Parental Experiences of Home-Based Intensive Segmental Trunk Training in Children With Cerebral Palsy: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adherence Rate
研究概览
简要总结
The goal of this feasibility study is to evaluate the adherence, parental experiences, and perceptions of a home-based Intensive Segmental Trunk Training (ISTT) program for children aged 4-12 with spastic diplegic cerebral palsy (CP) in Pakistan. The main questions it aims to answer are:
What is the rate of caregiver adherence to a home-based ISTT program over 12 weeks? What are the primary barriers, experiences, and perceptions of caregivers implementing the program? What are the preliminary signals of clinical effectiveness on trunk control and gross motor function? Researchers will compare pre- and post-intervention outcomes (baseline vs. week 12) to see if there are statistically significant improvements in trunk control (measured by SATCo) and gross motor function (measured by GMFM-88).
Participants (20 primary caregivers and their children) will:
Attend an initial in-person orientation session to learn trunk stabilization exercises from a senior pediatric physical therapist Complete a 12-week home-based ISTT program with weekly tele-supervision video calls to monitor progress and address challenges Attend monthly face-to-face monitoring visits at the hospital for clinical assessment and technique reinforcement Complete a KABA (Knowledge, Attitudes, Barriers, and Adherence) survey at baseline and week 12 Participate in a semi-structured interview at the end of the 12-week program to share their experiences.
详细描述
This single-arm feasibility study was conducted at a hospital in Lahore, Pakistan, to investigate parental experiences and adherence to a home-based Intensive Segmental Trunk Training (ISTT) program for children with spastic diplegic cerebral palsy (CP).
Background: Trunk control is a fundamental prerequisite for gross motor function, postural stability, and functional mobility in children with CP. Conventional clinic-based rehabilitation in Pakistan faces significant challenges including transportation barriers, high costs, and limited access to specialized pediatric physical therapy services, resulting in poor adherence and suboptimal outcomes. Home-based, caregiver-delivered programs offer a promising alternative, but evidence is limited on their feasibility and acceptability in low-resource settings.
Intervention: The ISTT program is a structured, progressive trunk stabilization protocol targeting segmental control of the cervical, upper thoracic, lower thoracic, and lumbar regions of the spine. The 12-week intervention was delivered through a hybrid model:
Week 1: In-person orientation and training session at the hospital, where a senior pediatric physical therapist taught caregivers the exercise protocol, including proper positioning, facilitation techniques, and progression criteria using both verbal instruction and practical demonstration.
Weeks 1-12: Daily home-based sessions (approximately 30 minutes), guided by a library of pre-recorded instructional videos and a picture-based manual developed specifically for this program. Exercises progressed from supported to unsupported positions and from static to dynamic tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This was an open-label, single-arm feasibility study with no blinding. All participants (caregivers and their children), the care provider (pediatric physical therapist conducting tele-supervision), and the investigator assessing outcomes were aware of the intervention assignment, as the study was designed to evaluate real-world feasibility and caregiver experiences with a home-based program.
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-12 years with a confirmed diagnosis of spastic diplegic cerebral palsy
- •Gross Motor Function Classification System (GMFCS) levels II-IV
- •Primary caregiver (mother or father) willing to commit to the 12-week program
- •Caregiver had access to a smartphone with video-calling capability
- •Caregiver able to understand and follow instructions in Urdu or English
排除标准
- •Children with uncontrolled seizures
- •Children who had undergone orthopedic surgery or botulinum toxin injections in the lower extremities within the previous 6 months
- •Children with severe visual or hearing impairments that would interfere with participation
- •Caregivers with a diagnosed physical or mental health condition that would prevent them from safely delivering the home-based program
结局指标
主要结局
Adherence Rate
时间窗: Week 12 (end of intervention)
Percentage of prescribed home-based ISTT sessions completed by caregivers over the 12-week intervention period, calculated as (number of sessions completed / number of sessions prescribed) × 100. Adherence was cross-validated through caregiver self-report and observation during weekly tele-supervision video calls.
Caregiver Experiences and Perceptions (Qualitative)
时间窗: Week 12 (semi-structured interview)
Measured using a semi-structured qualitative interview conducted at the end of the intervention to explore caregivers' experiences, challenges, and perceived benefits of the home-based program.
Caregiver Knowledge, Attitudes and Barriers
时间窗: Baseline and Week 12
Measured using the KABA (Knowledge, Attitudes, Barriers, and Adherence) survey, administered at baseline and Week 12, to assess caregivers' knowledge, attitudes, and perceived barriers to the home-based Intensive Segmental Trunk Training program.
次要结局
- Segmental Assessment Trunk Control (SATCo)(Baseline and Week 12)
- Gross Motor Function Measure-88 (GMFM-88)(Baseline and Week 12)
研究者
Iqra Khan
Principal Investigator
University of Lahore