Cerebral Palsy Clinical Trial
Official title:
Comparison of 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
NCT number | NCT03888508 |
Other study ID # | SIT |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 25, 2018 |
Est. completion date | August 16, 2019 |
Verified date | November 2019 |
Source | All India Institute of Medical Sciences, New Delhi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 16, 2019 |
Est. primary completion date | August 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 12 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
India | All india institute of Medical sciences | Delhi | South Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Mean T score change from baseline in CBCL | Child behaviour checklist (CBCL)-140 items-Self-administered or administered through an interview; norm referenced comprehensive measure of behavior; examines aggression, hyperactivity, bullying, conduct problems, defiance, violence Three formats: Teacher Report Forms, Youth Self-Reports, and Direct Observation Forms Yields standard scores: Total Competence, Total Problems, Internalizing, Externalizing, Attention Problems | 3 months | |
Secondary | Mean score change from baseline in Pediatric quality of life scale from baseline | PedsQL-The PedsQL measurement model is a modular approach to measure health related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL measurement model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. It's a brief 23 item multi-dimensional scale, comprising questions in physical, emotional, social and school functioning sectors. Takes around 4 minutes to administer the scale. Has both self-report and proxy report for the children for various age groups (ages 2-18; Child Self-Report Ages 5-7, 8-12, 13-18; Parent Proxy-Report Ages 2-4, 5-7, 8-12, 13-18yrs ). It was found to be reliable between raters and across time. | 3 months | |
Secondary | Mean score change from baseline in parent rated 10 item Likert scale | Likert scale-This is a scale designed to assess the severity of sensory abnormalities in children as per parents. Around 10 questions have been used, 2 each from -visual, tactile, vestibular, proprioceptive and auditory domains. These questions have been framed based on the most common sensory symptoms observed in these children. The scale rates from 1 to 5 , where 1 indicates the lower end of symptom spectrum and 5 the highest end. It is used pre as well as post intervention to compare for any change in sensory processing abnormalities. | 3 months |
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