NCT06781047

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
Last Updated

February 7, 2025

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

January 13, 2025

Last Update Submit

February 4, 2025

Conditions

Cerebral Palsy (CP)AdolescentTrunkExercise

Keywords

cerebral palsy, trunk training, trunk control exercise

Outcome Measures

Primary Outcomes (3)

  • Evaluation of Trunk Control

    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.

    at baseline and week 9

  • Evaluation of Spinal Mobility

    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.

    at baseline and week 12

  • Evaluation of Hand Functions

    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.

    at baseline and week 9

Secondary Outcomes (2)

  • 1 Minute Walking Test (1-MWT):

    at baseline and week 9

  • Pediatric Data Collection Tool (PODCI)

    at baseline and week 9

Study Arms (2)

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

EXPERIMENTAL

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.

Other: Trunk Focused Rehabilitation (TFR)Other: Conventional Rehabilitation (CR)

Conventional Rehabilitation (CR) Group

ACTIVE COMPARATOR

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.

Other: Conventional Rehabilitation (CR)

Interventions

Trunk Focused Rehabilitation (TFR)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.

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

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Ankara, Etimesgut, 06790, Turkey (Türkiye)

COMPLETED

Private Etimesgut Kardelen Special Education and Rehabilitation Center

Ankara, Etimesgut, 06794, Turkey (Türkiye)

COMPLETED

SERÇEV Barrier-Free and Vocational Technical Anatolian High School

Ankara, Çankaya, 06810, Turkey (Türkiye)

RECRUITING

Related Publications (12)

  • 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

    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.

    PMID: 25523410BACKGROUND

  • 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.

    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.

    PMID: 32036426BACKGROUND

  • 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.

    PMID: 36959769BACKGROUND

  • 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.

    PMID: 37021364BACKGROUND

  • 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: 37305763BACKGROUND

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

    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.

    PMID: 24682356BACKGROUND

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

    BACKGROUND

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

    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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • Seval KUTLUTÜRK YIKILMAZ, PhD

    University of Health Sciences Hamidiye Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

  • Orçun TOKTAŞ, Op. Dr

    Etimesgut Şehit Sait Ertürk State Hospital Orthopedics and Traumatology.

    PRINCIPAL INVESTIGATOR

  • Gül EVDALI, MScPT

    University of Health Sciences Hamidiye Health Sciences Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gül EVDALI, MScPT

CONTACT

+90 544 368 60 26gulevdali@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 17, 2025

Study Start

May 15, 2024

Primary Completion

May 25, 2025

Study Completion

June 25, 2025

Last Updated

February 7, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Statistical Analysis Plan (gulevdali@hotmail.com)Access

Locations

TU(3)