Comparison of Efficacy of Sensory Integration Therapy in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      In this we are comparing efficacy of sensory integration therapy as an adjunct to standard
      care with standard care alone in improving gross motor skills in cerebral palsy children with
      sensory processing abnormalities.Existing literature points towards presence of sensory
      processing abnormalities in children with cerebral palsy.However, there is lack of robust
      evidence for usefulness of sensory integration therapy in cerebral palsy children .Standard
      therapy outcome in improving functional motor skills, adaptive responses are variable in
      children with cerebral palsy.Sensory integration therapy in addition to standard therapy may
      further improve adaptive and functional motor skills in children with cerebral palsy.
    

Detailed description: 
      -  Study will be started after obtaining ethical clearance and registration with Clinical
           trials registry of India

        -  Hindi translation of SPCQ-2(Sensory profile caregiver questionnaire 2) by subject expert
           by forward and independent backward translation .

        -  Consecutive children of either sexes between 3-12 years with a clinical diagnosis of
           spastic cerebral palsy will be examined by the investigator and those having sensory
           abnormalities as screened by Sensory profile caregiver questionnaire 2 will be included
           in the study group.

        -  Those children who screen positive for sensory abnormalities fulfilling the inclusion
           criteria would be enrolled in the study after obtaining informed consent from the
           parents or guardian.

        -  Once enrolled children would be randomized into 2 groups , using a computer generated
           random number sequence, an interventional group receiving sensory integration therapy
           along with standard therapy and a group receiving standard therapy alone.

        -  Concealment of the random allocation would be ensured by placing the allocation sequence
           in serially numbered, tamper proof, opaque and sealed envelopes(by a person other than
           primary investigator to ensure blinding and further observation bias)

        -  Post - enrollment - Baseline clinical and demographic data will be recorded along with
           associated co morbidities (maladaptive behavior, sensory deficits and motor problems).

        -  Pre-intervention a baseline motor skill will be obtained using Gross Motor Function
           Measure -88 and behavioral assessment would be done using Child Behaviour Checklist
           within 7 days of starting therapy in both arms (by pediatric neurologist ,child
           psychologist respectively and who is unaware of the randomization and allocation to both
           arms to prevent observer bias).

        -  Pre-intervention investigator would also interact with the parents or the primary care
           giver and record parent's assessment of severity of sensory abnormalities in 5 main
           domains - auditory , visual, tactile, proprioceptive and vestibular senses on a 10 item
           Likert scale and also assess Quality of life using Pediatric Quality of life using
           Pediatric Quality of life scale

        -  All children would be followed at set intervals from initiation of therapy as noted
           below ;

        -  Weekly for 2 weeks then fortnightly for next 10 weeks to ensure proper technique and
           compliance.

        -  At 3 months the blinded outcome assessor and child psychologist will re evaluate the
           enrolled candidate to determine for any change by using Gross Motor Function Measure -88
           , 10 item parent rated Likert scale, Child Behaviour Checklist and Pediatric Quality of
           life as compared to baseline within 7 days of completion of therapy in both arms

      The first visit would be primarily aimed at reinforcing the techniques of therapy and
      clarifying parent's doubts. At 3 month visit child would be evaluated and re-assessed using
      the scores- 10 item Likert scale rated by parents, Gross Motor Function Measure -88 and
      Pediatric Quality of life scale . Parents would be encouraged to bring one random home video
      of child doing activity-based therapy at 2 weeks wherever feasible . The video would be used
      for ,

        -  Assessing the correct technique

        -  Suggesting modifications in the activity schedule if required

        -  Helps in ensuring adherence to technique

      Compliance would be ensured by the

        -  Activity log

        -  Telephonic re-enforcement from the primary investigator weekly
    

Intervention name(s): SIT
Intervention type(s): Other
Intervention description(s): sensory integration therapy along with standard therapy.
Primary care giver will be trained to perform sensory integration therapy at home.
. Sensory interventions will include maneuvers for both hypo and hyper-reactive behaviors in five senses as tactile, vestibular, proprioception, vision and auditory using a sensory integration kit and other items available at home
Daily sessions of approx 60 minutes/ day with each sensory stimulus given for 10-30 minutes 6 days in a week will be done.
Other intervention name(s): Standard therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single Blind Randomized Controlled Parallel Design trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment