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

Overview

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.

Interventions

• Other Trunk Focused Rehabilitation (TFR)
  Abdominal stabilization progression for TFR is applied with simultaneous breathing exercise for 3 days a week, 45 minutes a day, 8 weeks (24 sessions in total)(8). 1. Basic Abdominal Stabilization Training, Task-Focused Exercises (without spinal diagonal and rotational components)(8,12). Warm-up: 5 minutes, Global Stretching and Relaxation(9,10,11). Extremity load, elastic band, and unstable surface are added as stabilization is achieved in neurodevelopmental positions. Task-oriented exerci
• Other Conventional Rehabilitation (CR)
  Conventional treatment is applied to the group, 2 days a week, 40 minutes each session, for 8 weeks. It is an intervention performed by a physiotherapist who regularly follows up in a special education and rehabilitation center. 1. Normal Joint Movement (NEH) 2. Stretching for the lower, and upper extremities and around the hips 3. Lying activities 4. Curl up (assisted, unaided) 5. Bridging exercise, cat camel exercise, posterior pelvic tilt exercise 6. Walking training 7. Climbing and descendi

Primary outcome measures

• Evaluation of Trunk Control [Time frame: at baseline and week 9]
• Evaluation of Spinal Mobility [Time frame: at baseline and week 12]
• Evaluation of Hand Functions [Time frame: at baseline and week 9]

Secondary outcome measures (2)

• 1 Minute Walking Test (1-MWT): [Time frame: at baseline and week 9]
• Pediatric Data Collection Tool (PODCI) [Time frame: at baseline and week 9]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 3 centers

• Sacettin Gürbüz Barrier-Free Life Center (General name of the campus.) /*Private Etimesgut — Ankara
• Private Etimesgut Kardelen Special Education and Rehabilitation Center — Ankara
• SERÇEV Barrier-Free and Vocational Technical Anatolian High School — Ankara

Publications

• 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
• 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. PMID 37305763
• 8. Kisner, C., Colby, L. A., Borstad, J. (2022). Therapeutic Exercise: Foundations and Techniques. United States: F.A. Davis.
• 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. PMID 24682356
• 11. Martin, S. C.(2018). Spinal Asymmetry and Scoliosis: Movement and Function Solutions for the Spine, Ribcage and Pelvis. p. 213. Jessica Kingsley Publishers.
• 15. Mendoza, A. et all. (Ed) (2023, July 20).
• 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
• 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. PMID 25523410

Identifiers

NCT: NCT06781047 · Saglik Bilimleri U, 26848 · 0000-0002-4321-2332 · 0000-0001-9120-7071

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