Cerebral Palsy (CP)NCT07692087
Effect of Intensive Segmental Trunk Training on Upper Extremity Function and Seated Postural Stability in Children With Spastic Diplegic Cerebral Palsy
A study testing Intensive Segmental Trunk Training and Standard Physical Therapy in people with Cerebral Palsy (CP) and Diplegic Cerebral Palsy, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP), Diplegic Cerebral Palsy, Trunk Mobility
- What is being tested?
- Intensive Segmental Trunk Training and Standard Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 24 May 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pediatric Physical Therapy and Neurorehabilitation Department at the University of Lahore Teaching Hospital
Lahore, Punjab Province
About this study
Official title: 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).
Read the 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.
- Conditions
- Cerebral Palsy (CP), Diplegic Cerebral Palsy, Trunk Mobility, Upper Extremity Function, Postural Stability, Diplegic Spastic Cerebral Palsy
- Being tested
- Intensive Segmental Trunk Training, Standard Physical Therapy
- Keywords
- cerebral palsy, postural stability, trunk control, Upper extremity, seated position, motor skills, spastic diplegic cerebral palsy
- Medical subject headings
- Cerebral Palsy, Cerebral palsy, spastic, diplegic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Segmental Trunk TrainingOther
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.
Standard Physical TherapyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately post-intervention (Week 8)
Secondary outcomes (4)
Quality of Upper Extremity Skills Test (QUEST) - Change in upper extremity function
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.
Measured: Baseline, immediately post-intervention (Week 8)
Box and Block Test (BBT) - Change in manual dexterity
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.
Measured: Baseline, immediately post-intervention (Week 8)
Gross Motor Function Measure (GMFM-88) - Change in gross motor function
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.
Measured: Baseline, immediately post-intervention (Week 8)
Trunk Control Test (TCT) - change in trunk control
A standardized test evaluating trunk control ability. Higher scores indicate better trunk control function.
Measured: Baseline, immediately post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start24 May 2024
- Primary completion30 Oct 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore Hospital (ULH)
- Responsible party
- Principal investigator, Iqra Khan, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692087
- Sponsor's protocol ID
- UOL/IREB/26/21.1/01/01
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07692087
- Acronym / sponsor ID
- UOL/IREB/26/21.1/01/01
- Conditions
- Cerebral Palsy (CP), Diplegic Cerebral Palsy, Trunk Mobility, Upper Extremity Function, Postural Stability, Diplegic Spastic Cerebral Palsy
- Keywords
- cerebral palsy, postural stability, trunk control, Upper extremity, seated position, motor skills, spastic diplegic cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Collaborators
- University of Lahore Hospital (ULH)
- Study start
- 24 May 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Segmental Trunk Training (ISTT) Group | Experimental | Other: Intensive Segmental Trunk TrainingParticipants 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. |
| Control Group (Standard Physical Therapy) | Active comparator | Other: Standard Physical TherapyParticipants 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Segmental Trunk TrainingA 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. | Other | Intensive Segmental Trunk Training (ISTT) Group |
| Standard Physical TherapyConventional 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). | Other | Control Group (Standard Physical Therapy) |
Primary outcome
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.
4 secondary outcomes
Quality of Upper Extremity Skills Test (QUEST) - Change in upper extremity function
Time frame: Baseline, immediately post-intervention (Week 8)
Box and Block Test (BBT) - Change in manual dexterity
Time frame: Baseline, immediately post-intervention (Week 8)
Gross Motor Function Measure (GMFM-88) - Change in gross motor function
Time frame: Baseline, immediately post-intervention (Week 8)
Trunk Control Test (TCT) - change in trunk control
Time frame: Baseline, immediately post-intervention (Week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Segmental Trunk Training and Standard Physical Therapy in people with Cerebral Palsy (CP) and Diplegic Cerebral Palsy, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Segmental Assessment of Trunk Control (SATCo) - change in seated postural stability (time frame: Baseline, immediately post-intervention (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.