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Parental Experiences of Home-Based Intensive Segmental Trunk Training in Children With Cerebral Palsy (ISTTvsVT)

2026年7月22日 更新者:Iqra Khan

Parental Experiences of Home-Based Intensive Segmental Trunk Training in Children With Cerebral Palsy: A Feasibility Study

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.

研究概览

详细说明

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.

Weekly tele-supervision: Synchronous video calls between the therapist and caregiver to monitor progress, correct technique, address barriers, and adjust exercise difficulty as needed.

Monthly in-person visits: Face-to-face monitoring at the hospital for clinical reassessment, technique refinement, and reinforcement of training principles.

Participants: Twenty primary caregivers (mothers or fathers) of children aged 4-12 years with a confirmed diagnosis of spastic diplegic CP, classified at Gross Motor Function Classification System (GMFCS) levels II-IV, who were willing to commit to the 12-week program and had access to a smartphone with video-calling capability.

Outcome Measures:

Primary outcomes:

Adherence rate (percentage of prescribed sessions completed over 12 weeks) Caregiver experiences and perceptions (assessed via the KABA [Knowledge, Attitudes, Barriers, and Adherence] survey administered at baseline and week 12, and a semi-structured qualitative interview at study completion)

Secondary outcomes (pre-post comparison):

Trunk control measured by the Segmental Assessment of Trunk Control (SATCo) Gross motor function measured by the Gross Motor Function Measure-88 (GMFM-88)

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Punjab Province
      • Lahore、Punjab Province、巴基斯坦、54000
        • Pediatric Physical Therapy and Neurorehabilitation Department at the University of Lahore Teaching Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Home-Based Intensive segmental Trunk Training Program
All 20 caregiver-child dyads received a 12-week home-based Intensive Segmental Trunk Training (ISTT) program. The intervention included an initial in-person orientation session, daily home-based trunk stabilization exercises guided by pre-recorded instructional videos and a picture-based manual, weekly tele-supervision video calls with a pediatric physical therapist, and monthly face-to-face monitoring visits at the hospital. No control, placebo, or sham comparator arm was included in this feasibility study.
A 12-week structured, progressive trunk stabilization protocol targeting segmental control of the cervical, upper thoracic, lower thoracic, and lumbar regions of the spine. The program consisted of daily home-based sessions (approximately 30 minutes per session), guided by pre-recorded instructional videos and a picture-based manual developed specifically for this study. Exercises progressed from supported to unsupported positions and from static to dynamic tasks. Caregivers received an initial in-person orientation session at a hospital, followed by weekly tele-supervision video calls with a senior pediatric physical therapist to monitor progress, correct technique, address barriers, and adjust exercise difficulty. Monthly face-to-face monitoring visits were conducted at the hospital for clinical reassessment and reinforcement of training principles.
其他名称:
  • Home-based trunk stabilization program
  • caregiver-delivered ISTT

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Adherence Rate
大体时间: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.
Week 12 (end of intervention)
Caregiver Experiences and Perceptions (Qualitative)
大体时间: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.
Week 12 (semi-structured interview)
Caregiver Knowledge, Attitudes and Barriers
大体时间: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.
Baseline and Week 12

次要结果测量

结果测量
措施说明
大体时间
Segmental Assessment Trunk Control (SATCo)
大体时间:Baseline and Week 12
Segmental Assessment of Trunk Control (SATCo) evaluates segmental trunk control across cervical, upper thoracic, lower thoracic, and lumbar regions. Scores range from 0 to 20, with higher scores indicating better trunk control.
Baseline and Week 12
Gross Motor Function Measure-88 (GMFM-88)
大体时间:Baseline and Week 12
Gross Motor Function Measure-88, a standardized observational instrument assessing gross motor function across five dimensions (lying and rolling; sitting; crawling and kneeling; standing; walking, running, and jumping). Scores range from 0 to 100, with higher scores indicating better gross motor function.
Baseline and Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 学习椅:Ashfaq Ahmad, PhD、University of Lahore

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年4月12日

初级完成 (实际的)

2025年10月10日

研究完成 (实际的)

2026年4月10日

研究注册日期

首次提交

2026年7月18日

首先提交符合 QC 标准的

2026年7月22日

首次发布 (实际的)

2026年7月27日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月22日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

This was a small feasibility study conducted at a single center with a limited sample size (n = 20). Individual participant data are not planned for sharing due to confidentiality considerations and the feasibility nature of the study protocol.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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