Do Core Stability Exercise Classes Help Children With Cerebral Palsy Improve Their Balance
Do Core Stability Exercise Classes Help Children With Cerebral Palsy Improve Their Balance
This study aims to determine if participation in a core stability physiotherapy group
 programme can improve the balance of children with cerebral palsy. It is hypothesised that
 teaching the children how and when to activate their deep core stabilising muscles may help
 improve their body awareness and their ability to control their alignment and therefore
 positively affect their balance. Children with cerebral palsy from the ages of 7 to 17, who
 can walk independently, will be randomly selected to join either the control group or
 intervention group, after completion of their baseline balance assessments. Each group will
 be re-assessed after completion of their 4 week intervention or control period.
Introduction

 The 'Core Muscles' are defined as '29 pairs of muscles that support the lumbo-pelvic hip
 complex in order to stabilize the spine, pelvis and kinetic chain during functional
 movement'.

 Core stability refers to the control, co-ordination and synergism required by the core
 muscles for the maintenance of functional stability and balance. The role the core
 musculature plays in movement and postural control is long established. The understanding
 that our core muscles work in a feed-forward manner, laying the foundation of distal limb
 movement, formed the basis for studies into the use of core stability training programmes,
 such as pilates, core control training and spinal stability training, for improved postural
 control and balance.

 Literature is replete with studies investigating the use of core stability programmes for
 varied populations from the adult population for chronic back pain to elite athletes for
 injury prevention and performance.

 Studies investigating its use in adults with postural control impairment due to upper motor
 neuron lesions (UMN) from Multiple Sclerosis and Stroke showed positive effects on balance
 and mobility. The randomised controlled trial, by Chung et al, looked at the effects of a 4
 week core stability exercise class on Dynamic Balance and Gait Function of 16 stroke
 patients. It showed a significant improvement of Timed-Up-And-Go (TUG) scores from 33.06
 +-18.39sec to 27.64+- 13.73 sec (p=0.057) in the intervention group. Gait velocity (from
 44.83+- 18.83 cm/s to 58.91 +- 18.21 ; p=0.024) and cadence ( from 74.55+- 13.85 steps/min to
 84.07 +- 14.00 steps/min ; p=0.041) also showed significant improvement in the intervention
 group. To date there are no studies investigating the use or potential benefit of specific
 core stability intervention in the Cerebral Palsy (CP) population.

 CP describes a group of permanent disorders of the development of movement and posture,
 causing activity limitation, that are attributed to non- progressive disturbances that
 occurred in the developing fetal or infant brain. It has been suggested that poor postural
 control may underlie delays and deviations in motor skill acquisition and development
 observed in children with CP. Therefore, it is important that treatment of children with CP
 tries to improve postural control and the evidence suggesting postural control mechanisms in
 school-age children with CP are modifiable signifies that this goal is achievable.

 Young children with CP have been shown to use excessive, non-reciprocal trunk and hip muscle
 activation during walking. It has been hypothesized that one reason for this may be their
 need to compensate for poor control of their core deep stabilising muscles, thus limiting
 their ability to control changes in their body's centre of mass (COM) during dynamic
 movements. To understand this further we must look closer at the different functions of the
 core muscles.

 The core muscles can be separated into large-lever, superficial global muscles, including the
 rectus abdominis and psoas major, that function as primary movers and smaller, deep, local
 muscles, including the Transverse Abdominis and Internal oblique, that function as primary
 stabilisers. It is postulated that if the deep stabilisers are not adequately functioning,
 then postural control is assisted by secondary compensatory activation of other muscles that
 typically function as primary movers like the hip flexors, knee flexors and spinal extensors.
 When a primary mover is being used to compensate for deep stabilisers, it becomes less
 efficient in its role in mobilizing and posturally adjusting.

 An ineffective deep stabilizing system also limits the ability of the body to maintain the
 joints in a position where muscles are at a mechanical advantage. This can have an added
 'weakening' effect on muscles that are essential for postural control, like the gluteus
 medius, as it reduces their force-generating capacity.

 The objectives of the study are:

 1. To measure changes in performance on a series of static, anticipatory and reactive
 balance tasks using three dimensional motion analysis in children who participate in
 core stability (intervention group) compared to children who continue their usual care
 (control group).

 2. To compare changes in functional balance tests of the intervention group to the control
 group

 3. To analyse qualitative data from a post intervention questionnaire to determine the
 broader effects of the 'Core stability' group intervention on the child's real life
 function, participation and quality of life.

 Selection Criteria

 The study aims to investigate the effects of a treatment intervention on children with
 Cerebral Palsy (CP). It is best research practice to choose a homogenous group of
 participants for meaningful results. It has been shown that in relation to balance of
 ambulatory children with spastic CP, a functional classification system (Gross motor Function
 Classification System-GMFCS level) can be used to group children more homogenously than
 traditional classification by diagnosis. On this basis, it was decided to include children
 with GMFCS levels I and II. Ambulatory children with a GMFCS classification level III were
 excluded as most studies showed a large gap in balance abilities between levels II to III.
 This would lead to a much greater variance in the participant sample.The Central Remedial
 Clinic (CRC) database of clients attending Clondalkin or Clontarf physiotherapy services will
 be used to generate a list of clients aged 7 to 17, with spastic CP diplegia or hemiplegia
 GMFCs level I or II for each centre.

