Comparison of Efficacy of Sensory Integration Therapy in Children With Cerebral Palsy
2019년 11월 21일 업데이트: Sheffali Gulati, All India Institute of Medical Sciences, New Delhi
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
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.
연구 개요
상세 설명
- 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
연구 유형
중재적
등록 (실제)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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South Delhi
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Delhi, South Delhi, 인도, 110029
- All India Institute of Medical Sciences
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
3년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: SIT plus standard therapy
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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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.
다른 이름들:
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간섭 없음: Standard therapy alone
Standard therapy -Conventional physiotherapy, occupational,behavioural intervention and pharmacotherapy that they are already receiving
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean change in GMFM-88 Score from baseline
기간: 3 months
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean T score change from baseline in CBCL
기간: 3 months
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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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3 months
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Mean score change from baseline in Pediatric quality of life scale from baseline
기간: 3 months
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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.
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3 months
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Mean score change from baseline in parent rated 10 item Likert scale
기간: 3 months
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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.
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3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Sheffali Gulati, M.D, Professor
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 7월 25일
기본 완료 (실제)
2019년 8월 16일
연구 완료 (실제)
2019년 8월 16일
연구 등록 날짜
최초 제출
2018년 5월 10일
QC 기준을 충족하는 최초 제출
2019년 3월 22일
처음 게시됨 (실제)
2019년 3월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 11월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 11월 21일
마지막으로 확인됨
2019년 11월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .