than children with OBPL with less received physiotherapy. |
|- Healt Condition(s) or Problem(s) studied||Children, Shoulder function, Obstetric brachial plexus injury, Erb's palsy|
|- Inclusion criteria||1. Children with OBPL who have C5-6 or C5-C6-C7 lesions;|
2. Age group: 1994-2006;
3. Children which received this lesion at birth;
4. Children with OBPL from the Netherlands and Belgium.
|- Exclusion criteria||1. Children with OBPL which also have C8 and/or Th1 lesions besides above mentioned lesions;|
2. Low level of development. The child should be able to understand and execute the instructions;
3. The parents of the children younger than 12 years old have to understand the Dutch language.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-mei-2011|
|- planned closingdate||31-dec-2011|
|- Target number of participants||100|
|- Interventions||Classification of two groups:|
1. High frequent physiotherapy group:
Children with OBPL who received weekly ≥60 minutes of physiotherapy during their life;
2. Low frequent physiotherapie group:
Children with OBPL who received weekly <60 minutes of phsyiotherapy during their life.
|- Primary outcome||Results on functional level of the shoulder:|
1. Mallet Score (active shoulder function): 5 items (scores: II-IV);
2. Range of Motion (ROM, passive shoulder function): 7 items (degrees).
Results on activity level of the shoulder:
1. ABILHAND-children: 21 items (scores: impossible, difficult, easy).
|- Secondary outcome||Same as the primary. The only difference is that the execution of shoulder related sports is included as physiotherapy minutes. The distribution of the participants in the above mentioned groups will change and probably also the outcomes.
The classification of the two groups will be the same. |
|- Timepoints||One measure moment at present for the Mallet score, the ROM and the ABILHAND-Kids.|
Previously measured ROM and Mallet scores.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Y.J.M. Janssen-Potten|
|- CONTACT for SCIENTIFIC QUERIES||Drs. N. Haga|
|- Sponsor/Initiator ||Atrium Medical Center, Heerlen|
(Source(s) of Monetary or Material Support)
|Stichting ter Behartiging der Belangen van het Gebrekkige Kind, Valkenburg|
|- Brief summary||A cross-sectional study will be executed by which a group children with OBPL who received frequently physiotherapy will be compared with a group of children with OBPL who received less frequent physiotherapy. |
The results of both groups will be compared on shoulder mobility, arm-hand function and arm-hand ability.
The frequency and duration of the physiotherapy, the executed sports and measured Mallet scores in the past will be collected by retrospective research.
Both Belgium and Dutch children with OBPL are invited. Belgium children receive in general more often physiotherapy than Dutch children. For reaching sufficient participants in both classification groups it is important to have participants with much and less physiotherapy.
|- Main changes (audit trail)|
|- RECORD||4-mei-2011 - 12-mei-2011|