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Cerebral Palsy (CP)NCT06781047

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

A study testing Trunk Focused Rehabilitation (TFR) and Conventional Rehabilitation (CR) in people with Cerebral Palsy (CP) and Adolescent, run by Saglik Bilimleri Universitesi at 3 sites in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Cerebral Palsy (CP), Adolescent, Trunk
What is being tested?
Trunk Focused Rehabilitation (TFR) and Conventional Rehabilitation (CR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesTurkey (Türkiye)
Study dates
15 May 2024to 25 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Gül EVDALI, MScPT contact

+90 544 368 60 26 ext. +90

gulevdali@hotmail.com

Turkey (Türkiye)3 sites, 1 recruiting

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

    Ankara, Etimesgut, 06790

    Completed

  • Private Etimesgut Kardelen Special Education and Rehabilitation Center

    Ankara, Etimesgut, 06794

    Completed

  • SERÇEV Barrier-Free and Vocational Technical Anatolian High School

    Ankara, Çankaya, 06810

    Gül EVDALI, MScPT, +90 544 368 60 26, gulevdali@hotmail.com

    Gül EVDALI, MScPT

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Serebral Palsili Adölesanlarda Gövde Odaklı Rehabilitasyonun Spinal Mobilite, Gövde Kontrolü ve El Fonksiyonları Üzerine Etkilerinin İncelenmesi

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.

Read the 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.

Being tested
Trunk Focused Rehabilitation (TFR), Conventional Rehabilitation (CR)
Keywords
cerebral palsy, trunk training, trunk control exercise
Medical subject headings
Cerebral Palsy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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
Study groups in NCT06781047
Study groupRoleWhat they receive
Trunk Focused Rehabilitation (TFR) plus Conventional Rehabilitation (CR) GroupExperimental1. 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.
Receives: Other: Trunk Focused Rehabilitation (TFR); Other: Conventional Rehabilitation (CR)
Conventional Rehabilitation (CR) GroupActive comparatorThe 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.
Receives: Other: Conventional Rehabilitation (CR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at baseline and week 9

  2. 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.

    Measured: at baseline and week 12

  3. 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.

    Measured: at baseline and week 9

Secondary outcomes (2)

  1. 1 Minute Walking Test (1-MWT):

    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.

    Measured: at baseline and week 9

  2. Pediatric Data Collection Tool (PODCI)

    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.

    Measured: at baseline and week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study start15 May 2024
  3. Primary completion25 May 2025 (estimated)
  4. Study completion25 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Clinical Trial
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06781047
Sponsor's protocol ID
Saglik Bilimleri U, 26848
Other IDs
0000-0002-4321-2332, 0000-0001-9120-7071
Status last verified
Aug 2024
First submitted
13 Jan 2025
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 25523410

  • 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.

  • 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.

    PubMed 32036426

  • 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.

    PubMed 36959769

  • 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.

    PubMed 37021364

Questions about this trial

What is this clinical trial studying?

A study testing Trunk Focused Rehabilitation (TFR) and Conventional Rehabilitation (CR) in people with Cerebral Palsy (CP) and Adolescent, run by Saglik Bilimleri Universitesi at 3 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gül EVDALI, MScPT (+90 544 368 60 26 ext. +90, gulevdali@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Trunk Control (time frame: at baseline and week 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06781047, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.

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