Effect of Multidimensional Trunk Training in Children With Cerebral Palsy

NCT ID: NCT07034872

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2027-06-20

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.

Detailed Description

Cerebral Palsy (CP) is defined as a chronic condition characterized by non-progressive disorders that occur in early childhood and affect motor development, leading to functional limitations. Among the different types of CP, spastic CP is the most common. In children with spastic CP, impairments in the development of balance and protective reactions, associated reaction patterns, and stereotypical movement patterns form the basis of postural control deficits. Achieving trunk control during early childhood is considered a crucial indicator for future ambulation. It is known that age three is a critical milestone in the motor development of children with CP, and approximately one in three children cannot attain adequate trunk control for stable and independent sitting by this age. A moderate correlation has been reported between trunk control, balance parameters, and gait capacity in children with spastic CP.

Evaluating the clinical characteristics of impaired postural control in children with CP and applying appropriate rehabilitation methods is of great importance for promoting independence in activities of daily living. In CP rehabilitation, interventions aiming to improve postural control have shown moderate-quality evidence regarding the effectiveness of trunk-focused training. However, the absence of standardized protocols for such interventions remains a significant limitation in tailoring therapies to individual needs.

This study aims to contribute to the literature by investigating the potential effects of a personalized, multidimensional, trunk-focused exercise program implemented in addition to conventional rehabilitation on postural control development (including static and dynamic trunk control, standing balance, and gait), selective motor control, posture, spasticity level, activity and participation levels, and quality of life in children with spastic CP. Furthermore, the project aims to complement face-to-face therapies with home-based exercises guided by caregivers using individualized exercise prescriptions delivered through a web-based platform and mobile application. This approach is expected to enhance caregiver knowledge and competence, ensure regular exercise adherence, and support the sustainability of the therapeutic process at home.

Children with spastic cerebral palsy who meet the inclusion criteria will be evaluated in terms of trunk control, balance, posture, selective control of upper and lower extremities, spasticity, gait, activity and participation levels, and quality of life, and will be randomly assigned into two groups. The study will last for eight weeks, during which all participants will receive therapy three times per week: two face-to-face sessions with a physiotherapist and one home-based session using asynchronous video-guided exercises delivered via a web-based platform and/or mobile application, under caregiver supervision. During each session over the eight-week intervention period, the study group will receive 30 minutes of a multidimensional trunk-focused exercise program in addition to 30 minutes of conventional therapy, whereas the control group will receive 60 minutes of conventional therapy. At the end of the eighth week, all initial assessments will be repeated for both groups.

The study aims to demonstrate the effects of a personalized multidimensional trunk-focused exercise training program on postural control, gait, and activity levels in adolescents with spastic-type cerebral palsy. Furthermore, the sustainability of the therapeutic process will be supported through the home-based implementation of these exercises under caregiver supervision, facilitated by the web-based system and mobile application TeleRehab4Kids.

Conditions

Cerebral Palsy (CP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Intervention Group

Intervention Type: 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.

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: 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.

Interventions

Control Group

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.

Intervention Type: OTHER

Intervention Group

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 Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Irem Nur Sener

Doctorate Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

İrem Nur Sener

Role: CONTACT

iremnsener1995@gmail.com

905393446762

Facility Contacts

Irem Nur Sener

Role: primary

iremnsener1995@gmail.com

905393446762

Other Identifiers

IUC2025/105

Identifier Type: -

Identifier Source: org_study_id