CompletedNot Applicable

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

Pakistan20 participantsStarted 2025-04-12

Plain-language 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.

Who can participate

Age range

4 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adherence Rate

Timeframe: Week 12 (end of intervention)

Caregiver Experiences and Perceptions (Qualitative)

Timeframe: Week 12 (semi-structured interview)

Caregiver Knowledge, Attitudes and Barriers

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT07729124

SponsorIqra Khan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-10

View on ClinicalTrials.gov More Cerebral Palsy (CP) trials