Effect of Multidimensional Trunk Training in Children With Cerebral Palsy

NCT07034872 | Not Yet Recruiting

• 1 other identifier: IUC2025/105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effects of a personalized, multidimensional trunk-focused exercise program combined with conventional rehabilitation on postural control, gait, selective motor control, spasticity, activity participation, and quality of life in children with spastic cerebral palsy. Participants will be randomly assigned to an intervention group receiving trunk-focused exercises plus conventional therapy or a control group receiving only conventional therapy over an eight-week period with thrice-weekly sessions (two face-to-face, one home-based via video guidance). The study also incorporates caregiver-supported home exercises facilitated by a web-based platform and mobile application to enhance adherence and sustainability. Outcomes will be assessed pre- and post-intervention to evaluate the program's efficacy in improving motor function and daily activity engagement.

Conditions

Cerebral Palsy (CP)

Keywords

postural control; activity; gait; cerebral palsy

Outcome Measures

Primary Outcomes (2)

• Trunk Control Measurement Scale (TCMS)

  The TCMS consists of two main subcomponents: static and dynamic sitting balance. The static sitting balance section evaluates static trunk control during upper and lower extremity movements and has been shown to be a valid and reliable tool in children with cerebral palsy (Heyrman et al., 2011). The dynamic sitting balance section is further divided into two subcategories: selective movement control and dynamic reaching. The selective movement control subcomponent assesses the pelvis's ability to perform selective movements in all three planes (flexion-extension, lateral flexion, and rotation) while seated on a support surface. The dynamic reaching subcomponent evaluates performance during reaching tasks. The scale consists of 15 items, with a total score ranging from 0 to 58, where higher scores indicate better trunk control.

  Baseline and after 8 weeks

• Pediatric Balance Scale (PBS)

  The Pediatric Balance Scale is an adaptation of the Berg Balance Scale, originally developed for adults, for use in children. It is a functional balance assessment tool consisting of 14 items that evaluate parameters such as sitting to standing, standing, transfers, stepping, and turning (Franjoine M.R. et al., 2003). The scale has been validated for use in children with cerebral palsy in Turkish populations (Erden A. et al., 2021).

  Baseline and after 8 weeks

Secondary Outcomes (9)

• Selective Control of the Upper Extremity Scale (SCUES)

  Baseline and after 8 weeks

• Selective Control Assessment of the Lower Extremity (SCALE)

  Baseline and after 8 weeks

• PostureScreen Mobile®

  Baseline and after 8 weeks

• Modified Ashworth Scale (MAS)

  Baseline and after 8 weeks

• Edinburgh Visual Gait Score (EVGS)

  Baseline and after 8 weeks

Other Outcomes (1)

• Clinical Assessment Form

  Baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive two face-to-face physiotherapy sessions and one asynchronous video-based exercise training session per week for eight weeks. In addition to conventional therapy, this group will undergo a trunk-focused exercise program for the same duration.

Other: Intervention Group

Control Group

ACTIVE COMPARATOR

Participants in the control group will receive two face-to-face physiotherapy sessions and one asynchronous video-based conventional therapy session per week for eight weeks.

Other: Control Group

Interventions

Control Group OTHER

Participants in the control group will receive two face-to-face physiotherapy sessions and one asynchronous video-based exercise training session per week for eight weeks. Following the baseline assessments, a conventional exercise program will be individually planned by the physiotherapist for each child. Each 60-minute session will include strengthening exercises for upper and lower extremity muscles, active and passive stretching exercises for spastic muscles, static and dynamic balance training in standing, and gait exercises.

Control Group

Intervention Group OTHER

Following baseline assessments, a personalized 60-minute exercise program will be developed by the physiotherapist for each child in the intervention group, consisting of two face-to-face sessions and one asynchronous video-based session per week for eight weeks. Each session will include 30 minutes of multidimensional trunk-focused exercises-such as static and dynamic trunk control (e.g., reaching, rotational movements), scapular and pelvic mobilizations, isolated muscle training, proprioceptive activities, and core strengthening-followed by 30 minutes of conventional therapy, including upper and lower extremity strengthening, stretching for spastic muscles, balance training in standing, and gait exercises.

Intervention Group

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with spastic type cerebral palsy
• Aged between 9 and 18 years
• Classified as levels 1, 2, or 3 according to the Gross Motor Function Classification System (GMFCS)

You may not qualify if:

• Having received Botox injections targeting the upper and lower extremities within the last 6 months
• Diagnosed with mental retardation
• Having visual and/or hearing impairments severe enough to affect participation in treatment
• Lack of internet access at home and not possessing digital devices such as a smartphone, tablet, or computer
• Having an additional neurological disorder diagnosis other than cerebral palsy

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

İrem Nur Sener

CONTACT

905393446762; iremnsener1995@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate Student

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 24, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): June 20, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)