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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.

調査の概要

詳細な説明

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)

研究の種類

介入

入学 (実際)

20

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Punjab Province
      • Lahore、Punjab Province、パキスタン、54000
        • Pediatric Physical Therapy and Neurorehabilitation Department at the University of Lahore Teaching Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
他の名前:
  • Home-based trunk stabilization program
  • caregiver-delivered ISTT

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Adherence Rate
時間枠: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)
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Segmental Assessment Trunk Control (SATCo)
時間枠: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)
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディチェア:Ashfaq Ahmad, PhD、University of Lahore

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年4月12日

一次修了 (実際)

2025年10月10日

研究の完了 (実際)

2026年4月10日

試験登録日

最初に提出

2026年7月18日

QC基準を満たした最初の提出物

2026年7月22日

最初の投稿 (実際)

2026年7月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月27日

QC基準を満たした最後の更新が送信されました

2026年7月22日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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