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临床试验/NCT03596515
NCT03596515已完成不适用

Occupational Therapy With Ayres Sensory Integration Approach for School-age Children - a Randomized Controlled Trial

Hospital Authority, Hong Kong0 个研究点目标入组 52 人开始时间: 2014年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
主要终点
Change on the Goal attainment scaling. Changes in functional goals were measured using goal attainment scaling in collaboration with parents and caregivers.

研究概览

简要总结

Introduction:

Sensory Integration (SI) is a theory and framework conceptualized by Dr. Jean Ayres, a highly experienced occupational therapist, with its main objective as enhancing the brain's capacity to perceive and organize sensory information to produce a more normal, adaptive response; thus, to provide the foundation for mastering academic tasks (Case-Smith and O'Brien, 2010).

Objectives:

The aim of the study is to investigate the effectiveness of ASI interventions for school-aged children with sensory modulation and sensory processing deficits.

Methodology:

A cross-clustered single-blinded randomized controlled trial was conducted in 5 occupational therapy outpatient department within Hospital Authority, to assess the difference in clinical outcomes between subjects in experimental group (received ASI) and control group (on usual waitlist for treatment). Participants in experimental group (EG) would receive 16 sessions (45 minutes each) of individualized ASI. The sessions were scheduled on weekly basis and would be completed within five months once treatment was initiated. Post-assessment outcomes would be measured at this time-point. Post-assessment outcomes would also be measured for subjects in control group (CG) at the same time-point. ASI would then be initiated for participants in CG according to usual clinical scheduling.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • aged between six and 12 years old, and attending mainstream primary school
  • identified as having problems with sensory modulation and/or sensory processing, according to the Sensory Integration and Praxis Test (SIPT) and the Chinese Sensory Profile completed by their main caregivers for pre-treatment evaluation (definite differences on at least three out of seven of the factor summary or section summary)
  • absence of serious emotional or behavioral disturbance
  • intelligence quotient no lower than limited (scores range from limited to average or above average).

排除标准

  • any neurological problem, such as cerebral palsy
  • a history of visual and/or auditory defects or physical problems

研究组 & 干预措施

Received sensory integration therapy

Experimental

Participants in the experimental group received 16 sessions (45 minutes each) of individualized Ayres Sensory Integration intervention.

干预措施: Sensory Integration (Other)

Waitlist control group

No Intervention

Participants in the control group received Ayres Sensory Integration according to the usual clinical scheduling. It is after the post- assessment outcome at the same time of the experimental group.

结局指标

主要结局

Change on the Goal attainment scaling. Changes in functional goals were measured using goal attainment scaling in collaboration with parents and caregivers.

时间窗: Pre and post of the treatment intervention, an average of 5 months

Goal attainment scaling (GAS) is the full name of this scale. It is an individualized, criterion-referenced measures of changes. In involves defining a set of unique goals for a client, and then specifying a range of outcomes, which reflect concrete activities. It is a goal-setting process determining intervention outcomes expressly relevant to individuals and their families. It can show functional and meaningful outcomes that are often challenging to assess using standardized measures. It is a 5-point rating scale ranging from -2 to +2 (-2 is the least favorable treatment outcome, 0 is the predicted expected level of performance, and +2 is the most favorable treatment outcome). In this study, three individualized goals were developed for each participant by occupational therapists in conjunction with the parents or caregivers. The occupational therapists transferred the score of each child in each goal in the pre- and post-assessments according to parents' ratings.

Change on the Sensory Integration and Praxis Test scores

时间窗: Pre and post of the treatment intervention, an average of 5 months

Sensory Integration and Praxis Test (SIPT) is the full name of this scale. This is a standardized test for assessing the sensory integration and praxis of children between the ages of four years and eight years, eleven months. This study used six subtests of the SIPT - standing and walking balance, postural praxis, post-rotary nystagmus, motor accuracy, sequencing praxis, and graphesthesia - based on expert opinions. SIPT offers is computer scoring and interpretation. Therapists simply record the child's performance and enter into the software. The software will generates the S.D. scores and percentile scores. Average SD scores are usually considered to fall between -1 to +1. Scores below -2 generally indicate definite problems, while scores between -2 and -1 are indicative of possible problems.

Change on the Chinese Sensory Profile

时间窗: Pre and post of the treatment intervention, an average of 5 months

Chinese Sensory Profile is the full name of this scale.This is a judgment-based questionnaire answered on a 5-point Likert scale. It is regarded as a standardized assessment for screening the sensory processing abilities of children between the ages of three and 12 years. Score each response according to the following criteria:1. Always = 1 point; 2. Frequently = 2 points; 3. Occassionally = 3 points; 4. Seldom = 4 points; 5. Never = 5 points.To determine the section raw score total, add the item scores for each section and transfer the total to the section summary table. Plot the child's section raw score totals in the classification column corresponding to the raw score total for each section.Cut scores were determined for each section in the following manner: 1. Typical performance includes scores at or above 1 S.D. below the mean; 2. Probable difference is includes scores at or above 2 S.D. below the mean; 3. Definite difference is includes scores below 2 S.D. below the mean.

次要结局

未报告次要终点

研究者

发起方
Hospital Authority, Hong Kong
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Phoebe Chan

Occupational Therapist I, Occupational Therapy Department, Principal Investigator, Hong Kong Children's Hospital

Hospital Authority, Hong Kong

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