Comparison of Efficacy of Sensory Integration Therapy in Children With Cerebral Palsy

• 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

Inclusion criteria

• Children of either sex aged 3 to 12 years clinically diagnosed to have spastic cerebral palsy

• Definite Sensory processing abnormality defined as (more than 2 standard deviations below the mean) in at least one of the nine domains of sensory profile -2 questionnaires
• GMFCS either I, II or III
• Minimum visual acuity of 6/60
• IQ/SQ>70.
• Either parent should be willing to come for follow up.
• Stable pharmacotherapy, conventional physiotherapy, behavioral interventional therapy and occupational therapy for last 4 weeks

Exclusion criteria

• Receiving /received Sensory Integration therapy in the past 6 months
• Hemi paretic and mixed cerebral palsy
• Children of either sex aged 3 to 12 years clinically diagnosed to have spastic cerebral palsy

• Fixed contractures and deformities in lower limbs affecting stance and gait.
• Received botulinum toxin injection or undergone orthopedic corrective surgery in the past one year prior to enrolment
• Refractory epilepsy as per ILAE definition.
• Failure of adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules (whether as mono therapies or in combination) to achieve sustained seizure freedom

• Autistic features, Attention Deficit Hyperactivity Disorder, Specific Learning Disability satisfying Diagnostic and Statisitical Manual of Mental disorders V criteria for these disorders
• Current clinically significant medical disorders (as determined by Investigator)
• Cardiovascular (e.g. Congestive Cardiac Failure)
• Respiratory (e.g. severe asthma, severe pneumonia)
• Gastrointestinal (e.g. upper GI bleed)
• Renal (e.g. acute renal failure )
• Hepatic (e.g. acute liver failure)
• Hematologic or other medical disorders