 The study inclusion/exclusion criteria will then be applied to this list. The clients not
 meeting the inclusion criteria or those meeting the exclusion criteria will be removed. The
 remaining clients will be invited to participate in the study and a list will be generated of
 participants who agree.

 The resulting list will be split into 2 separate age groups (Age 7-12 years and Age 13-17
 years) and unique identifying numbers will be assigned to each client on the day of their
 initial baseline assessment.

 The clients will be assessed in groups of a minimum of 6 and maximum of 12 and will be
 randomised according to the procedure detailed below.

 Sample Size

 The sample size was calculated in Stata IC 13 (StataCorp, Texas, USA) using step length as
 the primary outcome measure. A previous study comparing gait in CP and typically developing
 children over level and uneven ground found a mean difference of 9cm (standard deviation 9cm)
 in step length between groups (Malone et al 2014, submitted for publication). With a power of
 0.9 and significance level of 0.05, a sample size of 22 in each group was derived, giving a
 total of 44. To allow for a 10% drop out, it was decided to enroll 48 participants to the
 study.

 Randomisation

 A randomisation procedure will be carried out by an individual blinded to both the treatment
 and assessment procedure. The unique identifying number of the individual and their group
 will be in-putted into an electronic randomisation tool. Group assignment will be known to
 the treating therapists but not to the assessing therapist to ensure a single-blind design.

 The participants will be allocated based on randomisation to either Intervention (I) or
 control (C).

 Statistical analysis

 The primary research question is whether core stability classes improve movement and function
 in the intervention group (I) compared to the control group (C). Data will be plotted
 graphically and described in the first instance using means, medians, standard deviations.
 Normality will be assessed using the Shapiro Wilk test. Groups will be inspected for baseline
 comparability. Quantitative parametric data from movement analysis assessment will be
 compared for (I) and (C) groups using analysis of co-variance including baseline levels of
 the outcome and adjusting for any baseline imbalances. Non-normally distributed data, e.g.
 Functional Walk Test, will be compared using Poisson regression.

 Statistical analysis will be performed with Stata IC 13. Statistical assistance will be
 available from the Department of Epidemiology in RCSI.

 Ethical Approval

 Ethical approval has been obtained from the CRC Ethics committee

 Informed Consent A written explanation of the study and core control group will be provided
 for the parent/guardian and participant. The information will be presented in a manner that
 is easy to understand and outline the risks and benefits of the study clearly. Each parent
 and participant will be given the opportunity to ask questions in writing or verbally and the
 parent/guardian will then sign a consent form. Refusal to participate in the study will not
 affect the client's general physiotherapy care from the CRC in any way.

 Participants The control group will not work on focused balance specific core stability work
 in physiotherapy over the four-week control period. They will receive all other usual
 physiotherapy care during this period. Participants who are initially assigned to the control
 group will then be offered to participate in a Core Stability group after the control period
 assessments are completed. Therefore, all study participants (intervention and Control
 groups) will be given the opportunity to avail of the 'Core Stability' physiotherapy group
 programme. Each group will have to attend the same number of assessments (1 pre assessment
 and 1 post assessment)

 Data Collection and Protection All data collected from the study will be restricted to the
 circumstances listed on the signed consent form. The procedures in place in relation to data
 storage and processing in the Gait Laboratory and the Physiotherapy Department in the CRC
 will be followed. Identifying information will only be stored in the CRC secure server.

 Potential Risks During the Balance assessment in the gait laboratory, markers will be placed
 on the skin with adhesive tape. Taking these off may cause very slight discomfort. To
 alleviate this adhesive removal spray can be used.

 The gait lab balance assessment is designed to be a measure of dynamic balance. Therefore,
 participants will be asked to do some tasks that may be challenging to them. They will be
 supervised at all times when carrying out the assessment by the independent assessor. Stand
 by assistance will be provided if required for safety.

 The 'Core Stability' physiotherapy group intervention programme may be both mentally and
 physically challenging for the participants. It will involve concentration and repetition of
 activities. The group will be carried out under the supervision of two paediatric senior
 physiotherapists who work regularly with this CP population. These physiotherapists will have
 a strong knowledge base of this population's physical limitations. They are also experienced
 in how to encourage and motivate paediatric clients to carry out challenging activities.
Inclusion Criteria:

 -  Children with spastic Cerebral Palsy (CP)

 -  Ages 7 - 17 (inclusive)

 -  GMFCS I-II (Gross Motor Function Classification System)

 -  Diplegia, Hemiplegia

 -  Balance problems identified (Determined by primary PT's treating problem list and/or
 score on balance assessments in use)

 -  Parental Informed Consent

 -  Can follow verbal instructions and willing to participate in a group intervention
 setting

 Exclusion Criteria:

 -  Recent surgery to lower limbs (within past year)

 -  Botulinum Toxin (BTX-A) or serial casting to lower limbs within the last 3 months (or
 planned for during intervention or control period)

 -  Completed a core stability training group within the previous year

 -  Neurological or orthopaedic conditions unrelated to CP

 -  Behavioural difficulties limiting ability to participate in groups

 -  Intellectual difficulty that would make it difficult to comprehend and cooperate with
 treatment and/or testing