Multi Sensory Stimulation And Priming (MuSSAP) in infants (4-12 months of age) at risk of developing Unilateral Cerebral Palsy (UCP).

Unilateral Cerebral Palsy (uCP) results from early brain damage. In adults,
brain damage in one side of the (pre) motor cortex is associated with
functional problems in the contralateral side of the body and vice versa. This
is related to extensive crossings of the descending corticospinal tracts
connecting the central motor systems with the musculature of the extremities.
However, during the first years of our lives, crossings of the corticospinal
tracts are less defined and the motor system relies on both ipsi- and
contra-lateral connections to control the extremities. In children with uCP the
classical development and strengthening of the crossed connections of the
corticospinal tracts might be hampered. Although reorganization with
ipsilateral corticospinal tracts can mediate useful hand function or
near-to-normal hand function, patients with the most favourable functional
outcome retain crossed projections from the affected hemisphere.
To facilitate maturation of the corticospinal tracts, it seems crucial to start
early with intervention at the stage that the corticospinal tracts show high
plasticity.
In this study, we propose to pilot test whether a new intervention; Multi
Sensory Stimulation And Priming (MuSSAP) can be applied in clinical practice in
infants 4-12 months of age with diagnosed unilateral cerebral damage having
increased risk on the development of unilateral cerebral palsy. In the MuSSAP
training both arms and hands will be stimulated when no clinical signs of an
asymmetry in upper extremity motor functioning is visible.
With no clear asymmetric development of arm and hand function there could be a
risk for the potentially preferred hand lagging behind in motor development
when only the potentially affected arm and hand would be stimulated. However,
when there are clear clinical signs for already existing asymmetry in upper
extremity function, the intervention will focus on the less functioning arm and
hand.
The arm and hand will be stimulated in a multisensory rhythmically synchronous
way. In the meanwhile attention benefits from multisensory congruent signals,
particularly if this congruency involves rhythmical similarity. Attention
influences the sensitivity of neurons to detect sensory activity and the
ability of neurons to detect sensory stimulation. Formation of neural pathways
is facilitated by increasing activity in (new) functional neural circuits.
During the multisensory stimulation, motor actions of both arms and hands will
be provoked. In contrast to the primary focus on motor skill acquisition in
functional training, Multi Sensory Stimulation And Priming (MuSSAP) aims to
enhance motor learning by stimulating the perception-action loop, thus
improving binding within neural circuits involved in the early developmental
stages of establishing goal-directed movements.

Primary objective:
The following hypothesis will be tested:
MuSSAP in infants 4-12 months of age with diagnosed unilateral cerebral damage,
is a feasible protocol and results in an enhanced motor development as compared
to Intensive Usual Care (Upper Limb).Secondary Objective(s):
* Assessment of feasibility of the intervention:
Can the MuSSAP intervention and procedures be successfully executed and
delivered to the participants?
* Assessment of feasibility of the study design and procedures:
Scrutinizing inclusion and exclusion criteria, recruitment feasibility,
scrutinizing the appropriateness of the outcome measures
* Assessment of acceptability:
Suitability of the intervention and the study procedures from the perspective
of the participants
* Determining effect sizes for a future full-scale RCT and clinical relevance:
specific hypothesis to be tested:
o Infants at risk for uCP in the MuSSAP intervention group will show a trend to
higher scores on the outcome measures on three moments in time (T0, T1, T2)
then infants at risk for uCP in the Intensive Usual Care intervention group.
o Typically developing infants will show a trend to higher scores on the
outcome measures on three moments in time (T0, T1, T2) then infants at risk for
uCP.

Design:
The study design is a pilot case- control study with three measuring moments,
T0, T1, T2.

MuSSAP
In contrast to the primary focus on motor skill acquisition in functional
training, Multi Sensory Stimulation And Priming (MuSSAP) aims to enhance motor
learning by stimulating the perception-action loop. By presenting the infant
simultaneous, rhythmic visual, auditory and tactile input, we aim to increase
attention and to compensate diminished activations in the perception-action
loop, thus improving binding within neural circuits involved in the early
developmental stages of establishing goal-directed movements.
In the MuSSAP training both arms and hands will be stimulated when no clinical
signs of an asymmetry in upper extremity motor functioning is visible.
With no clear asymmetric development of arm and hand function there could be a
risk for the potentially preferred hand lagging behind in motor development
when only the potentially affected arm and hand would be stimulated. However,
when there are clear clinical signs for already existing asymmetry in upper
extremity function, the intervention will focus on the less functioning arm and
hand.
In the MuSSAP intervention custom made therapy material will be used to provide
rhythmical congruent multisensory stimulations to both arms of the infants.
During the multisensory stimulation, motor actions of the arm and hand will be
provoked. The MuSSAP intervention consists of 30 minutes (divided in 3 periods
of 10 minutes each) of stimulation each day for an 8-week period, conducted by
the parents in the home environment. Once a week a physical or occupational
therapist from a therapy practice in the neighbourhood of the infant, will
provide the intervention to the infant and will give instruction and tips to
the parents on how to stimulate their child following the principals of the
MuSSAP intervention.
Coaching of parents and therapists will be performed by the occupational
therapist of the Sint Maartenskliniek. This will be realised through analysing
video recordings of the intervention in the home environment once a week.

Intensive Usual Care (Upper Limb)
The Intensive Usual Care (Upper Limb) intervention is a more intensive (in
duration and frequency) version of standard Usual Care with focus on the motor
development of the affected upper extremity. This intervention consists of 30
minutes (divided in 3 periods of 10 minutes each) of remediating impairments
practicing specific age related movements and skills, each day for an 8-week
period, conducted by the parents and once a week by a physical or occupational
therapist in the home environment. Upper extremity motor activities like
reaching, grasping, pulling and taking support are practiced. Coaching of
parents and therapists will be performed by the occupational therapist of the
Sint Maartenskliniek. This will be realised through analysing video recordings
of the intervention in the home environment once a week.


Co-intervention
In both intervention groups infants will additionally receive pediatric
physical therapy in the home environment (usual care). Therapists identify the
impairments underlying a functional limitation (e.g. tone, posture, range of
motion), and provide therapy to remediate the impairments practicing specific
age related gross motor movements and skills. Functional mobility activities
like rolling, crawling, standing and walking are practiced and also stretching
of muscles will be part of the intervention. Parents will receive information
about eating, drinking, sleeping positioning, seating positioning etc.

The burden the participants will experience exists of the measurements that
will be done at three moments (T0, T1, T2) in the study, and of the
intervention itself. Measurements will be conducted in the home environment of
the participants. The measurements can be performed in a trusted environment
for the infants and therefore the burden will be as low as possible. There are
no risks involved in all the measurements and the intervention.
At all times the comfort of the participant will be taken into account. *
Parents will be asked to fill out a questionnaire at T0, T1 and T2. At T2
parents will be interviewed about the experiences with the intervention.
During the intervention period parents have to video record the intervention on
a daily basis and will be asked to fill out a registration form about what has
been practiced in the intervention session.