Effects of Trunk-Focused Rehabilitation on Spinal Mobility, Trunk Control, and Hand Functions in Cerebral Palsy

Not Applicable

Recruiting

• Conditions: Cerebral Palsy (CP); Adolescent; Trunk; Exercise

• Registration Number: NCT06781047
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

Main Purpose: This study aims to investigate the effects of trunk-focused rehabilitation on trunk control, spinal mobility, and manual skills in adolescents with cerebral palsy (CP).

Secondary Purpose: To investigate its effects on functional health.

Detailed Description

Muscle weakness in the trunk; reducing the support of children with CP, may cause increased distal tone and decreased function in their daily practices. When the effectiveness of interventions that can improve postural control is evaluated, trunk-focused training is one of the 5 interventions supported by a moderate level of evidence. In an intervention study where trunk training was structured individually, there may be an improvement in erector spinae muscle group scores when evaluated with sEMG. A study of 28 cases, including all subtypes of CP, aimed to evaluate the inter-rater reliability of Spinal Mouse (SM) and the effect on the spinal column with 4 hours a day, 1 week of intensive clinical rehabilitation application. In this population, SM was evaluated with therapeutic interventions, it has been reported that it may show significant posture differences, especially in total spinal inclination and spine length. In children aged 5-12 years with Gross Motor Function Classification System (GMFCS) Level 1, 2 CP, there are significant improvements in the Trunk Control Measurement Scale (TCMS) score after only Trunk Focused Rehabilitation (TFR). It is emphasized that with TFR, which is described as a unique approach, postural control of the whole body can be improved by the use of intermediate postures and postural activities involving the trunk and better participation of the affected muscles. Only after TFR intervention, the findings of improvement in the assessments on a 3D force platform were highlighted in postural sway, early sternal and sacral decelerations. It is carried out with active participation, individualized, intensive, and time-limited, considering possible content limitations and the needs and preferences of the adolescent and the family. It is stated that trunk-targeted interventions can be given together with conventional physical therapy programs to support functional improvements.

Study Timeline

• Study Start: 2024-05-15
• Status Verified: 2024-08
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-05-25
• Study Completion: 2025-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Levels 1 and 2 according to Gross Motor Function Classification System (GMFCS)
2. Viking Speech Scale Turkish version/(VSS-T) 1-2 level, understood to speak and able to take commands
3. Adolescents with CP between the ages of 12-18
4. Those whose guardian / legal representative and themselves have received an Informed Voluntary Consent Form
5. No hip dislocation
6. Scoliosis below 25 degrees according to the radiographic evaluation made in the last 6 months

Exclusion Criteria

1. Having had any surgery related to the intrathecal baclofen pump
2. Having botulinum toxin injection treatment or orthopedic surgery within the last 6 months
3. Having severe vision, hearing, and cognitive deficiencies
4. Acute medical illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of Trunk Control	at baseline and week 9	Trunk Impairment Scale: It consists of coordination, dynamic and static sections. In the static section, the responses in actively and passively crossing the legs with the feet in a supported position are recorded. In the dynamic section, unilateral hip movements and lateral flexion of the trunk are evaluated. In the coordination section, the upper and lower body are asked to move. Coordination consists of dynamic and static sections. The maximum scores that can be obtained from the tests are 7 for the static section, 10 for the dynamic section, and 6 for the coordination section. The score range is 0-23. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
Evaluation of Spinal Mobility	at baseline and week 12	Spinal Mobility and Alignment Assessment (Sagittal Plane): Spinal Mouse (SM) measurements are taken at the same time of day, in an environment where the patient is resting, distrubating their weight equally between their two feet as much as possible, and standing symmetrically, while the patient is standing upright in an anatomical position, by moving downwards at a constant speed over the SM spinal criterion points (from C7 spinous process to S3) by the physiotherapist. The spine is measured 3 times in the sagittal plane. The average value of the measurements is used for analysis.
Evaluation of Hand Functions	at baseline and week 9	Jebsen Taylor Hand Function Test (JTHFT): Writing, card turning, picking up small objects, large and heavy objects skills and durations are assessed in both hands. 7 items are repeated for both hands. The completion time of each task is recorded separately. The score for the subtest is equal to the time in seconds required to complete the task, the maximum score for the subtest is 120. The total score is equal to the sum of points for all subtests and is calculated separately for each hand. The lower the score, the better the child's hand function.

Secondary Outcome Measures

Name	Time	Method
1 Minute Walking Test (1-MWT):	at baseline and week 9	The 1-minute walk test (1-MWT) is a valid and simple assessment for monitoring changes in walking capacity in children with chronic conditions. While performing the 1-MWT, children are asked to walk as fast as they can on a circular track. Running is prohibited. They may use mobility aids if necessary. The distance they travel on the track is recorded.
Pediatric Data Collection Tool (PODCI)	at baseline and week 9	PODCI consists of 5 subscales: Upper Extremity and Physical Function, Transfer and Basic Mobility, Pain/Comfort, Happiness, Sports and Physical Function, and Global Function. PODCI scores are calculated separately for each subscale and range from 0 to 100 points. Higher scores represent better health. The PODCI includes 86 items in 3 scales: global function, happiness, and expectations. The global function scale is the average of 4 subscales: upper extremity and physical function, transfers and basic mobility, sports and physical function, and pain and comfort. Items are scored ranging from 0 to 3 and 0 to 6, with lower scores indicating higher disability level.

Trial Locations

Locations (3)

Sacettin Gürbüz Barrier-Free Life Center (General name of the campus.) /*Private Etimesgut Barrier-Free Life Special Education and Rehabilitation Center; 🇹🇷 Ankara, Etimesgut, Turkey

Private Etimesgut Kardelen Special Education and Rehabilitation Center; 🇹🇷 Ankara, Etimesgut, Turkey

SERÇEV Barrier-Free and Vocational Technical Anatolian High School; 🇹🇷 Ankara, Çankaya, Turkey