Clinical trial NCT06781047: Effects of Trunk-Focused Rehabilitation on Spinal Mobility, Trunk Control, and Hand Functions in Cerebral Palsy
Official title: Serebral Palsili Adölesanlarda Gövde Odaklı Rehabilitasyonun Spinal Mobilite, Gövde Kontrolü ve El Fonksiyonları Üzerine Etkilerinin İncelenmesi
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Adolescent
Trunk
Exercise
Keywords: cerebral palsy, trunk training, trunk control exercise
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Clinical Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of Trunk Control
timeFrame: at baseline and week 9
measure: Evaluation of Spinal Mobility
timeFrame: at baseline and week 12
measure: Evaluation of Hand Functions
timeFrame: at baseline and week 9
Secondary outcomes:
measure: 1 Minute Walking Test (1-MWT):
timeFrame: at baseline and week 9
measure: Pediatric Data Collection Tool (PODCI)
timeFrame: at baseline and week 9
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sacettin Gürbüz Barrier-Free Life Center (General name of the campus.) /*Private Etimesgut Barrier-Free Life Special Education and Rehabilitation Center
state: Etimesgut
city: Ankara
country: Turkey
facility: Private Etimesgut Kardelen Special Education and Rehabilitation Center
state: Etimesgut
city: Ankara
country: Turkey
facility: SERÇEV Barrier-Free and Vocational Technical Anatolian High School
state: Çankaya
Study officials:
affiliation: University of Health Sciences Hamidiye Faculty of Health Sciences
name: Seval KUTLUTÜRK YIKILMAZ, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Etimesgut Şehit Sait Ertürk State Hospital Orthopedics and Traumatology.
name: Orçun TOKTAŞ, Op. Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health Sciences Hamidiye Health Sciences Institute
name: Gül EVDALI, MScPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. Giannoni P, Zerbino L. Cerebral Palsy: A Practical Guide for Rehabilitation Professionals. Springer International Publishing; 2022. https://books.google.com.tr/books?id=apxhEAAAQBAJ
citation: Dewar R, Love S, Johnston LM. Exercise interventions improve postural control in children with cerebral palsy: a systematic review. Dev Med Child Neurol. 2015 Jun;57(6):504-20. doi: 10.1111/dmcn.12660. Epub 2014 Dec 18.
citation: 3. Akbaş AN, Günel MK. Effects of individually structured trunk training on body function and structures in children with spastic cerebral palsy: A stratified randomized controlled trial. In: Turkish Journal of Physiotherapy and Rehabilitation. Turkish Physiotherapy Association; 2019;30(1) 11-22.
citation: Ruthard K, Raabe-Oetker A, Ruthard J, Oppermann T, Duran I, Schonau E. Reliability of a radiation-free, noninvasive and computer-assisted assessment of the spine in children with cerebral palsy. Eur Spine J. 2020 May;29(5):937-942. doi: 10.1007/s00586-020-06328-4. Epub 2020 Feb 8.
citation: Pierret J, Beyaert C, Vasa R, Rumilly E, Paysant J, Caudron S. Rehabilitation of Postural Control and Gait in Children with Cerebral Palsy: the Beneficial Effects of Trunk-Focused Postural Activities. Dev Neurorehabil. 2023 Apr;26(3):180-192. doi: 10.1080/17518423.2023.2193269. Epub 2023 Mar 23.
citation: Talgeri AJ, Nayak A, Karnad SD, Jain P, Tedla JS, Reddy RS, Sangadala DR. Effect of Trunk Targeted Interventions on Functional Outcomes in Children with Cerebral Palsy- A Systematic Review. Dev Neurorehabil. 2023 Apr;26(3):193-205. doi: 10.1080/17518423.2023.2193265. Epub 2023 Apr 5.
citation: Faccioli S, Pagliano E, Ferrari A, Maghini C, Siani MF, Sgherri G, Cappetta G, Borelli G, Farella GM, Foscan M, Vigano M, Sghedoni S, Perazza S, Sassi S. Evidence-based management and motor rehabilitation of cerebral palsy children and adolescents: a systematic review. Front Neurol. 2023 May 25;14:1171224. doi: 10.3389/fneur.2023.1171224. eCollection 2023.
citation: 8. Kisner, C., Colby, L. A., Borstad, J. (2022). Therapeutic Exercise: Foundations and Techniques. United States: F.A. Davis.
citation: Monticone M, Ambrosini E, Cazzaniga D, Rocca B, Ferrante S. Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial. Eur Spine J. 2014 Jun;23(6):1204-14. doi: 10.1007/s00586-014-3241-y. Epub 2014 Feb 28.
citation: 11. Martin, S. C.(2018). Spinal Asymmetry and Scoliosis: Movement and Function Solutions for the Spine, Ribcage and Pelvis. p. 213. Jessica Kingsley Publishers.
citation: 15. Mendoza, A. et all. (Ed) (2023, July 20).
citation: 13. Lenhert-Schroth, C. (2007). The Schroth scoliosis three dimensional treatment. Books on Demand GmbH. https://books.google.com.tr/books?id=D0gQAQAAMAAJ&dq=9780914959021,&hl=en&newbks=1&newbks_redir=1&sa=X&ved=2ahUKEwibwbfyp82JAxV_RfEDHZbSG3IQ6AF6BAgGEAI