- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07692087
Effect of Intensive Segmental Trunk Training on Upper Extremity Function and Seated Postural Stability in Children With Spastic Diplegic Cerebral Palsy
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan
- Pediatric Physical Therapy and Neurorehabilitation Department at the University of Lahore Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Active Comparator: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Segmental Assessment of Trunk Control (SATCo) - change in seated postural stability
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk Control Test (TCT) - change in trunk control
Time Frame: Baseline, immediately post-intervention (Week 8)
|
A standardized test evaluating trunk control ability.
Higher scores indicate better trunk control function.
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Baseline, immediately post-intervention (Week 8)
|
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Quality of Upper Extremity Skills Test (QUEST) - Change in upper extremity function
Time Frame: 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.
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Baseline, immediately post-intervention (Week 8)
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Box and Block Test (BBT) - Change in manual dexterity
Time Frame: Baseline, immediately post-intervention (Week 8)
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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.
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Baseline, immediately post-intervention (Week 8)
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Gross Motor Function Measure (GMFM-88) - Change in gross motor function
Time Frame: Baseline, immediately post-intervention (Week 8)
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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)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOL/IREB/26/21.1/01/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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