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临床试验/NCT07522086
NCT07522086已完成不适用

The Effectiveness of Client-Centered Occupational Therapy Intervention for Caregivers of Children With Cerebral Palsy

Selin Başak Arslaner1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年10月8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
34
试验地点
1
主要终点
Occupational Balance Questionnaire

研究概览

简要总结

This study examines a client-centered occupational therapy program developed for caregivers of children with cerebral palsy. Caregivers often have difficulty managing their daily activities because of caregiving responsibilities, which can affect how they organize their daily routines.

In this study, caregivers take part in an 8-week program that focuses on improving daily life balance through goal setting, awareness of time use, and activity planning. The program is designed to help caregivers better organize their daily routines and balance different types of activities.

Participants are randomly assigned to either an intervention group or a control group. Outcomes such as daily activity balance, activity performance, and caregiving-related difficulties are measured before and after the program.

The aim of this study is to examine whether a client-centered occupational therapy program can improve daily life balance and activity performance and reduce caregiving-related difficulties in caregivers of children with cerebral palsy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • for Caregivers:
  • Being the primary caregiver of a child with diplegic CP.
  • Having access to a device with internet connectivity.
  • Being capable of following verbal and written instructions.
  • Volunteering to participate in the study.
  • Scoring 5 or below in the Performance and Satisfaction dimensions of the Canadian Occupational Performance Measure (COPM) or scoring 16 or below on the Occupational Balance Questionnaire.
  • Scoring 21 or above on the Caregiver Burden Scale.

排除标准

  • for Caregivers:
  • Had previously received professional services or interventions specifically designed for caregivers,
  • Had a neurological, psychiatric, or chronic condition, such as multiple sclerosis, schizophrenia, or diabetes
  • Using medications (e.g., sedatives, antidepressants, or potent analgesics)
  • Inclusion Criteria for Children:
  • Being between the ages of 4 and 18 years.
  • Being classified as Level IV or above according to the Gross Motor Function Classification System (GMFCS).
  • Being classified as Level III or above according to the Manual Ability Classification System (MACS).
  • Being classified as Level II or above according to the Communication Function Classification System (CFCS).
  • Being classified as Level III or above according to the Eating and Drinking Ability Classification System (EDACS).
  • Exclusion Criteria for Children:
  • - Having an additional neurological diagnosis alongside CP (e.g., hydrocephalus, epilepsy).

研究组 & 干预措施

Interventiton Group

Active Comparator

Participants in this arm received a structured, client-centered occupational therapy intervention focused on occupational balance. The program consisted of 8 weekly individual sessions (45 minutes each), delivered either face-to-face or online. The intervention was based on Wagman and Håkansson's three dimensions: occupational areas, occupations of different characteristics, and time use. Techniques such as habit stacking, energy conservation, and time management strategies were implemented.

干预措施: Client-Centered Occupational Therapy Intervention (Behavioral)

Control Group

Placebo Comparator

The control group received a single session of occupational balance and life pattern awareness sessions.

干预措施: Control Group Intervention (Behavioral)

结局指标

主要结局

Occupational Balance Questionnaire

时间窗: Baseline and after 8 weeks (post-intervention)

Wagman and Ha˚kansson (2014) developed the Occupational Balance Questionnaire (OBQ), a scale that measures self-rated occupational balance. The questionnaire had good internal consistency (Cronbach's alpha¼0.936) and adequate test-retest reliability (Spearman's rho¼0.926 for total score) in healthy adults. The OBQ was designed to analyze both at-item level and as a summed total score (Wagman, \& Ha˚kansson, 2014). Ha˚kansson et al. (2020) reported that the OBQ11 had good reliability (0.92), model fit, and measurement invariance across age and gender groups. Günal et al. (2020) performed the Turkish adaptation and validity and reliability studies to obtain the OBQ11-T. Test-retest reliability of the OBQ11-T was 0.922, and Cronbach's alpha for OBQ11-T total score was 0.785. The scale consists of 11 items scored on a 4-point scale from 'strongly disagree' (scored 0) to 'strongly agree' (scored 3). The total score is obtained by summing the individual items and ranges from 0 to 33. Higher

Canadian Occupational Performance Measure (COPM)

时间窗: Baseline and after 8 weeks (post-intervention)

It is a semi-structured scale that helps to identify problematic areas of performance experienced by individuals and to measure their perceived occupational performance and occupational satisfaction. This scale assesses the level of performance of self-care, productivity and leisure occupations and satisfaction with these performances as perceived by the individual. The importance of each occupation is measured on a 10-point scale (1 = not at all important, 10 = very important) according to the individual's perception. In the next step, the individual is asked to select five occupations that he/she considers most important and to rate separately his/her performance (1 = could not do it, 10 = could do it very well) and satisfaction (1 = not satisfied, 10 = very satisfied) in these occupations (Torpil et al., 2021). Cronbach's alpha for COPM Turkish total score was 0.95.

次要结局

未报告次要终点

研究者

发起方
Selin Başak Arslaner
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Selin Başak Arslaner

Lecturer

Lokman Hekim University

研究点 (1)

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