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

NCT03888508 | Completed DMC

• 1 other identifier: SIT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Mean change in GMFM-88 Score from baseline

  Gross Motor Function Measure (GMFM-88) The gross motor function measure-88 (GMFM-88) is a well-known scoring system, which assesses gross motor development in children with CP over time in 5 domains A (lying and rolling), 17 items B (sitting), 20 items C (crawling and kneeling), 14 items D (standing), 13 items; E (walking, running, and jumping), 24 items.

  3 months

Secondary Outcomes (3)

• Mean T score change from baseline in CBCL

  3 months

• Mean score change from baseline in Pediatric quality of life scale from baseline

  3 months

• Mean score change from baseline in parent rated 10 item Likert scale

  3 months

Study Arms (2)

SIT plus standard therapy

EXPERIMENTAL

Sensory interventions will include maneuvers for both hypo and hyper-reactive behaviors in five senses such as tactile, vestibular, proprioception, vision and auditory using a sensory integration kit and other items available at home Sensory integration kit will be prepared which consists of varying textures from soft to hard items (wool, jute, sand paper, velvet), picture cards, sensory brush, elastic band(Thera tube) and also usage of other home based items such as swings, sofa/bed, textured board, black board, wet chalks and paint. Each session would take approx 60 minutes/ day with each sensory stimulus given for 10-30 minutes 6 d Conventional physiotherapy, occupational,behavioural intervention and pharmacotherapy that they are already receiving as a standard therapy

Other: SIT

Standard therapy alone

NO INTERVENTION

Standard therapy -Conventional physiotherapy, occupational,behavioural intervention and pharmacotherapy that they are already receiving

Interventions

SIT OTHER

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.

Also known as: Standard therapy

SIT plus standard therapy

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All india institute of Medical sciences

Delhi, South Delhi, 110029, India

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sheffali Gulati, M.D

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief,Child Neurology Division,

Model Details: Single Blind Randomized Controlled Parallel Design trial

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: March 25, 2019
• Study Start: July 25, 2018
• Primary Completion: August 16, 2019
• Study Completion: August 16, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)