Multi Sensory Stimulation And Priming (MuSSAP) in Infants at Risk of Unilateral Cerebral Palsy
Condition: Unilateral Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      A pilot randomized clinical trial exploring the effect of a Multi Sensory Stimulation And
      Priming (MuSSAP) training on improving manual ability in infants at risk of developing
      unilateral Cerebral Palsy.
    

Detailed description: 
      Rationale:

      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 contralateral
      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, 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. 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 or one arm and hand will be
      provoked. In contrast to the functional training focused primarily on motor output, MuSSAP
      enhances motor learning by stimulating the perception-action loop. 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.

      Objective:

      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 acceptability: Suitability of the intervention and the study procedures from
      the perspective of the participants. Determining effect sizes for a future full-scale
      randomized clinical trial and clinical relevance.

      Study design:

      The study is designed as a pilot randomized clinical trial (RCT) with three measuring moments
      (before intervention, after intervention, and follow-up).

      Study population:

      The study population consists of 16 infants at risk for developing unilateral cerebral palsy.
      These infants will either be born preterm suffering from unilateral periventricular
      haemorrhagic infarction, or born at term suffering from unilateral middle cerebral artery
      (MCA) stroke. The infants at risk will be allocated either to the MuSSAP intervention group
      (8 infants) or the Intensive Usual Care (Upper Limb) group (8 infants) by randomisation. Data
      of 8 typically developing infants will be used to monitor typical development of infants of
      4-12 months old.

      Intervention:

      Both the MuSSAP and the Intensive Usual Care (Upper Limb) interventions are home based and
      consist 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 and holding 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.

      Multi Sensory Stimulation And Priming (MuSSAP): In the MuSSAP intervention a custom made
      wristband will be used to provide rhythmical congruent multisensory stimulations to the
      affected arm and hand aiming to increase attention for the affected upper limb. Subsequently,
      motor actions of the affected arm and hand will be provoked.

      Intensive Usual Care (Upper Limb): This 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.

      In both intervention groups infants will additionally receive pediatric physical therapy in
      the home environment (usual care) focusing on gross motor development.

      Primary study parameters/outcome of the study:

      The primary study parameter aims at development of handfunction/ manual ability (measured
      with the Hand Assessment for Infants (HAI)).
    

Intervention name(s): Multi Sensory Stimulation and Priming; Intensive Usual Care (Upper Limb)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In the MuSSAP intervention group, the infant wears a multisensory stimulating wristband aiming at increasing attention for the affected upper limb and readiness to initiate a goal-directed movement. Parents are instructed to present a toy to their child if the child shows attention to the affected arm and hand. Upper extremity motor activities like reaching, grasping and holding are practiced. Parents practice daily and once a week the training will be guided or conducted by a physical or occupational therapist in the home environment. An occupational therapist from the rehabilitation center will coach parents during the intervention period through the internet, by means of analyzing the videos from the home training.; 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. Upper extremity motor activities like reaching, grasping and holding are practiced. Parents practice daily and once a week the training will be guided or conducted by a physical or occupational therapist in the home environment. An occupational therapist from the rehabilitation center will coach parents during the intervention period through the internet, by means of analyzing the videos from the home training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Multisensory Stimulation; Hand function; Infants; Early intervention