Parental Experiences of Home-Based Intensive Segmental Trunk Training in Children With Cerebral Palsy (ISTTvsVT)
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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)
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Pediatric Physical Therapy and Neurorehabilitation Department at the University of Lahore Teaching Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Adherence Rate
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Segmental Assessment Trunk Control (SATCo)
Aikaikkuna: 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)
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojen puheenjohtaja: Ashfaq Ahmad, PhD, University of Lahore
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- UOL/IREB/26/21.1/01/02
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .