NCT07692087

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 2, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

cerebral palsypostural stabilitytrunk controlUpper extremityseated positionmotor skillsspastic diplegic cerebral palsy

Outcome Measures

Primary Outcomes (1)

  • Segmental Assessment of Trunk Control (SATCo) - change in seated postural stability

    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 Outcomes (4)

  • Quality of Upper Extremity Skills Test (QUEST) - Change in upper extremity function

    Baseline, immediately post-intervention (Week 8)

  • Box and Block Test (BBT) - Change in manual dexterity

    Baseline, immediately post-intervention (Week 8)

  • Gross Motor Function Measure (GMFM-88) - Change in gross motor function

    Baseline, immediately post-intervention (Week 8)

  • Trunk Control Test (TCT) - change in trunk control

    Baseline, immediately post-intervention (Week 8)

Study Arms (2)

Intensive Segmental Trunk Training (ISTT) Group

EXPERIMENTAL

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.

Other: Intensive Segmental Trunk Training

Control Group (Standard Physical Therapy)

ACTIVE COMPARATOR

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.

Other: Standard Physical Therapy

Interventions

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.

Intensive Segmental Trunk Training (ISTT) Group

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).

Control Group (Standard Physical Therapy)

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Cerebral PalsyCerebral palsy, spastic, diplegic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 9, 2026

Study Start

May 24, 2024

Primary Completion

October 30, 2024

Study Completion

March 30, 2025

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Immediately following publication and with no end date.
Access Criteria
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

Locations