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

NCT ID: NCT06781047

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2025-06-25

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.

Conditions

Cerebral Palsy (CP); Adolescent; Trunk; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trunk Focused Rehabilitation (TFR) plus Conventional Rehabilitation (CR) Group

1. Abdominal stabilization progression for TFR is applied to all cases with simultaneous breathing exercises for 8 weeks (24 sessions in total) (8). Exercises are performed 3 days a week, 45 minutes a day, starting from warm-up and recumbent position respectively, and the intensity is adjusted individually by observing tone and motivation.

The experimental group's routine physiotherapists also gave them a conventional rehabilitation program (the same protocol as in the active comparison arm) for 40 minutes per day, 2 days per week.

Group Type: EXPERIMENTAL

Trunk Focused Rehabilitation (TFR)

Intervention Type: OTHER

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 exercises(12).

Cooling Down: Warm-up exercises are repeated.

2. General Posture and Asymmetry Training Brochure (includes adolescent, family, and team members)(13-17).

The exercise starts with 3 seconds and gradually progresses to 10 seconds, 10 repetitions, and 3 sets.

The TFR group also receives Conventional Treatment 2 days a week, 40 minutes per day, for 8 weeks. The same treatment protocol is applied as the control group). Routine physiotherapists apply conventional treatment.

Conventional Rehabilitation (CR)

Intervention Type: OTHER

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 descending stairs

8. Weight transfer exercises at standing, sitting

Conventional Rehabilitation (CR) Group

The control group is the group that receives conventional treatment 2 days a week, 40 minutes per session.

Conventional Rehabilitation Program Content: All sessions include the following rehabilitation program, supervised by a physiotherapist and individualized according to tolerance. Number of exercise repetitions: 10-20. The intensity is adjusted by observing motivation.

Group Type: ACTIVE_COMPARATOR

Conventional Rehabilitation (CR)

Intervention Type: OTHER

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 descending stairs

8. Weight transfer exercises at standing, sitting

Interventions

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 exercises(12).

Cooling Down: Warm-up exercises are repeated.

2. General Posture and Asymmetry Training Brochure (includes adolescent, family, and team members)(13-17).

The exercise starts with 3 seconds and gradually progresses to 10 seconds, 10 repetitions, and 3 sets.

The TFR group also receives Conventional Treatment 2 days a week, 40 minutes per day, for 8 weeks. The same treatment protocol is applied as the control group). Routine physiotherapists apply conventional treatment.

Intervention Type: 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 descending stairs

8. Weight transfer exercises at standing, sitting

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seval KUTLUTÜRK YIKILMAZ, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences Hamidiye Faculty of Health Sciences

Orçun TOKTAŞ, Op. Dr

Role: PRINCIPAL_INVESTIGATOR

Etimesgut Şehit Sait Ertürk State Hospital Orthopedics and Traumatology.

Gül EVDALI, MScPT

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences Hamidiye Health Sciences Institute

Locations

Sacettin Gürbüz Barrier-Free Life Center (General name of the campus.) /*Private Etimesgut Barrier-Free Life Special Education and Rehabilitation Center

Ankara, Etimesgut, Turkey (Türkiye)

Site Status: COMPLETED

Private Etimesgut Kardelen Special Education and Rehabilitation Center

Ankara, Etimesgut, Turkey (Türkiye)

Site Status: COMPLETED

SERÇEV Barrier-Free and Vocational Technical Anatolian High School

Ankara, Çankaya, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Gül EVDALI, MScPT

Role: CONTACT

gulevdali@hotmail.com

+90 544 368 60 26 ext. +90

Facility Contacts

Gül EVDALI, MScPT

Role: primary

gulevdali@hotmail.com

+90 544 368 60 26

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 25523410 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 32036426 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36959769 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37021364 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37305763 (View on PubMed)

8. Kisner, C., Colby, L. A., Borstad, J. (2022). Therapeutic Exercise: Foundations and Techniques. United States: F.A. Davis.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 24682356 (View on PubMed)

11. Martin, S. C.(2018). Spinal Asymmetry and Scoliosis: Movement and Function Solutions for the Spine, Ribcage and Pelvis. p. 213. Jessica Kingsley Publishers.

Reference Type: BACKGROUND

15. Mendoza, A. et all. (Ed) (2023, July 20).

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Study Documents

Document Type: Statistical Analysis Plan

The study data is shared with the official at the website https://www.akademikredaksiyon.com/ for statistical analysis and evaluation of the results.

View Document

Related Links

https://books.google.com.tr/books?id=apxhEAAAQBAJ

1\. Giannoni, P., \& Zerbino, L. (2022). Cerebral Palsy: A Practical Guide for Rehabilitation Professionals. In Google Books. Springer Nature. https://books.google.com.tr/books?id=apxhEAAAQBAJ

https://pubmed.ncbi.nlm.nih.gov/25523410/

2\. Dewar, R., Love, S., \& Johnston, L. M. (2015). Exercise interventions improve postural control in children with cerebral palsy: a systematic review. Developmental medicine and child neurology, 57(6), 504-520. https://doi.org/10.1111/dmcn.12660

https://dergipark.org.tr/tr/pub/tfrd/issue/45078/382366

3\. Numanoğlu Akbaş, A., \& Kerem Günel, M. (2019). EFFECTS OF INDIVIDUALLY STRUCTURED TRUNK TRAINING ON BODY FUNCTION AND STRUCTURES IN CHILDREN WITH SPASTIC CEREBRAL PALSY: A STRATIFIED RANDOMIZED CONTROLLED TRIAL. Fizyoterapi Rehabilitasyon, 30(1),11-22

https://pubmed.ncbi.nlm.nih.gov/32036426/

4\. Ruthard, Kristina et al. "Reliability of a radiation-free, noninvasive and computer-assisted assessment of the spine in children with cerebral palsy." European spine journal : official publication of the European Spine Society.

