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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.
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 ,
Compliance would be ensured by the
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Standard therapy alone | No Intervention | Standard therapy -Conventional physiotherapy, occupational,behavioural intervention and pharmacotherapy that they are already receiving |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Children of either sex aged 3 to 12 years clinically diagnosed to have spastic cerebral palsy
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
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Sheffali Gulati, M.D | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All india institute of Medical sciences | Delhi | South Delhi | 110029 | India |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Single Blind Randomized Controlled Parallel Design trial
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| 3 months |
| 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 |
| 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 |