|- candidate number||4551|
|- NTR Number||NTR1546|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-nov-2008|
|- Secondary IDs||CMO nr. 2006/194 MEC: Commissie Mensgebonden Onderzoek Regio Arnhem/Nijmegen |
|- Public Title||Forced Use in the Pirate group for children with predominant unilateral Cerebral Palsy.|
|- Scientific Title||Is a period of 6 weeks Forced Use of the more affected upper limb (I) for children with Cerebral Palsy and asymmetric upper extremities, combined with two weeks bimanual play activities in the so called Pirate group (for 3 hours on 3 afternoons a week) providing the opportunity to increase (O) the spontaneous use qualitatively and quantitatively more than a standard group therapy with the same duration and frequency but without using “forced use” (C).
Using PICO systematic P stands for patient, I for intervention, C for comparison and O for outcome.
|- ACRONYM||Effect study: forced use therapy based on play combined with intensive occupational therapy in the so called pirate group to improve the skills of arm/hand in children with cerebral palsy and asymmetric upper limbs.|
|- hypothesis||A period of 6 weeks Forced Use of the more affected upper limb for children with Cerebral Palsy and asymmetric upper extremities, combined with two weeks bimanual play activities in the so called Pirate group (for 3 hours on 3 afternoons a week) will provide the opportunity to increase the spontaneous use qualitatively and quantitatively more than a standard group therapy with the same duration and frequency but without using “forced use”.
|- Healt Condition(s) or Problem(s) studied||Cerebral palsy, Children|
|- Inclusion criteria||1. Age: 2 to maximal 8 years old. |
2. Cerebral Palsy with spastic hemi pareses of asymmetric tetra pareses.
3. Mentally development on a level that simple tasks can be understood and executed (developmental age minimal 2 years).
4. Possibility to combine the intensive group program (3 afternoons weekly) with an existing school program (developmental age maximal 6-7 years).
5. Child must be able to walk independent and without walking aid.
6. The more affected upper limb is used less then can be expected based on motorical possibilities (developmental disregard).
|- Exclusion criteria||1. Presence of behavioural characteristics in such extent that parents and/or rehabilitation physician in chard judge the intensity of the group programma (3 afternoons a week) is too much to sustain for the child.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||2-jan-2007|
|- planned closingdate||20-apr-2009|
|- Target number of participants||36|
|- Interventions||In the 8 weeks experimental period (E) the children are attending the Pirate group for 3 hours during 3 afterenoons a week to be treated according to the Forced Use (FU) principles.|
After 6 weeks the FU therapy stops.
The following 2 weeks the children will be attending the Pirate group where now bimanual play activities and ADL are presented according to a protocol.
After this period of 8 weeks the Pirate program is completed and next measurement will take place (t3). After every therapy meeting a registration form will be filled in for every child to record what activities have been done (E/C group).
Protocol Forced Use Therapy (first 6 weeks):
A sling will be individually made for every child before the Pirate group starts. A sling is a cloth in which the not affected arm rests in such manner that the arm, hand, fingers and thumb cannot be used. The children are told that they are pirates and their good arm is injured so it has to stay in the “bandage” (sling).
The sling will be put on during the 3 hours of the “pirate afternoons” (3 times a week: Mondays, Tuesdays and Thursdays) and during 6 weeks. It has to stay on the full afternoon.
Parents are provided with suggestions to stimulate the use of the affected arm/hand at home in bimanual activities. The responsible therapist will use E-learning for these instructions/suggestions.
The Pirate group activities are recorded in the Pirate Handbook.
To improve mibility the children with Zancolli IIb pattern will have to wear an ortheses at day-time (an individually made cock-up splint consisting of low temperature thermo plastic material (LTTP) (Verreussel, 2004).
The ortheses, if not yet provided, has to be manufactured before the start of the study.
In the control group the children will be stimulated during at least 9 hours a week to use both hands in bimanual activities. These hours will be registrated in a child-friendly system. These children have conventional occupational and physical therapy during one hour a week.
|- Primary outcome||Measurement 1: AHA|
AHA, Assisting Hand Assessment, has been developed for children aged 18 months to 6 years with a unilateral disorder at the hand/arm due to Cerebral Palsy of Obstetric Plexus Brachial Leasion.
Measurement 2: ABILHAND-Kids
The ABILHAND-Kids is a questionnaire to measure manual ability. Parents are asked to fill in the questionnaire.
|- Secondary outcome||Measurement 3: Melbourne|
The “Melbourne Assessment of unilateral upper limb function for children with neurological impairment”.
Measurement 4: COPM and GAS
COPM is an instrument to list the experienced problems in daily living by means of an open interview.
Subsequently goals are described in steps by means of Goal Attainment Scaling (GAS) to make the results measurable.
Measurement 5: VOAA
Observation of the use of the affected arm and hand during bimanual activities. The Video Observation Aarts & Aarts will be used to measure duration and frequency.
Measurement 6: Mobility ROM
Active and passive ROM (Range of Motion) of wrist (with fisted hand and also with extended fingers), elbow and Thumb are determined by means of a goniometer.
|- Timepoints||The children are beginning the so called control period (Co). Before and after this 8 weeks period measurements take place (t0 and t1). |
Subsequently by randomisation the children will be divided in the experimental group (E) and the control group (C).
Dependent on the effect of the interventions children will go on als Fc, Fe, Sc or Se.
Explanation of abbreviations:
Co=Control period (standard treatment 2x a week)
Fe=Failures experimental group
Fc =Failures control group
Se=Success experimental group
Sc=Success control group
- t0 – t6 is time 0 to 6
- t0 to t1 = 8 weeks (control period)
- t1 to t2 = 8 weeks (intervention)
- t2 to t3 = 8 weeks (intervention for Fc, first follow-up for Fe, Se and Sc)
- t3 to t4 = 8 weeks (1st follow-up for Fc after which intervention will follow)
- t4 to t5 = 16 weeks (2nd follow-up for Fe, Se and Sc)
- t5 to t6 = 16 weeks (2nd follow-up for Fc after which intervention will follow)
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| P.B.M. Aarts|
|- CONTACT for SCIENTIFIC QUERIES|| P.H. Jongerius|
|- Sponsor/Initiator ||Sint Maartenskliniek Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief summary||STUDY Forced Use in the Pirate group for children with predominant unilateral Cerebral Palsy:|
RCT with a qualification period to evaluate the efectiveness of the intervention
Cohort study to evaluate the achieved effect on a long-term period
Exploring analyses to examine sub questions being vot the primary question in one of the above mentioned studies.
Interventions aimed at arm/hand skills with children with a spastic pareses are expected to influence positioning and manipulation in order to improve manual skills. Therapy, based on the perspective of “forced use of the affected upper limb” is known under different names, namely:
Force Use (FU)
Constraint Induced Movement Therapy (CI or CIMT)
Modified Constraint Induced Movement Therapy (MCIT)
Point of similarity is that, by wearing a sling, glove or ortheses on the únaffected arm, one is forced to use the affected upper limb. The intensity is varying from two to eight hours a day during two to eight weeks.
The aim of this study is the development of an attractive child centred intervention based on the forced use perspective, to study the effects regarding the hypothesis.
|- Main changes (audit trail)|
|- RECORD||19-nov-2008 - 28-nov-2008|