Forced use therapy in the piratsgroup to improve upper limb activities in children with Cerebral Palsy:
An approach in a meaningful setting with play-based occupational therapy

Title of the study:
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

Background of the study
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:
Forced 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 development of an attractive child centred intervention based on the forced
use perspective, to study the effects regarding the following question:

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.

1. RCT with a qualification period to evaluate the effectiveness of the
intervention
2. Cohort study to evaluate the achieved effect on a long-term period
3. exploring analyses to examine sub questions being not the primary question
in one of the above mentioned studies

Blinding:
There is blind rating of the tape recorded measurements. The raters are unaware
of the fact on which moment in the studyperiod the tape is made.
The measurement scores will be processed and analysed blindly.

Research set-up and planning:
An individual child is participating the research during 24 weeks ( first
follow-up included). Children in group Fc are participating longer: 32 weeks.

After a final selection áll participants will have the base measurement 1 to 10
(t0).
The children are beginning the so called control period (Co). Before and after
this 8 weeks period measurements take place (t0 en 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 as Fc, Fe, Sc or Se.

Explanation of abbreviations:
Co Control period (standard treatment 2x a week)
R Randomisation
C Control group
E Experimental group
Fe Failures experimental group (see page 10)
Fc Failures control group (see page 10)
Se Success experimental group: progression on AHA = 25% (see page 9
required number of children)
Sc Success control group: progression on AHA = 25% (see page 9 required
number of children)

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)

In the 8 weeks experimental period (E) the children are attending the Pirate
group for 3 hours during 3 afternoons 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 were now
bimanual play activities an 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 can*t 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 3hours of the *pirate afternoons* (3 times
a week ; Mondays, Tuesdays and Thursdays ) and during 6 weeks. They have 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. For two
afternoons the emphasis lays on improving strength and mobility, one afternoon
on fine motor skills.
To improve mobility the children with Zancolli IIb pattern will have to wear a
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.

Not applicable