https://pubmed.ncbi.nlm.nih.gov/36959769/

5\. Pierret, Jonathan et al. "Rehabilitation of Postural Control and Gait in Children with Cerebral Palsy: the Beneficial Effects of Trunk-Focused Postural Activities." Developmental neurorehabilitation vol. 26,3 (2023): 180-192. doi:10.1080/17518423.2023

https://pubmed.ncbi.nlm.nih.gov/37305763/

6\. Faccioli, S., Pagliano, E., Ferrari, A., Maghini, C., Siani, M. F., Sgherri, G., Cappetta, G., Borelli, G., Farella, G. M., Foscan, M., Viganò, M., Sghedoni, S., Perazza, S., \& Sassi, S. (2023). Evidence-based management and motor rehabilitation of ce

https://pubmed.ncbi.nlm.nih.gov/37021364/

7\. Talgeri, A. J., Nayak, A., Karnad, S. D., Jain, P., Tedla, J. S., Reddy, R. S., \& Sangadala, D. R. (2023). Effect of Trunk Targeted Interventions on Functional Outcomes in Children with Cerebral Palsy- A Systematic Review. Developmental neurorehabilit

https://books.google.com.tr/books?id=xKegEAAAQBAJ

8\. Kisner, C., Colby, L. A., \& Borstad, J. (2022). Therapeutic Exercise : Foundations and Techniques. In Google Books. F.A. Davis. https://books.google.com.tr/books?id=xKegEAAAQBAJ

https://www.amazon.com/Three-Dimensional-Treatment-Scoliosis-Physiotherapeutic-Deformities/dp/0914959026

9\. Schroth, C. L. (2007). Three-Dimensional Treatment for scoliosis: a physiotherapeutic method for deformities of the spine: 9780914959021: Medicine \& Health Science Books @ Amazon.com (C. Mohr, A. Reeves, \& D. A. Smith, Trans.; 1st English edition). Th

https://doi.org/10.21020/husbfd.601264

10\. Kuru Çolak, T., Akçay, B., \& Apti, A. (2020). Skolyoz Tedavisinde Schroth Yöntemi. Hacettepe University Faculty of Health Sciences Journal, 7(1), 1-12. https://doi.org/10.21020/husbfd.601264

https://books.google.com.tr/books?id=3-TvkJgmE6cC&source=gbs_navlinks_s

11\. Esquerdo, O. M. (2016). Stretching Exercises Encyclopedia. In Google Books: Vol. p. 52 (illustrated ed.). Meyer \& Meyer Verlag. https://books.google.com.tr/books?id=3-TvkJgmE6cC\&source=gbs\_navlinks\_s

https://pubmed.ncbi.nlm.nih.gov/24682356/

12\. Monticone, M., Ambrosini, E., Cazzaniga, D., Rocca, B., \& Ferrante, S. (2014). 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

https://search.library.ucsf.edu/permalink/01UCS_SAF/88i771/alma991000017589706536

13\. Kotwicki, T., \& Grivas, T. B. (2012). Research into spinal deformities 8.

https://books.google.com.tr/books?id=hJhsvgAACAAJ

14\. Martin, S. C. (2018). Spinal Asymmetry and Scoliosis: movement and function solutions for the spine, ribcage and pelvis. In Google Books: Vol. p.213 (illustrated ed.). Jessica Kingsley Publishers. https://books.google.com.tr/books?id=hJhsvgAACAAJ

https://www.scribd.com/document/742070779/The-ScoliClinic-5-Tips-For-Supporting-Your-Scoliosis-While-You-Sleep

15\. Mendoza et all, 2023, para.1-4.

https://www.google.com.tr/books/edition/Yoga_and_Scoliosis/qaJrmefYYcwC?hl=tr&gbpv=1&dq=good%20sitting%20scoliosis&pg=PA237&printsec=frontcover

16\. Monroe, M. (2012). Yoga and Scoliosis: A Journey to Health and Healing (16pt Large Print Edition). ReadHowYouWant.

https://www.google.com.tr/books/edition/Scoliosis_Yoga_Therapy_and_the_Art_of_Le/DuXiDAAAQBAJ?hl=en&gbpv=0

17\. Krentzman, R. (2016). Scoliosis, Yoga Therapy, and the Art of Letting Go. Birleşik Krallık: Jessica Kingsley Publishers.p.53-57

Other Identifiers

0000-0002-4321-2332

Identifier Type: REGISTRY

Identifier Source: secondary_id

0000-0001-9120-7071

Identifier Type: REGISTRY

Identifier Source: secondary_id

Saglik Bilimleri U, 26848

Identifier Type: -

Identifier Source: org_study_id