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

NCT07729124 | Completed DMC

• 1 other identifier: UOL/IREB/26/21.1/01/02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy (CP); Home-based Rehabilitation; Home-based Programs; Postural Control; Perceptions; Telerehabilitation

Keywords

Cerebral Palsy; Home care services; Motor Skills; Patient adherence; Postural balance; Tele-support therapy; Tele Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Adherence Rate

  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)

  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

  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

Secondary Outcomes (2)

• Segmental Assessment Trunk Control (SATCo)

  Baseline and Week 12

• Gross Motor Function Measure-88 (GMFM-88)

  Baseline and Week 12

Study Arms (1)

Home-Based Intensive segmental Trunk Training Program

EXPERIMENTAL

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.

Other: Home-Based Intensive Segmental Trunk Training (ISTT)

Interventions

Home-Based Intensive Segmental Trunk Training (ISTT) OTHER

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.

Also known as: Home-based trunk stabilization program, caregiver-delivered ISTT

Home-Based Intensive segmental Trunk Training Program

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iqra Khan: lead
• University of Lahore: collaborator

Study Sites (1)

Pediatric Physical Therapy and Neurorehabilitation Department at the University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy; Patient Compliance

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ashfaq Ahmad, PhD

  University of Lahore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This was a single-arm, open-label feasibility study with no control group or comparator arm. All 20 caregiver-child dyads received the same home-based Intensive Segmental Trunk Training (ISTT) program over 12 weeks. Outcomes were measured at baseline and at the end of the 12-week intervention period (pre-post design). There was no randomization, no parallel group, and no crossover of interventions.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 27, 2026
• Study Start: April 12, 2025
• Primary Completion: October 10, 2025
• Study Completion: April 10, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)