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

February 4, 2025 updated by: Saglik Bilimleri Universitesi

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Etimesgut
      • Ankara, Etimesgut, Turkey, 06790
        • Completed
        • Sacettin Gürbüz Barrier-Free Life Center (General name of the campus.) /*Private Etimesgut Barrier-Free Life Special Education and Rehabilitation Center
      • Ankara, Etimesgut, Turkey, 06794
        • Completed
        • Private Etimesgut Kardelen Special Education and Rehabilitation Center
    • Çankaya
      • Ankara, Çankaya, Turkey, 06810
        • Recruiting
        • SERÇEV Barrier-Free and Vocational Technical Anatolian High School
        • Contact:
        • Contact:
          • Gül EVDALI, MScPT
        • Contact:
          • Orçun TOKTAŞ, Op. Dr
        • Contact:
          • Seval KUTLUTÜRK YIKILMAZ, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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
Experimental: 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.
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 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Trunk Control
Time Frame: at baseline and week 9
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
Time Frame: at baseline and week 12
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
Time Frame: at baseline and week 9
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 Minute Walking Test (1-MWT):
Time Frame: at baseline and week 9
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.
at baseline and week 9
Pediatric Data Collection Tool (PODCI)
Time Frame: at baseline and week 9
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.
at baseline and week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Estimated)

May 25, 2025

Study Completion (Estimated)

June 25, 2025

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Saglik Bilimleri U, 26848
  • 0000-0002-4321-2332 (Registry Identifier: Gül EVDALI)
  • 0000-0001-9120-7071 (Registry Identifier: Seval KUTLUTÜRK YIKILMAZ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: gulevdali@hotmail.com
    Information comments: The study data is shared with the official at the website https://www.akademikredaksiyon.com/ for statistical analysis and evaluation of the results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adolescent

Clinical Trials on Trunk Focused Rehabilitation (TFR)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe