Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Effect of Intensive Segmental Trunk Training on Upper Extremity Function and Seated Postural Stability in Children With Spastic Diplegic Cerebral Palsy

28 juillet 2026 mis à jour par: Iqra Khan, University of Lahore

Effect of Intensive Segmental Trunk Training on Upper Extremity Function and Seated Postural Stability in Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial

The goal of this randomized controlled trial is to evaluate whether intensive segmental trunk training (ISTT) can improve upper extremity function and seated postural stability in children aged 4-12 years with spastic diplegic cerebral palsy and moderate trunk control impairments. The main questions it aims to answer are:

Does intensive segmental trunk training lead to greater improvements in seated postural stability compared to standard physical therapy? Does intensive segmental trunk training lead to greater improvements in upper extremity function compared to standard physical therapy? Researchers compared the ISTT group to the control group (standard physical therapy) to see if the targeted trunk training produces significantly better outcomes in trunk control, upper extremity skills, and gross motor function.

Participants underwent their assigned training regimen five times per week for eight weeks and complete pre- and post-intervention assessments measuring trunk control (SATCo, TCT), upper extremity function (QUEST, Box and Block Test), and gross motor function (GMFM-88).

Aperçu de l'étude

Description détaillée

This single-blind randomized controlled trial investigated the efficacy of intensive segmental trunk training (ISTT) as a targeted intervention for improving seated postural control and upper limb function in children with spastic diplegic cerebral palsy (CP). Trunk control deficits are a hallmark impairment in this population, contributing to compromised upper extremity function, reduced seated stability, and limitations in activities of daily living. While conventional physical therapy often addresses trunk control indirectly, this study evaluated whether a structured, segment-specific approach yields superior outcomes.

Thirty children aged 4-12 years with spastic diplegic CP and Gross Motor Function Classification System (GMFCS) levels II-IV were recruited from outpatient neurorehabilitation center. Inclusion required moderate trunk control impairment, defined as a score of ≤ 3 on the Trunk Control Test (TCT) item assessing sitting without arm support. Children with uncontrolled seizures, Botulinum toxin injections within the preceding six months, orthopedic surgery within the past year, or cognitive impairment that would preclude task comprehension were excluded.

Participants were randomly assigned to either the ISTT group (n = 15) or the control group (n = 15) using a computer-generated sequence (www.randomization.com) produced by an independent researcher, uninvolved in recruitment, intervention, or assessment. Allocation was concealed in sequentially numbered, opaque, sealed envelopes opened only after baseline measures were complete. The ISTT group received specialized training targeting segmental trunk control at the thoracic, lumbar, and pelvic levels. Training sessions, conducted five times weekly for eight weeks (40 sessions total, 60 minutes each), incorporated graded exercises progressing from static to dynamic sitting balance. Key ISTT components included pelvic tilt facilitation, isolated thoracic and lumbar segmental mobilization during weight shifting, trunk rotation with reaching tasks, and perturbation-based reactive balance training using a tilt board. Exercises were progressively advanced based on individual tolerance and performance.

The control group received standard physical therapy of equal duration and frequency, emphasizing neurodevelopmental treatment (NDT) principles, passive stretching of lower extremity muscles, strengthening of the lower limbs, and gait training.

Outcome measures were assessed at baseline and immediately post-intervention (week 8). The primary outcomes were seated postural stability, measured by the Segmental Assessment of Trunk Control (SATCo). Secondary outcomes included the Trunk Control Test (TCT), upper extremity function, assessed via the Quality of Upper Extremity Skills Test (QUEST) and the Box and Block Test (BBT), and gross motor function, measured by the Gross Motor Function Measure (GMFM-88); Dimensions D (Standing) and E (Walking, Running, Jumping) monitored for unintended change in gross motor function. All assessments were performed by a blinded pediatric physical therapist.

Sample size was calculated a priori using G*Power (version 3.1.9.7). A pilot study of 8 participants (4 per group) yielded a partial eta-squared of 0.14 for the group × time interaction on the Box and Block Test, the primary outcome. With alpha 0.05, power 0.80, two groups, and two measurement points, 22 participants (11 per group) were required; accounting for an anticipated 25% dropout, 30 participants (15 per group) were recruited. The primary analysis used a 2 × 2 mixed-model ANOVA with group (ISTT, control) as the between-subjects factor and time (baseline, post-intervention) as the within-subjects factor; the group × time interaction was the effect of primary interest, with partial eta-squared (η²p) as the effect-size measure (small ≥ 0.01, moderate ≥ 0.06, large ≥ 0.14). Significant interactions were followed by paired t-tests within group and independent t-tests at each time point, with Bonferroni correction for multiple comparisons.

The study was approved by the institutional ethics committee. Written informed consent was obtained from parents or legal guardians.

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Pediatric Physical Therapy and Neurorehabilitation Department at the University of Lahore Teaching Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Participants included were aged 4-12 years
  • Gross Motor Function Classification System (GMFCS) Levels II-IV
  • ability to sit independently for at least 10 seconds
  • follow simple verbal instructions
  • moderate trunk control impairment, defined as a score of ≤ 3 on the Trunk Control Test (TCT) item assessing sitting without arm support
  • Children with trunk control scores within a moderate impairment range on the Segmental Assessment of Trunk Control (SATCo).
  • Parental consent was obtained prior to participation.

Exclusion Criteria:

  • Children with cognitive impairments severe enough to limit task comprehension
  • uncontrolled seizures
  • history of surgical interventions or Botulinum toxin injections in the preceding 6 months
  • receiving other therapeutic interventions targeting trunk control or upper limb function concurrently were excluded.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intensive Segmental Trunk Training (ISTT) Group
Participants received specialized segmental trunk training targeting the thoracic, lumbar, and pelvic levels, five times per week for eight weeks (40 sessions, 60 minutes each). Exercises progressed from static to dynamic seated balance and included pelvic tilt facilitation, isolated segmental mobilization during weight shifting, trunk rotation with reaching tasks, and perturbation-based reactive balance training using a tilt board.
A structured, progressive training program targeting segmental trunk control at the thoracic, lumbar, and pelvic levels. Conducted five times per week for eight weeks (40 sessions, 60 minutes each). Exercises progress from static to dynamic seated balance and include pelvic tilt facilitation, isolated segmental mobilization during weight shifting, trunk rotation with reaching tasks, and perturbation-based reactive balance training using a tilt board. Difficulty is advanced based on individual tolerance and performance.
Comparateur actif: Control Group (Standard Physical Therapy)
Participants received standard physical therapy of equal duration and frequency (five times per week for eight weeks, 60 minutes per session), emphasizing neurodevelopmental treatment (NDT) principles, passive stretching of lower extremity muscles, lower limb strengthening, and gait training.
Conventional physical therapy based on neurodevelopmental treatment (NDT) principles, involving passive stretching of lower extremity muscles, lower limb strengthening, and gait training. Delivered at the same frequency and duration as the experimental intervention (five times per week, 60 minutes per session, for eight weeks).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Segmental Assessment of Trunk Control (SATCo) - change in seated postural stability
Délai: Baseline, immediately post-intervention (Week 8)
A reliable and valid measure that assesses segmental trunk control at cervical, thoracic, and lumbar levels in sitting. Scores range from 0 (no trunk control) to 20 (full segmental trunk control), with higher scores indicating better seated postural stability.
Baseline, immediately post-intervention (Week 8)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Trunk Control Test (TCT) - change in trunk control
Délai: Baseline, immediately post-intervention (Week 8)
A standardized test evaluating trunk control ability. Higher scores indicate better trunk control function.
Baseline, immediately post-intervention (Week 8)
Quality of Upper Extremity Skills Test (QUEST) - Change in upper extremity function
Délai: Baseline, immediately post-intervention (Week 8)
Assesses dissociated movements, grasp, protective extension, and weight bearing in the upper extremities. Scores are expressed as a percentage (0-100%), with higher scores indicating better upper extremity function.
Baseline, immediately post-intervention (Week 8)
Box and Block Test (BBT) - Change in manual dexterity
Délai: Baseline, immediately post-intervention (Week 8)
Measures unilateral manual dexterity by counting the number of blocks transferred from one compartment to another within 60 seconds. Higher scores indicate better manual dexterity.
Baseline, immediately post-intervention (Week 8)
Gross Motor Function Measure (GMFM-88) - Change in gross motor function
Délai: Baseline, immediately post-intervention (Week 8)
A standardized observational measure assessing gross motor function across five dimensions (lying/rolling, sitting, crawling/kneeling, standing, walking/running/jumping). Scores range from 0 to 100%, with higher scores indicating better gross motor function.
Baseline, immediately post-intervention (Week 8)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

24 mai 2024

Achèvement primaire (Réel)

30 octobre 2024

Achèvement de l'étude (Réel)

30 mars 2025

Dates d'inscription aux études

Première soumission

2 juillet 2026

Première soumission répondant aux critères de contrôle qualité

2 juillet 2026

Première publication (Réel)

9 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Data related to underlying results, without personal identification, of the individual will be shared on demand. The datasets generated during and/or analysed during the current study will be available upon request from Dr. Iqra Khan, PT, with email address: iqrakhan485@gmail.com Researchers who will provide a reason with proposal of their study can get access

Délai de partage IPD

Immediately following publication and with no end date.

Critères d'accès au partage IPD

The datasets generated during and/or analysed during the current study will be available upon request from Dr. Iqra Khan, PT, with email address: iqrakhan485@gmail.com

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner